Alerts & Flash

ALERTS

  • Corporate
    Covid-19: MCA relaxes residency requirement of 182 days

    Through General Circular  No. 36/2020 dated October 20, 2020, the Ministry of Corporate Affairs (“MCA”) has exempted directors and designated partners from complying with the minimum residency requirement of 182 days for Financial Year (“FY”) 2020-21.

    Background: As per section 149(3) of the Companies Act, 2013 (“CA 2013”), every company needs to have at least one director who stays in India for at least 182 days during every FY. A similar requirement is there for designated partners under section 7(1) of Limited Liability Partnership Act, 2008 (“LLP Act”). Read More

  • Litigation
    Amendment of default threshold prospective in nature, holds NCLAT

    On March 24, 2020, the Indian government had, on account of the pandemic, amended section 4 of the Insolvency and Bankruptcy Code, 2016 (“IBC”) to increase the minimum amount of default for initiating insolvency process against corporate debtors from INR 1 Lakh (USD 1,400) to INR 1 Crore (USD 1.4 million) (“March 24 notification”). Since then, the March 24 notification has been subject to judicial interpretation to examine whether the revised threshold has prospective or retrospective application. On October 12, 2020, the National Company Law Appellate Tribunal (“NCLAT”), in Madhusudan Tantia v. Amit Choraria and Ors. (“Foseco decision”) held that the March 24 notification will have prospective application.

    Facts: Between March 2018 and July 2019, Foseco India Limited (“Operational Creditor”) raised multiple invoices against Om Boseco Rail Products Limited (“Corporate Debtor”) for supply of foundry and chemicals, which remain unpaid. Read More

  • FCRA
    FCRA Amendment Act, 2020

    Despite requests for parliamentary committee consultations, on September 29, 2020, the controversial Foreign Contribution (Regulation) Amendment Act, 2020 (“Amendment Act”) came into force, i.e. a week after the bill was introduced in the Lok Sabha. This alert analyses some key changes under the Amendment Act.

    1. Prohibition to transfer foreign contribution to “any other person”: The amended section 7 prohibits a person registered or having prior permission under the Foreign Contribution (Regulation) Act, 2010 (“FCRA”) to transfer foreign contribution received by it to “any other person”.

    PSA view: Non-profits that are registered or have obtained prior permission under FCRA can no longer sub-grant foreign contribution received by them to “any other person”. As per section 2(1)(m) of FCRA, the term person includes individuals, HUFs, associations and companies with charitable objects registered under the Companies Act. Prior to the Amendment Act, non-profits were allowed to transfer foreign contribution to (i) persons registered or having prior permission under FCRA and/or (ii) persons not registered or having permission under FCRA, with prior approval of the Indian government. Read More

  • Corporate 
    Extension for Online EGMs

    The Ministry of Corporate Affairs (“MCA”) allowed convening of Extra-ordinary General Meetings (“EGMs”) on or before June 30, 2020 through Video Conferencing (“VC”) or any Other Audio-visual Means (“OAVM”) without the physical presence of any shareholder by General Circular 14/2020 and 17/2020 issued in April, 2020. The Companies Act, 2013 does not contain any provision with respect to convening general meetings through electronic mode.

    Further, by General Circular 22/2020 issued on June 15, 2020, the deadline for convening EGMs through electronic mode was extended till September 30, 2020. Recently, by General Circular 33/2020 of September 28, 2020, the MCA has again extended the deadline till December 31, 2020. Read More

  • Corporate
    Covid-19: Extension for CFSS and LLPSS 2020

    The Ministry of Corporate Affairs (“MCA”) had announced Companies Fresh Start Scheme, 2020 (“CFSS Scheme”) and Limited Liability Partnership Settlement Scheme, 2020 (“LLPS Scheme”) in March 2020 to provide companies and Limited Liability Partnerships (“LLPs”) an opportunity to remain compliant by filing pending forms, returns, statements, documents which were required to be filed with the MCA within the stipulated time but could not be filed. Companies and LLPs were allowed to avail benefits under their respective schemes between April 1 – September 30, 2020 by filing all their pending forms under the Companies Act, 2013 (“the Act”) and LLP Act, 2008 respectively.

    Recently on September 28, 2020, the MCA has extended the validity of CFSS Scheme and LLPS Scheme by General Circular 30/2020 and 31/2020 respectively, till December 31, 2020 due to the ongoing pandemic. This comes as a major relief for companies and LLPs. Read More

  • Corporate
    Covid-19: Automatic AGM extension

    On September 8, 2020, the Registrar of Companies (“ROC”) granted an automatic extension of 3 months for holding Annual General Meeting (“AGM”) for Financial Year (“FY”) 2019-20. This comes as a major relief for companies during this pandemic.

    What is AGM extension:As per section 96 of the Companies Act, 2013, every company is required to hold its first AGM within 9 months from the end of its first FY and subsequent AGMs within 6 months from the end of every FY. If any company is unable to hold its subsequent AGM on or before the due date i.e. September 30, it can apply for extension of a maximum of 3 months in form GNL-1 with concerned ROC. Read More

  • Corporate
    Covid-19: Expansion of CSR Activities

    Given the COVID-19 crisis, the Ministry of Corporate Affairs (“MCA”) has been taking many initiatives to support Corporate India including initiatives pertaining to Corporate Social Responsibility (“CSR”). Recently, the MCA expanded the scope of CSR activities by amending item (ix) of Schedule VII and introducing the Companies (CSR Policy) Amendment Rules, 2020.

    Background:As per section 135 of the Act, any company with a profit of INR 50 million (USD 650,000) or turnover of INR 1 billion (USD 14 million) or net worth of INR 5 billion (USD 70 million) or more in the preceding financial year is required to expend at least 2% of three years’ average net annual profit on CSR activities specified under Schedule VII of the Act. Read More

  • Corporate
    MCA clarification on AGM extension

    With respect to the Annual General Meetings (“AGMs”), the Ministry of Corporate Affairs (“MCA”) came up with a general circular 18/2020 providing the companies, whose Financial Year (“FY”) ended on December 31, 2019, an extension of 3 months to convene an AGM. Subsequently, the MCA issued a General Circular 20/2020 on May 5, 2020 allowing the companies, whose FY ended on March 31, 2020, to convene their AGM through Video Conferencing (“VC”) or any Other Audio-Visual Means (“OAVM”). Now, the MCA has issued a clarification by way of General Circular 28/2020 (“Circular”) on August 17, 2020 pertaining to the AGMs to be held for FY ended on March 31, 2020, clarifying that no general extension will be granted. Read More

  • Corporate
    MCA amends provisions with respect to Sweat Equity Shares

    On June 5, 2020, the Ministry of Corporate Affairs (“MCA”) amended the Companies (Share Capital and Debentures) Rules, 2014 (“SCD Rules”) and issued the Companies (Share Capital and Debentures) Amendment Rules, 2020 (“Revised SCD Rules”). This alert apprises you with the amendment pertaining to issue of Sweat Equity Shares (“Sweat Equity”).

    Background:As per section 54 of the Companies Act, 2013 and Rule 8(1) of SCD Rules, Sweat Equity is one of the modes of incentivizing permanent employees (including directors) to accept stock and participate in the growth of the company. In order to issue Sweat Equity, companies are required to pass a special resolution in a general meeting. As per Rule 8(2) of SCD Rules, the explanatory statement annexed to the notice of the general meeting must include key details such as reasons for the issue; name and class of directors or employees to whom such equity shares are to be issued and their relationship with the promoter or/and key managerial personnel; principal terms and conditions; basis of valuation of share; any breach in ceiling of managerial remuneration due to this issue and the proposal to deal with such breach; and diluted earning per share pursuant to the issue. Read More

  • Corporate
    Covid-19: MCA allows convening AGMs electronically

    The Companies Act, 2013 (“the Act”) does not contain any provision with respect to convening general meetings through electronic mode. Earlier, by general circular 14/2020 and 17/2020, the Ministry of Corporate Affairs (“MCA”) allowed EGMs through video conferencing (“VC”) or any other audio-visual means (“OAVM”) with a view to support corporate India on account of the pandemic. Subsequently, it came up with another general circular 18/2020 providing the companies, whose Financial Year (“FY”) ends on December 31 every year, an extension of 3 months to convene Annual General Meetings (“AGMs”). Now, the MCA has issued a General Circular 20/2020 on May 5, 2020 (“Circular”) allowing all companies to convene AGMs through VC or OAVM. Read More

  • Litigation
    Covid-19: Impact on Indian Courts | Follow-up 3

    In view of the extension of the lockdown in India, the functioning of the courts continues to remain extremely negligible. Various courts and forums have issued renewed notifications which are highlighted below:

    1. Supreme Court: This court continues to hear only limited and urgent matters.On April 15, 2020, SC issued another Standard Operating Procedure detailing the process for mentioning, e-filing and video conferencing hearing of urgent matters which supplements the previous SOP issued on March 23 and 26, 2020.

    2. High Court of Delhi: On April 15, 2020, Delhi HC passed an office order whereby it suspended its functioning and of all the subordinate courts in Delhi till May 03, 2020. However, it increased the number of benches hearing urgent matters.  On April 22, it modified the procedure for mentioning urgent matters. Now, instead of mentioning urgent matters on telephone, a link is made available from 10:30 am to 12:00 noon on all working days. In addition, by way of an office order dated April 26, 2020, the DHC increased the scope of urgent matters and decided to hear matters pending at the stage of final hearing under various categories. The order provides a detailed list of these categories along with conditions required to be fulfilled by the parties for the matter to be listed for hearing. Read More

  • Corporate
    Covid-19: Extension of AGM for companies whose FY ended on Dec. 31, 2019

    By a general circular 18/2020 issued on April 21, 2020, the Ministry of Corporate Affairs (“MCA”) extended the due date for Annual General Meeting (“AGM”) from June 30, 2020 to September 30, 2020 of companies whose Financial Year (“FY”) followed the calendar year basis, i.e. ended on December 31, 2019.

    Background:As per section 96 of the Companies Act, 2013 (“the Act”), every company is required to hold its first AGM within 9 months of the end of its first FY. This period reduces to 6 months for all subsequent AGMs. As per section 2(41) of the Act, FY should commence from April 1 to March 31 of the following year. However, in case of an Indian holding or subsidiary or associate company of a company incorporated outside India, the Indian company can make an application to Central Government for following a different FY in order to align its FY with such foreign company for consolidating its accounts outside India. Read More

  • Corporate
    SEBI finally notifies securities regulatory sandbox!

    As a major move towards encouraging innovation in fintech sector, the Securities and Exchange Board of India (SEBI) notified the SEBI Regulatory Sandbox Amendment Regulations, 2020 on April 17. The notification amends about 33 regulations including issue and listing of instruments, takeover code, foreign venture capital investor, real estate investment trusts, listing obligations and disclosure requirements, foreign portfolio investors, stock brokers, debenture trustees, merchant bankers, underwriters, share transfer agents, mutual funds and custodian regulations. A copy of the notification can be accessed at http://egazette.nic.in/WriteReadData/2020/219076.pdf. Read More

  • Corporate
    MCA clarification on online EGMs

    By a general circular 14/2020 dated April 8, 2020, the Ministry of Corporate Affairs (“MCA”) allowed the companies to convene Extra-ordinary General Meetings (“EGMs”) through video conferencing or any other audio-visual means without the physical presence of any shareholder. Due to some ambiguities in this circular, MCA came up with general circular 17/2020 on April 13, 2020.

    Key clarifications of the April 13 circular are:

    1. Issue of EGM notice

    • Notices are allowed to be circulated through e-mail only; Read More
  • FDI
    Press Note 3/2020: Chinese Investments in India Targeted

    On April 17, 2020 the Ministry of Commerce, acting through the Department for Promotion of Industry and Internal Trade issued a Press Note or PN 3 of 2020 through which it aims to curb “opportunistic takeovers/acquisitions of Indian companies” on account of COVID-19. Currently, foreign companies can invest in India through the “automatic” or “government” routes. The former does not require any prior investment approval while the latter does. Apart from other applicable conditions, of course, the investment has to be in sectors where foreign participation is permissible, and not prohibited. Even at present, organization and individuals from Bangladesh and Pakistan can invest only after securing prior government approval and, in addition, Pakistan cannot invest in atomic energy, defense, space and, of course, all other sectors where foreign investment is not permissible. Pursuant to the aforesaid PN, the revised position is as follows:  Read More

  • Telecom
    Exemptions for WFH facility under OSP registration

    Vide its letter dated March 13, 2020, the Department of Telecommunications (“DoT”) had granted temporary exemptions from some conditions for Work From Home (“WFH”) facility under the Other Service Provider (“OSP”) registration. On April 15, 2020, the DoT partially modified its earlier letter with an aim to allow greater transparency and flexibility to OSPs. The two key changes are summarized below:

    • The March 13 letter dispensed the requirement for the OSP to put in place a secured VPN facility from an authorized service provider. Instead, OSPs were allowed to self-configure a secured VPN using static IP addresses for interconnection between the OSP center and locations of its home agents. Now, pursuant to the April 15 clarification, OSPs may use either static or dynamic IP addresses (out of a pool private IP assigned for WFH) for interconnection purposes; and Read More
  • Competition
    CCI Announces Further Measures: An Opportunity for the Future?

    In wake of the COVID-19 pandemic, the Competition Commission of India (“CCI”) has on April 13, 2020, announced further relaxations and clarifications concerning matters involving anti-competitive agreements, abuse of dominance, combination filings and other compliances under the Competition Act. These are in furtherance of CCI’s public notices dated March 23 (https://www.cci.gov.in/sites/default/files/whats_newdocument/scan1.pdf) and 30 (https://www.cci.gov.in/sites/default/files/whats_newdocument/30thcircular.pdf), 2020, respectively. The recent notice dated April 13 can be accessed at: https://www.cci.gov.in/sites/default/files/whats_newdocument/COVID-19.pdf  Read More

  • Employment
    Relief for Employers: New contribution scheme under EPF Act

    The Central Government on March 26, 2020 announced allocation of INR 17 million as relief under the Pradhan Mantri Garib Kalyan Yojana to prevent employment disruption and support small businesses during COVID-19 times. The relief shall be used towards monthly contribution for eligible employees under the Employees’ Provident Fund and Miscellaneous Provisions Act (EPF Act). Pursuant to this, Employees’ Provident Fund Office, Ministry of Labour (EPFO) has issued detailed scheme and guidelines through office memo of April 9, 2020 (No. C-I/Misc./2020-2021/Vol. II/Pt). The scheme and related information for availing benefit are hosted on EPFO’s website and can be accessed here.  Read More

  • Corporate
    Covid-19: MCA allows convening EGMs electronically

    In an effort to continue to support corporate India, the Ministry of Corporate Affairs (“MCA”) has issued yet another General Circular 14/2020 on April 8, 2020 (“Circular”) for promoting social distancing while convening of Extra-ordinary General Meetings (“EGMs”). The Companies Act, 2013 (“the Act”) does not contain any provision with respect to convening general meetings through electronic mode. Only board meetings were previously allowed to be held electronically. By this Circular, companies can now convene EGMs through video conferencing (“VC”) or any other audio-visual means (“OAVM”) without the physical presence of any shareholder. All other provisions with respect to convening of general meetings will remain the same.  Read More

  • Litigation
    Covid-19: Impact on Indian Courts | Follow-up 2

    This alert lists additional notifications issued by the courts and tribunals.
    1. Supreme Court: On April 06, 2020, SC passed another suo moto order and provided additional guidelines for functioning of courts through video conferencing. It stated (a) All measures that have been and shall be taken by SC and various High Courts to secure functioning of courts with social distancing guidelines shall be deemed to be lawful; (b) SC and HC’s are authorized to adopt measures to ensure healthy functioning of the judicial system through video conferencing; (c) A help-line no. shall be created for each HC; (d) District Courts to also adopt video conferencing and HCs to frame specific rules for them. Read More

  • Corporate
    An Opportunity: MCA relaxes payment of additional fee in case of pending filings

    In the wake of COVID-19, the Ministry of Corporate Affairs (“MCA”) has announced a Companies Fresh Start Scheme, 2020 (“the CFSS Scheme”) through a general circular 12/2020 dated March 30, 2020 and a Limited Liability Partnership Settlement Scheme, 2020 (“the LLP Scheme”) through general circular 6/2020 of March 4, 2020 read with general circular 13/2020 of March 30, 2020.

    Applicability:The schemes provide companies and Limited Liability Partnerships (“LLPs”) an opportunity to remain compliant by filing pending forms, returns, statements, documents which were required to be filed with the MCA. Read More

  • Litigation
    Covid-19: Impact on Indian Courts | Follow-up 1

    In view of the 21-day lockdown and the notification of March 25, 2020, the Delhi High Court directed suspension of work at its premises and all subordinate courts to continue till April 15, 2020. This is being followed by almost all courts and tribunals. This alert is a follow-up to our litigation alert dated March 26, 2020 and describes additional notifications issued by the following tribunals:

    1. NCLAT:On March 30, 2020, NCLAT passed a suo moto order and directed two points. Firstly, NCLAT and all benches of NCLT will exclude the lockdown period for counting the period for resolution process under Section 12 of IBC, 2016 in all cases where the corporate insolvency resolution process has been initiated. Secondly, all interim order(s) passed by NCLAT in (a) insolvency; (b)company and (c)competition matters shall continue till the next date of hearing. Read More

  • Employment
    Employment in Covid-19 Times: 15 Frequent Queries

    On March 24, 2020, the government ordered a nation-wide lockdown for 21 days effective from March 25, 2020 (“CG Notification”). Amidst this unprecedented situation, organizations have been grappling with various issues confronting employment policies and practices. This FAQ captures some of the frequent queries we have been asked over the past couple of weeks and we hope they are useful for organisations facing similar concerns. Read More

  • Corporate
    Covid-19: Relief measures by Finance Minister pertaining to Corporate Affairs

    In view of COVID-19, Nirmala Sitharaman, Finance and Corporate Affairs Minister, announced certain relief measures on March 24, 2020 which were then officially notified by the Ministry of Corporate Affairs (“MCA”) through its General Circular 11/2020 dated March 24, 2020. This alert follows up on our last update of March 24 available here https://www.psalegal.com/mca-initiatives-to-deal-with-covid-19/:

    1. Additional fee:All additional fee on account of late filing of e-forms has been done away with for 6 months. This moratorium period is from April 1, 2020 till September 30, 2020. The MCA will issue a separate circular with detailed clarifications; Read More

  • Covid-19 TN Alert
    Covid-19: What Businesses in Tamil Nadu Should Know

    Between March 15 and March 23, 2020, the Government of Tamil Nadu (“GoTN”) issued a few orders and circulars to deal with public health and combating COVID-19, which the businesses, particularly, the manufacturing companies and IT and ITES companies, in Tamil Nadu (“TN”) should know. Key updates are below:

    1. Orders issued under Epidemic Diseases Act

    1.1 On March 15, 2020 the Health and Family Welfare Department of GoTN issued an order for passing TN COVID-19 Regulations. The Regulations have authorised the district collector to take appropriate containment measures including closure of offices or establishments, banning vehicular movement, barring entry and exit of population from the containment area etc. It also imposes certain duties on the hospitals. Read More

  • Tax
    Covid-19: Tax Alert

    On March 24, 2020, the Ministry of Finance, Government of India, announced certain measures to combat the economic impact of the Covid-19 pandemic. These focus at providing relaxations to stakeholders across different sectors and industries in matters of, amongst others, statutory and regulatory compliance. While the central government is yet to issue circulars and/or notifications in this behalf, information regarding these measures can be accessed on the Press Information Bureau’s website: https://pib.gov.in/newsite/erelease.aspx

    This Alert highlights key measures with respect to direct and indirect tax. Read More

  • Litigation
    Covid-19: Impact on Indian Courts

    Amongst other things, Covid-19 outbreak has had a huge impact on Indian courts where it is impossible to control mass gatherings as the volume of people physically present is the very antithesis of what current social distancing norms require. Apart from judges, lawyers, litigants, there is a battery of support staff that provide direct and ancillary services and whose presence is necessary for courts smooth functioning. The need of the hour is for all courts to enforce urgent measures to contain the spread of the coronavirus. Since March 13, 2020 when the affected count in India was 81, Supreme Court of India (“SC”) and various other subordinate courts have issued numerous circulars. Today, with 30 states and UT’s in India under complete lockdown and number of cases over 500, the measures have become more stringent. On March 23, 2020, additional circulars have been issued by various forums encouraging the use of technology to hear urgent matters in order to prevent mass gatherings. Read More

  • Corporate
    MCA initiatives to deal with Covid-19

    Given the COVID-19 crisis, the Ministry of Corporate Affairs (“MCA”) announced certain important initiatives to deal with the public health situation and promote social distancing. Key updates are:

    Board Meetings through video conferencing

    Background:Rule 4 of the Companies (Meetings of Board and its Powers) Amendment Rules, 2020 lists various matters which cannot be approved in a board meeting held through video conferencing and require a physical board meeting. These matters are: (a) approval of annual accounts, (b) approval of the board’s report, (c) approval of prospectus, (d)convening of audit committee meetings for consideration of annual accounts, and (e) approval of matters pertaining to amalgamation, merger, demerger, acquisition and takeover. Read More

  • Corporate
    Appointment of Company Secretaries

    On January 3, 2020, the Ministry of Corporate Affairs (“MCA”) issued the Companies (Appointment and Remuneration of Managerial Personnel) Amendment Rules, 2020 which will come into force from April 1, 2020. By this amendment, the MCA has revised the threshold for appointing whole-time Company Secretaries (“CS”) in private companies.

    Amended Provision

    As per revised Rule 8A, every private company having a paid-up capital of INR 100 million or more has to appoint a whole-time CS. Before the amendment, this limit was INR 50 million. Read More

  • Corporate
    MCA amends provisions with respect to DVRs and ESOPs

    On August 16, 2019, the Ministry of Corporate Affairs (“MCA”) amended the Companies (Share Capital and Debentures) Rules, 2014 (“SCD Rules”) and issued the Companies (Share Capital and Debentures) Amendment Rules, 2019 (“Revised SCD Rules”). This edition of the alert apprises you with the amendments pertaining to issue of shares with differential voting rights (“DVRs”) and Employee Stock Options (“ESOPs”).

    Issue of shares with DVRs

    Rule 4 of the SCD Rules listed various conditions to be met before a company could issue DVRs. These are (a) the Articles of Association should authorize the issue; (b) shareholders’ approval is sought by ordinary resolution; Read More

  • Corporate
    Significant Beneficial Owner

    The Significant Beneficial Ownership Rules, 2019 (“the Rules”) issued by Ministry of Corporate Affairs’ (“MCA”) through its notification dated February 8, 2019. The Rules mandate Indian companies (“Reporting Companies”) to furnish a declaration with the Registrar of Companies (“ROC”) notifying their Significant Beneficial Owner (“SBO”), if any.

    Who is a SBO – As per rule 2(h) of the Rules, SBO is an individual who, acting alone or through one or more persons, holds directly and indirectly, at least 10% of the shares or voting rights in the Reporting Company. Merely having direct shareholding in the Reporting Company shall not make any individual an SBO. Read More

  • Telecom
    OSP Open House Dsicussion with TRAI

    On March 29, 2019, the Telecom Regulatory Authority of India (“TRAI”) released a Consultation Paper on Review of Terms and Conditions for registration of Other Service Providers, which was open for comments and counter-comments upto May 20, 2019 and June 3, 2019, respectively. Thereafter, an open house discussion was conducted on July 15, 2019 at New Delhi, where TRAI granted all attendees a week’s time from July 15 to make additional submissions, if any.

    This alert briefly summarizes key points raised by the stakeholders during the open house. On July 15, 2019, TRAI organized an Open House Discussion (“OHD”) on Consultation Paper on Review of Terms and Conditions for registration of Other Service Providers (“OSPs”) with an aim to rationalize and liberalise the existing terms and conditions. The OHD was attended by multiple stakeholders who shared insightful comments and suggestions while emphasizing the need for a forward-looking OSP regime with focus on ease of doing business. Read More

  • Telecom
    OTT Open House Discussion with TRAI

    Over-the-Top Communication Services (“OTTs”) are service providers which provide information and communication technology services (such as voice, text, audio, or video based communication) without owning or operating a network. Instead, OTT providers rely on the global internet to reach the user, hence going “over-the-top” of a Telecom Service Provider’s (“TSP”) network. On November 12, 2018, the Telecom Regulatory Authority of India (“TRAI”) released a consultation paper for proposed regulation of OTTs, which was open for comments and counter-comments till January 21, 2019. Thereafter, open house discussions were held with multiple stakeholders. The last open house was held in New Delhi on May 20, 2019 for deliberating a possible regulatory framework for OTTs.On May 20, 2019, TRAI conducted its last Open House Discussion on regulatory framework for OTTs. Read More

  • Corporate
    NCLT Second Amendment Rules, 2019

    MCA notified National Company Law Tribunal (Second Amendment) Rules, 2019 on May 8, 2019. By this notification, it has amended rule 84 and prescribed the eligibility norms for filing CAS under Section 245 of the Companies Act, 2013. A CAS is a representative law suit which allows a group of people with common interests and grievances to lodge a complaint or sue the accused party. Section 245 allows members and depositors of a company to file CAS for relief before the National Company Law Tribunal (“NCLT”), in case the company’s affairs are being conducted in a manner prejudicial to its own interests or to the interests of members or depositors. As per the amended rule, CAS can now be filed by Read More

  • Corporate
    Extension for ACTIVE form

    The Ministry of Corporate Affairs (“MCA”) notified the Companies (Registration Offices and Fees) Second Amendment Rules, 2019 and the Companies (Incorporation) Fourth Amendment Rules 2019 effective from April 25, 2019. By these notifications, the MCA has extended the deadline for filing e-form – ACTIVE (form INC – 22A) to June 15, 2019.

    Since the outset, many companies have been experiencing difficulties in filing this form such as auditor’s details not getting prefilled in certain cases, compliance by dormant companies, companies in management disputes and companies having a different financial year. This extension is a big relief since the companies have got more time to comply with this. This is a no-fee form till June 15, 2019, and there will a late fee of INR 10,000 in case of delayed filing. Read More

  • Corporate
    E-Form – Active (Active Company Tagging Identities and Verification)

    On January 21, 2019, the Ministry of Corporate Affairs (“MCA”) notified the Companies (Incorporation) Amendment Rules 2019. Pursuant to this, all companies incorporated on or before December 31, 2017 have to file e-form – ACTIVE (form INC – 22A) by April 25, 2019. The objective is to deter non-compliances and reinforce good governance practices for covered companies. Read More

  • FDI
    FDI in Marketplace Based E-commerce

    The Department of Industrial Policy and Promotion (“DIPP”) has amended the consolidated FDI Policy through Press Note 2 dated December 26, 2018 (“PN 2”). This amendment will come into force from February 01, 2019 and impacts all marketplace based e-commerce entities that are operating in India. The offline brick and mortar retailers had been long lobbying for a level-playing field with the large e-commerce players and it appears that PN 2 is a direct consequence of this. Read More

  • FDI
    RBI’s Single Reporting Form

    The Reserve Bank of India (“RBI”) issued a notification on June 7, 2018 proposing integration of multiple foreign investment reporting formats into a combined online single master form (“SMF”). More specifically, SMF combines reporting forms currently used for issue, transfer, disinvestment of capital instruments, capital contribution, depository receipts, convertible notes, employee stock options and downstream investment. A draft format has been released (accessible here) and the final one is yet to be notified. Once notified, Indian entities (companies, limited liability partnerships and investment vehicles) with foreign investment shall be required to comply with their applicable reporting obligations using SMF. Read More

  • FDI
    DIPP Amends FDI Policy

    The Indian Government is focused on promoting brand “Make in India”. This agenda has manifested into various regulatory and policy reforms which aim to provide an investor friendly ecosystem. Realizing the significant role of FDI in manufacture and technology intensive sectors, the Department of Industrial Policy and Promotion (“DIPP”) through its 12th press note of November 24 (“Press Note 12”) revised the Consolidated FDI Policy, 2015. It amends the approval process, sectoral caps, entry and investment conditions, with the objective of facilitating foreign investment in India. Read More

  • Corporate
    New Companies Act, 2013 – The Cat is Finally Out

    The long awaited new Companies Act, 2013, after a lot of expectations and speculations, was finally notified in the Gazette of India on August 30, 2013. The new law, which is more comprehensive than its predecessor with 470 sections spread over 29 chapters and 7 schedules, replaces the six decade old Companies Act, 1956. The 2013 Act intends to promote self-regulation and introduces novel concepts including one-person company, small company and dormant company. It also promotes investor protection and transparency by including concepts of insider trading, class action suits, creation of a National Financial Reporting Authority and establishment of Serious Fraud Investigation Office for investigation of fraud. Further, a mammoth section 2 containing 94 definitions has been added for better clarity. There are 37 new definitions in the new Act when compared to the 1956 legislation. Read More

  • Competition
    CCI Eases Norms for M&A

    On April 4, 2013, the Competition Commission of India (“CCI”) amended the CCI (Procedure in regard to transaction of business relating to combination) Regulations, 2011 (“Merger Control Regulations”) easing norms for certain M&A activity. Regulation 4 exempts certain transactions from the radar of CCI. These transactions are listed in Schedule I of the Merger Control Regulations and are “ordinarily not likely to cause an appreciable adverse effect on competition in India.” The April 2013 amendment have brought more clarity to Schedule I and will facilitate internal reorganization and restructuring of companies and additional stake acquisition without notifying the CCI. Read More

  • Aviation
    Enlarging the Scope of FDI in Aviation Sector

    The Cabinet Committee of Economic Affairs (“Committee”) on September 14, 2012 approved the proposal of Department of Policy and Promotion (“DIPP”) for permitting foreign airlines to make Foreign Direct Investment (“FDI”) in the aviation sector. Once the proposal is implemented, the prevailing restriction on foreign airlines from investing in the airline business will be removed. Prior to the change in policy, foreign airlines were permitted to invest and participate in equity only in companies operating cargo airlines, helicopter and seaplane services. Read More

  • Retail
    India Welcomes FDI in Multi-Brand Retail

    The much awaited news arrived on a Friday, hopefully, ending a protracted controversy. The Indian Government opened its economy to FDI in multi-brand retail on September 14, 2012, subject to specific conditions. At the end of 2011, the Cabinet had approved a proposal to introduce FDI in this sector which was rolled back due to protests by numerous political parties. Following an exhaustive consultative process with the state governments, the Government has now re-introduced the proposal with certain modifications to increase its acceptability to various stakeholders. Read More

  • Tax
    Mauritius trade route marred?

    In a complete disregard to the decision of the Supreme Court of India (“SC”) in Union of India vs. Azadi Bachao Andolan, (2003) 263 ITR 706, 263 ITR 706 (SC), which had permitted the Mauritian companies having tax residency certificates to benefit from the India-Mauritius tax treaty, Circular No. 789, dated 13-4-2000, the recent decision of the Bombay High Court (“HC”) in E Trade Mauritius Limited vs. ADIT & Ors, WP. No. 2134 of 2008, seriously impacts the Mauritius route. Read More

  • Telecom
    MVNOs Set to Launch Themselves in India

    Recent media reports confirm that the Mobile Virtual Network Operators (“MVNOs”) have been allowed by the Telecom Commission (“Commission”) to launch their operations in India. Though the entry of MVNOs in the Indian market was permitted in 2008 but so far the Department of Telecommunications (“DOT”) has issued no guidelines with regard to their operation. Following this approval by the Commission, DOT is expected to come out with specific guidelines very soon which is bound to attract a lot of MVNOs in the Indian market, one of the fastest growing mobile markets. Read More

  • Corporate
    A Faster Way To Exit

    The Scheme provides an easy route for the defunct companies to make an application to the ROC to remove their names from the ROC register which has not (i) been doing any business activity in the previous financial year, (ii) commenced any business activity since incorporation, or (iii) been identified as dormant by MCA or have an active status. The Scheme, which will come into effect from July 03, 2011, is an improvement over the previous Easy Exit Scheme (EES) and will provide an opportunity to the defunct companies to a fast track exit with minimal compliance. Read More

  • Corporate
    MCA recognizes E-presence in meetings!

    On May 20, 2011, MCA issued two circular (Circulars No. 27 & 28 of 2011) setting out the rules for the participation of the directors and shareholders in the meetings of the company electronically. MCA assessed the legal implications of allowing this practice in view of the provisions of the Information Technology Act, 2000 (“IT Act”) that deals with the legal recognition of the electronic records, dispatch and receipt of electronic information. The procedures provided in the notifications will have to be followed in addition to the existing practice of conducting the meetings with the physical presence of the directors/members as required under the Companies Act, 1956 (“Act”) Generally, board and shareholders’ meetings can be held provided the prescribed quorum is present which requires physical presence at the venue of the meeting, either directly or through alternates/proxies/authorized representatives. However, in the notifications, “electronic mode” alludes to a videoconference facility which will facilitate concurrent communication by all participants. Presence by videoconference will be akin to physical presence and will be counted towards the quorum. There following list of measures must be followed for implementing such electronic meetings. Read More

  • Capital Markets
    New Delisting Regulations For Equity Shares

    The Securities and Exchange Board of India (“SEBI”), issued a notification dated June 10, 2009 on delisting of equity shares from stock markets through the SEBI (Delisting of Equity Shares) Regulations, 2009 (“2009 Regulations”). These Regulations came into force with immediate effect and cover additional grounds from the pre-existing delisting regulations of 2003 (“2003 Regulations”).

    Delisting essentially takes place when the securities of a publicly traded company are removed on account of certain reasons from the stock exchange where they are listed, and are broadly categorized as voluntary or compulsory delisting. The reasons for delisting are very company specific and cannot be generalized. Read More

  • Commercial Law
    Sections of the Competition Act Notified

    The Ministry of Corporate Affairs has finally brought into force the “more” substantive sections of the Competition Act, 2002 (“Act”) (vide notification S.O 1241 (E) and S.O 1242 (E), both dated May 15, 2009) relating to anti-competitive agreements (section 3) and abuse of dominant position (section 4) along with other related and miscellaneous provisions. Almost all the provisions of Act are now notified except a few which still require some more deliberation. Section 5 (combinations) and section 6 (regulation of combinations), for instance, are still not in force.

    Starting May 20, 2009, the Competition Commission of India (“CCI”) can take cognizance of offences and initiate proceedings against the allegedly defaulting party for entering into anti-competitive agreements or for abusing their dominant position. Read More

  • Corporate
    MCA’s Two New Schemes – A golden opportunity for defaulting companies

    It is well-known that numerous companies do not file their documents in a timely manner with the Registrar of Companies (“ROC”).This delay has an adverse effect on those who are engaged in the process of upgrading the electronic records. A natural corollary of such practice is that the so-called “public documents” are not available for inspection by the public who cannot access the records. Taking unprecedented initiative, the Ministry of Corporate Affairs has announced two new schemes aimed at assisting defaulting companies and providing them with an opportunity to make good their defaults in statutory filings with the ROC. Read More

  • Immigration
    After the Visa Storm

    On August 20, 2009 the Department of Industrial Policy and Promotion of the Ministry of Commerce and Industry notified certain guidelines for the issue of business visas (“BVs”) and employment visas (“EVs”) to foreign nationals. Per these guidelines all foreign nationals in India who were on BVs and were engaged in the implementation of projects, were required to leave the country, either upon the expiry of their visas or by October 31, 2009, whichever was earlier, and that no further extension of visas was liable to be granted. Though, ostensibly directed at unskilled Chinese workers to whom an inordinately large number of BVs had been granted by the Indian Embassy and Consulates in the People’s Republic of China, the notification potentially threatened the continued presence of all the foreign expatriates and their dependents. Understandably, the Ministry of Home Affairs (“MHA”) was inundated by the foreign expatriates enquiring whether they were covered under the notification and whether they and their families were required to leave India. It was to address this emergent situation that the MHA on October 30, 2009 issued Frequently Asked Questions (“FAQs”) on “Work related visas issued by India” outlining the categories of those eligible and the conditions subject to which BVs and EVs were to be granted. Read More

  • Regulatory Affairs
    Making FDI Inflows, and M&A More “Secure”

    According to a press report of August 19, 2009, joining a gamut of nations, the Indian government is considering a sweeping review of its FDI guidelines “following increasing risk of terror funds being parked in the country and other investments being fraught with security implications.” Justifying its stance in the name of a fear of terrorism is a new twist. Many countries, including the United States, have protectionist legislation favoring their nationals. As a consequence, the result is often decreased trade flows and an eventual increase in tariff barriers in total contrast to the spirit of the World Trade Organization.  Read More

  • Tax
    Special Economic Zone Developers Breathe a Sigh of Relief

    Superseding the previous notification granting partial relief in service tax, the Ministry of Finance, issued another notification (No. 15/2009 – Service tax, dated May 20, 2009) providing unconditional exemption from service tax to developers and units for services that are consumed within the Special Economic Zone (“SEZ”).

    The earlier notification (No. 9/2009 – Service Tax, dated March 03, 2009) provided that SEZ developers can claim refund for the service tax paid with respect to all authorized input services, irrespective of whether these services were consumed inside or outside the SEZ, as long as these services were used in relation to the authorized operations in the SEZ. This implied that all developers and units in the SEZ had to pay tax on the services consumed by them and thereafter apply for a refund from the tax authorities. Read More

  • Tax
    No Service Tax – A Good Service

    The Delhi High Court (“DHC”), in its recent judgment of Home Solution Retail India Ltd. & Others vs. Union of India, has given a huge respite to companies, realtors, retailers and firms who run their businesses from rented immovable property. The Ministry of Finance, Department of Revenue had issued a notification no. 24/2007 dated May 22, 2007 (“Notification”) and circular no. 98/1/2008-ST dated January 04, 2008 (“Circular”), subsequent to which the lease of any commercial space attracted service tax @ 12 % approximately of the total monthly rent. However, following the DHC’s judgment of April 18, 2009, no service tax will be levied on the renting of any immovable property. This decision has been welcomed by all, especially in today’s recessionary financial climate where “a penny saved is a penny earned.” Read More

  • Tax
    Lower Capital Gains for Foreign Companies from any Securities Transaction

    While giving its ruling in an application filed by Fujitsu Services Limited, the Authority of Advanced Rulings (“AAR”) held that foreign companies transferring shares of a listed company can claim benefit of a lower rate of tax on capital gains arising from the transaction.

    Facts of the case:

    Fujitsu Services Limited (“Fujitsu”), a company incorporated in United Kingdom had acquired shares of an Indian company Zensar Technologies Limited (“Zensar”) constituting 26.55% of the share capital of Zensar and such shares were held for over 12 months. These shares were listed on the National Stock Exchange and the Bombay Stock Exchange. On July 04, 2007, Fujitsu sold its entire shareholding to Jubilee Investments and Industries Limited (“Jubilee”), an Indian company and Pedriano Investments Limited (“Pedriano”), a Cyprus company. Jubilee and Pedriano deducted tax from the sale consideration @ 20% but Fujitsu contended that tax ought to be deducted at 10%, the rate applicable to long term capital gain (“LTCG”). Read More

FLASH

  • Food & Pharma
    Major Relief for Alcohol Market Players

    The Regulations mandate that regular beer or lager should be free of yeast while in draught beer the maximum yeast count must not exceed 40 CFU (colony-forming units). The Regulations do not put craft beer in a separate category which, generally have yeast content as high as 3 million CFU. As a result, craft brewers, who were in a state of dilemma expressed their difficulty before the regulator in implementation of these limits, and therefore, through the April 2 notification, FSSAI announced that the Regulations shall be effective minus the parameter for yeast in various categories of beer. Further, the Regulations also prescribed that from April 1, 2019 all liquor bottles shall carry cautionary messages, in capital letters, stating “Drinking is injurious to health” and “Don’t Drink and Drive” on their labels, in font size which is minimum 3 mm. Again, the stakeholders who have already invested in labels which do not contain these messages sought time from the regulator to implement this. As a result, the mandate was relaxed through the April 2 notification and alcoholic beverages which are manufactured prior to April 1, 2019 are now allowed to be sold with old labels until March 31, 2020. Further, size of the cautionary message has been relaxed to 1.5 mm in case of alcoholic beverage bottles of up to 200 ml but for bottles larger than 200 ml, the mandate of 3 mm stays as is. Read More

  • Corporate Laws
    E-form AGILE gets added to e-form SPICe

    Application for incorporation of a company, i.e. SPICe is now linked with e-form AGILE (INC-35). AGILE enables applicants to procure GSTIN, EPFO and ESIC registrations through a single application. It is not mandatory though, for the applicants to obtain these registrations at the time of incorporation. Vis-a-vis GST registration, it can be obtained only for the proposed company’s principal place of business. The form cannot be used in isolation to procure any or all of the three registrations. Also, MCA does not levy any additional fee for AGILE filing. Read More

  • Food & Pharma
    No GST on freebies

    It is a common practice among certain pharmaceutical companies to provide drug samples to their stockists, dealers, medical practitioners, etc. free of cost. So, a medicine strip with a free medical planner or 20% extra for the same price, would face a levy on the combined value and in case two products face different rates of GST, the product with the higher levy would determine tax rate of the product. The Ministry has now clarified with the Circular that since “supply” under section 7 of the Central Goods and Services Tax Act, 2017 includes all forms of supply of goods or services such as sale, transfer, barter, exchange, licence, rental, lease or disposal made for a consideration by a person in the course of furtherance of business and free samples and discounts are not for consideration, no GST shall be levied on them. However, this is inapplicable if the activity falls within the ambit of Schedule I of the said Act. Read More

  • Corporate Laws
    SEBI tightens the noose on corporate governance further and mandates annual secretarial audit

    Section 204 of the Companies Act mandates annual secretarial audit for listed companies, public companies having a paid-up share capital of fifty crores or more or turnover of two hundred fifty crores or more. The Circular, while reiterating this mandate for listed companies extends its application and brings their material unlisted Indian subsidiaries too within the ambit. Material subsidiaries, as the SEBI (Listing Obligations and Disclosure Requirements) Regulations define are those subsidiaries whose income or net worth exceeds twenty percent of the consolidated income or net worth respectively, of the listed company and its subsidiaries, in the immediately preceding accounting year. The secretarial audit has to be conducted by a practicing company secretary and the audit report has to be filed before the concerned stock exchange latest by May 30, every year. The Circular shall be effective this year on March 31, 2019. Read More

  • Food & Pharma
    Medical Council of India to make way for National Medical Commission

    Ever since April 2010, when the MCI chief Ketan Desai was arrested for demanding bribe and the Delhi High Court terming MCI as “den of corruption”, the need for more stringent laws has been felt. A Committee was set up in 2016, under the NITI Aayog to review the Medical Council Act, 1956 which recommended changes in the current system regulated by the Medical Council. The Bill has adopted most of the recommendations of the Aayog and it appears that the need for stringent laws will soon be aptly catered. Key highlights of the Bill are-

    • Taking cue from the principle of separation of powers, the Bill will establish National Medical Commission (“NMC”) which would be an umbrella body for supervision of medical education and practice. It will have four segregated autonomous verticals under it to look at: (i) under-graduate medical education, (ii) post-graduate medical education, (iii) accreditation of medical institutions, and (iv) registration of doctors and their conduct. The NMC will have 25 members who would not necessarily be medical practitioners. A Search Committee will be constituted to recommend names for the post of Chairperson and members for the NMC. Term of NMC’s members will be a maximum of four years, with no reappointment. Read More
  • Corporate Laws
    MCA mandates disclosure of payments due to MSEs

    Chapter V of the  Micro, Small and Medium Enterprises Development Act, 2006 mandates buyers who procure goods or services from MSEs to make payments not later than 45 days from the date of acceptance of such goods or services. In case the buyer defaults in making payments within the prescribed timelines, then the buyer becomes liable to pay the outstanding amount with compound interest, on monthly basis, at thrice the rate notified by the Reserve Bank of India. MCA’s notification dated January 22, 2018 is a step further in the direction of ensuring of timely payments. The notification mandates half yearly disclosure of outstanding payments towards goods or services procured from MSEs. The disclosure is to be done before the MCA in e-form MSME Form I. Due date for filing of this form for the period from April to September is October 31 and from October to March is April 30. As per the notification, the due date for filing first return is February 21, 2019, however, as the MCA has not issued the form yet, the due date should be extended. Form requires buyers to furnish reasons for delay in honoring payments. Non-filing of the form or providing incorrect information in the form calls for penalties. While the defaulting company will be liable to pay up to INR 25,000, the defaulting officer will be liable for imprisonment up to 6 months or fine up to INR 300,000 or both. Read More

  • Commercial Law
    Amendments to the Specific Relief Act, 1963

    Previously, Indian courts would exercise their discretion in granting specific performance of contracts by non-performing parties by applying principles enshrined in the un-amended Act. However, with the recent amendments the old section 10 has been substituted with a new section, which makes it unambiguous that courts shall now have limited discretion in decreeing specific performance of a contract, which “shall be granted” subject to limitations prescribed in sections 11(2), 14 or 16 of the Act. Accordingly, specific performance of a contract is now the rule rather than exception. Further, section 11 of the Act concerning private trusts has also been amended to replace the words “contract may, in the discretion of the court” with “contract shall” thereby clarifying the renewed legislative intent. Read More

  • Real Estate
    Definition of Carpet Area & its Interpretation

    Typically, carpet area would mean such area of an apartment that could actually be used by the occupier of the premises. Until RERA, there was no statutory definition of “carpet area”. Of course, the vacuum meant that developers would generally include areas such as shafts, lift-wells, etc. within carpet area, which were not usable by an apartment owner. Section 2(k) of RERA defines carpet area as the “net usable area of an apartment excluding the area covered by external walls, areas under services shafts, exclusive balcony… area…but includes the areas covered by the internal partition walls of the apartment.” Cometh July 2018, the National Commission has awarded compensation to an apartment owner on the basis that internal and external walls of the apartment and area under respective door jams shall not be part of carpet area of the apartment, and because the developer had included them in carpet area, it was held liable for deficiency in carpet areaRead More

  • Competition Law
    Second verdict by CCI under the Leniency Regulations

    On April 19, 2018, CCI entertained an application for leniency filed by Panasonic Energy India Company Ltd. (“Panasonic”, part of Panasonic Corporation, Japan) in a matter where Panasonic plead for lesser penalty whilst disclosing that it was operating a cartel along with Eveready Industries India Ltd. (“Eveready”) and Indo National Limited (“Nippo”) concerning manipulation and/or distortion of production, price, sale, supply and distribution of zinc-carbon dry batteries sold by them, which was a mutually beneficial arrangement for the entities. It is pertinent to note that even the managerial personnel of the aforesaid entities were directly instrumental in achieving cartelisation. It is also noteworthy that the Association of Indian Dry Cell Manufacturers (“AIDCM”) was an active participant to the cartel and its activities. Accordingly, penalties were also imposed on the said personnel and the AIDCM. CCI accorded 100% reduction in the penalty imposed under the Act in case of Panasonic, as it was the first entity to approach the CCI and had made full disclosure of all incriminating facts, and cooperated with the CCI expeditiously thereby facilitating efficient resolution of the contravention. Eveready and Nippo approached the CCI thereafter, i.e. after Panasonic had already approached the CCI and were granted 30% and 20% reduction in penalties, respectively. Read More

  • Dispute Resolution
    Moratorium under IBC to cover personal guarantees of promoters furnished to financial creditors 

    Recently, NCLAT faced a situation in State Bank of India v. Mr. V. Ramakrishnan and Ors. [Company Appeal (AT) Insolvency no. 213 of 2017], where the State Bank of India had appealed against an order of the National Company Law Tribunal (“NCLT”), Chennai, which prevented it from invoking the personal guarantee of a promoter of a corporate debtor while the latter had declared bankruptcy under the IBC. The promoter had given such guarantee in order to obtain certain credit facilities for the corporate debtor. The NCLT held that once a moratorium has been declared under section 14 of the IBC, such guarantees cannot be invoked by a financial creditor. Further, NCLAT dismissed the appeal before it and reiterated the position enunciated by the NCLT, Chennai. It observed that a moratorium under IBC not only prohibited legal proceedings against assets of a corporate debtor, but reasoned that since a resolution plan approved by a committee of creditors under Section 31 of IBC is binding on the corporate debtor and, its employees, members, creditors, guarantors, and other stakeholders involved in the plan, a moratorium would also extend to the guarantor. In other words, NCLAT agreed with NCLT Chennai in holding that the moratorium will extend to the personal guarantor thereby preventing recourse to invocation of such guarantees by a financial creditor whilst the corporate debtor is in the midst of bankruptcy. Read More

  • Competition Law
    Requirement of notice for acquisition of company facing proceedings under IBC

    Section 6 of the CA mandates that an enterprise intending an acquisition covered under section 5 of the CA, must give a notice to the Competition Commission of India (“CCI”) seeking its approval of the acquisition to the extent that such acquisition shall not cause and is not likely to cause an appreciable adverse effect on competition within the relevant market in India. Failure to furnish such notice to the CCI has repercussions under section 43A of the CA, which may extend to a penalty of 1% of the total turnover or assets, whichever is higher. Section 6 requires that in case of an acquisition, such notice shall be given within 30 days of “execution of any agreement or other document” concerning acquisition. Though the 30 day requirement has been done away with until June 28, 2022, vide an exemption notification of the Ministry of Corporate Affairs dated June 29, 2017, necessity of furnishing the notice and consequences of non-compliance remain intact. Recently, in 2 separate bids for acquisition of Binani Cements Limited (that is facing bankruptcy proceedings before the National Company Law Tribunal under the IBC) by Ultratech Cement Ltd. and the Rajputana Properties (a subsidiary of Dalmia Bharat Limited), respectively, this issue came up once again, i.e. what is the trigger event for furnishing a section 6 notice to the CCI in such cases where the target is in the midst of bankruptcy proceedings? News reports confirmed that both bidders had already filed such section 6 notices, and Rajputana Properties had, in fact, also obtained the CCI’s approval within 13 days only. Read More

  • Real Estate
    Registration of Joint Development Arrangements under RERA

    RERA applies to all real estate projects, i.e. both residential as well as commercial projects irrespective of whether these are in the nature of building projects, or plotted development by a developer provided that (a) the land area of the project exceeds 500 sq. mtrs. or, (b) in case of a building project, the number of apartments to be constructed exceed eight, and a completion certificate is yet to be obtained for the project at the time of commencement of the relative provisions of RERA, i.e. as on May 1, 2017. Accordingly, the developer of a project covered under RERA, as above, shall register the said project with the concerned authority as mandated by section 3 of RERA. This raises the question as to whether, nowadays commonly executed, property owner and developer joint development or collaboration agreements would also be covered under RERA’s ambit, if the aforesaid conditions are met. Read More

  • Food & Pharma
    No DCGI approval required for clinical trials for academic purposes

    The Ministry of Health and Family Welfare, vide its notification No. G.S.R. 313(E) dated March 16, 2016, amended Rule 122DA of the Rules to segregate procedures of approval for clinical trials of drugs intended for academic and marketing purposes. As per the amended Rule 122DA, no permission is required to conduct clinical trials for academic research on drug formulations approved by the Ethics Committee. This exception covers clinical trials for new indications, routes of administration, dose or dosage forms of drugs. Prior to this amendment, researchers had to seek approval from DCGI for clinical trials for academic purposes, in the same manner as pharmaceutical companies’ application for approval of new drugs. It included many stages and clearance from multiple committees, and hence delayed research and development activities related to drugs developed for treatment of cancer and other such critical medical conditions. Read More

  • Food & Pharma
    NPPA clarifies implementation of prices fixed under DPCO 2013

    The NPPA has recently issued an office memorandum to clarify the doubts raised by manufacturers and retailers regarding implementation of prices of drugs revised in accordance with the DPCO from time to time. Para 24 of the DPCO requires manufacturers to comply with the revised prices notified under the DPCO with immediate effect from the date of notification by issuing a revised/supplementary price list to the retailers and dealers. The office memorandum issued by the NPPA on April 13, 2016 allows manufacturers to circulate the revised/supplementary price list to the dealers and retailers by means of e-mail, WhatsApp, etc. to save time and submit the price list online on the NPPA website as proof thereof. The office memorandum also clarifies that re-calling/re-labelling/re-stickering of pre-manufactured batches of drugs is not mandatory to implement the revised prices. However, if the manufacturers choose to do so, they are advised to do it in a phased manner so that it does not cause excessive shortage of the concerned drugs in the market. Read More

  • Food & Pharma
    FSSAI launches new mobile application

    The FSSAI has launched a new mobile application (“App”) which allows food business operators to check their compliance and allows customers to raise complaints regarding food safety. This App is available on android platform, with built-in geolocation function which allows all android device users to automatically detect their location. While food business operators (“FBOs”) can use this for registration and to check compliance of multiple outlets, customers can use the same to file complaints regarding quality of packaged food and ready-to-eat food served in outlets along with photos. The App also allows FBOs to use the food safety inspection tool to either self-check compliance or seek expert inspection and generate automated reports for multiple locations. At the same time it also has provision for the customers to enter the license/registration number of the FBO to submit information about manufacturing date, expiry date and general adherence to food safety standards by any food business operator. The customer is also given the option of rating the overall hygiene of the food serving establishment. The App also provides access to regular updates about new FSSAI guidelines and directives along with webinars for online training in license/registration process, packaging and labeling and food product approval to help FBOs as well as customers understand the regulatory parameters better. Read More

  • Food & Pharma
    Online registrations and license for import of medical devices will be possible

    We all know that registration certificates and import license for drugs can be procured by click of a mouse through SUGAM. However, there is no such facility for medical devices. With foreign players coming in the sector, the facility to get registration and licensing related paperwork of import of medical devices via an online system was much awaited. CDSCO is planning to launch a web portal for licensing the import of medical device from March, under SUGAM, an online solution for submission, application and grant of permission for the import of drugs, in compliance with Union health ministry’s initiative of e-governance. Once a system is in place, the users such as, drug importers, Indian agents, corporates, foreign enterprises holding Indian subsidiaries and manufacturing units, will not only get to apply for licenses online, they will also get an option to track the status of their applications online through an application reference number provided by the system during the submission of application. Read More

  • Food & Pharma
    Validity of license to manufacture/import drugs for examination, test and analysis increased to 3 years

    DTAB has recently approved a recommendation to increase the validity of the license to import drugs for test and analysis under Form 11 and license to manufacture drugs for test and analysis under Form 29 from one year to three years. The Drugs and Cosmetics Rules, 1945 (“Rules”) permit the manufacture as well as the import of small quantities of drugs for test and analysis purposes, which is otherwise prohibited under the Drugs and Cosmetics Act. The validity period of such licenses was one year from the date of issue.

    This move has come in light of concerns raised by various drug manufacturers associations regarding the hassle of seeking a fresh license every year, to import drugs for the purpose of clinical trials and drug development. The department of commerce has also made similar recommendations to the health ministry in order to aid the business of such drug manufacturers. Read More

  • Food & Pharma
    DCGI’s proposal to amend pharma manufacturing laws

    DCGI has proposed to amend Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945 to bring the domestic drug manufacturing standards in line with those recommended by the World Health Organization (“WHO”). As per the WHO’s website, good manufacturing practices includes factors such as sanitation and hygiene, qualification and validation, self-inspection, quality audits, suppliers’ audits, prevention of cross-contamination and bacterial contamination during production, training of employees and personal hygiene. According to DCGI, a technical advisory board will be set up to recommend the proposed changes to the existing law. This amendment is sought to be brought about within the next six months. Read More

  • Food & Pharma
    DCGI’s sub-committee to frame guidelines on regulation of online pharmacies

    With the recent surge in e-commerce permeating into the drugs and pharmaceutical industry, state food and drugs administration (“FDA”) authorities are frowning upon online pharmacies. The Maharashtra FDA had initiated action against online marketplaces like SnapDeal and Amazon while the Gujarat FDA too had registered a case against certain online pharmacies. Realizing the need for constituting guidelines for online pharmacies, the DGCI has formed a sub-committee under the chairmanship of Harshadeep Kamble, Commissioner Food and Drug’s Administration & Food Safety Commissioner, Maharashtra, to assess the feasibility of online pharmacies. The sub-committee is also in consultation with state drug controllers, trade bodies, pharmacy chains, e-tailers, states chemists and druggists associations, and consumer forums. The sub-committee is seeking to allow online sale of drugs while putting in place additional safeguards for pharmacy licensing and sale of over the counter drugs, and recognition of electronic record of prescriptions in terms of the Rules. Read More

  • Food & Pharma
    FSSAI issues regulations specifying permissible limits of toxins in food

    The FSSAI has issued a draft notification to amend the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011. The proposed amendment specifies the permissible levels of toxic metal contaminants including lead, arsenic, tin and cadmium in food items by introducing the following entries against each metal toxin/contaminant proposed to be regulated under the said regulations:

    • Lead – Various fruits and vegetables (including assorted subtropical, bulb, leafy and legume vegetables), pulses, canned fruits and vegetables, jam, mango chutney, table olives, pickled cucumber, processed tomato concentrates, fruit juices, cereal grains, meat of cattle, sheep and pig (including fat from such meat)
    • Arsenic – Margarine, minarine, named animal fats, mineral water, fish and crustaceans, molluscs, salt, vegetable oil, olive oil, edible fats and oils

    Read More

  • Food & Pharma
    Supreme Court directs the Department of Pharmaceuticals to revise the National Pharmaceutical Pricing Policy and the Drugs Price Control Order 2013

    Under the Drug Price Control Order 2013 (“DPCO”), the Government controls prices of 348 drugs listed in the National List of Essential Medicines. In a PIL filed by an NGO, All India Drug Action Network (“AIDAN”) it was alleged that the regulation of prices under the DPCO has actually resulted in rendering medicines costlier for the consumer, contrary to the National Pharmaceutical Pricing Policy (“NPPP”) which aims to make medicines affordable for the people. AIDAN also sought inclusion of more life-saving medicines for diseases like diabetes and tuberculosis in the list of drugs whose prices would be regulated by the Government, and to extend the price control to various dosages, strength and combinations. The Court observed that the existing prices charged by pharmaceutical companies in certain states was up to 5000 times their production cost, which when taken into account to determine the average market based price under the DPCO rendered such average even higher than the price charged by the market leader for such medicines. The Court, however, expressed reluctance to delve further into what it termed as a “policy matter” and has asked AIDAN to make representation to the Department of Pharmaceuticals under the Union Ministry of Chemicals and Fertilizers within six weeks and asked the Department to respond to the same within six months thereafter. Read More

  • Technology, Media & Telecom
    Introduction of Virtual Network Operators (VNOs)

    VNO are entities that do not own telecom infrastructure but provide telecom services. TRAI has recommended a licensing framework for the introduction of VNO in telecom sector. Such entry will be facilitated via a mutual agreement of VNO with network operators. It shall be permitted for all services notified in unified licensing with the initial duration of license fixed for a period of 10 years further extendable up to 10 years. TRAI recommended that there will be no infrastructure required, no performance bank guarantee required and terms and conditions of sharing infrastructure shall be left to mutually agreed terms between VNO and network operators. Presently, there is no restriction on the number of VNO patented by one Network operator.

    PSA view – Introduction of VNO comes as a great opportunity for small technology companies and mobile application developers and will be viewed as a step further towards advancement. Read More

  • Food & Pharma
    New National Medical Device Policy mandates separate price control for medical devices

    After all the complaints of overpricing of medical devices like cardiac stents and implants, the government has finally come up with separate price control regime for medical devices. The new draft National Medical Device Policy-2015, issued recently by the Department of Pharmaceuticals (DoP) mandates a separate price control for medical devices. As per the new draft policy, the medical devices will be included as separate entry in the list of commodities controlled under the Essential Commodities Act. The government will announce a separate policy enunciating the principles for regulating the prices of identified medical devices and implement the same by notifying a separate Medical Devices Prices Control Order (MDPCO). Under the new draft policy, a separate division will be created in National Pharmaceuticals Pricing Authority (NPPA) for pricing of the devices by suitably amending the resolution constituting NPPA. At present, prices of medicines are notified through the Drug Prices Control Order, by the department of pharmaceuticals. The draft policy, which has been put up on the department of pharmaceuticals (DoP) website and communicated to industry bodies and chambers, seeks comments within six weeks, after which a final note will be prepared for Cabinet approval. Read More

  • Food & Pharma
    Neutraceuticals guidelines in the pipeline

    These days, the demand for special food items like neutratceuticals and dietary supplements has increasingly been growing by leaps and bounds. The FSSAI had recently constituted Task Force to device a regulatory  framework for regulating supply of these products in the market. Task Force’s recommendations primarily comprise guidelines for the approval of dietary  supplements and neutraceuticals that are manufactured and marketed across the country. Once the recommendations get a nod from the FSSAI, all the manufacturers across the country will have to seek NOC from the  Centre prior to manufacturing neutraceuticals. Read More

  • Technology, Media & Telecom
    Pan-India Mobile Number Portability: “One nation, One number”

    The Government decided to implement inter-service area mobile number portability. In this context, Telecom Regulatory Authority of India (“TRAI”) brought out the Telecommunication Mobile Number Portability (Sixth Amendment), 2015 on January 23, 2015 seeking comments of stakeholders for facilitating full MNP. Primarily, necessary amendments to the MNP service license were issued by DoT wherein it was stated that it would be implemented in the country within six months from the said amendment. In addition, DOT has incorporated the following in the amendment:

    • There is a reduction in timelines for number return process i.e. under the old regulations, after disconnection of the mobile network, the number had to be returned to the number range holder within ninety days. This time period now stands reduced to 60 days. Read More
  • Food & Pharma
    Schedule Y of the Rules to go under knife!

    The clinical trial on new drugs is regulated under the provision of D&C rule 1945 as amended from time to time. The rule provides that no clinical trial can be initiated without the grant of permission by the licensing authority and the condition prescribed there in. The detailed requirements and guidelines for undertaking the clinical trial are specified under schedule Y of said rule. Similarly, for import/manufacture of new drugs, the Union Health Ministry will soon amend the Note regarding the authenticity of the data or documents to be submitted by the applicant under Schedule Y of the Drugs and Cosmetics Rules, 1945 (“Note”). The Note shall provide that only authentic data should be submitted in the application for permission to import and/or manufacture new drugs for sale or to undertake clinical trials. The data will have to be self certified. Note will also provide that the licensing authority reserves the right to reject any data or any document(s) if such data or content of such document are found to be of doubtful integrity. Read More

  • Technology, Media & Telecom
    Communications Convergence Bill, 2014 (“Bill”)

    The Bill seeks to replace the existing telecom laws in India namely the Indian Telegraph Act, 1885, the Indian Wireless Telegraphy Act, 1933, the Telegraph Wires (unlawful possession) Act, 1950, and the Telecom Regulatory Authority of India Act (“TRAI”) of 1997 and bring modification to laws pertaining to Cable TV Networks (Regulation) Act, 1995 and Information Technology Act, 2000. Further, under the Bill a singular commission called the Communication Commission of India will be formed in place of TRAI and Telecom Disputes Settlement and Appellate Tribunal (TDSAT) which will overlook all communication infrastructures. It will consist of seven members. Each member would be a domain expert on areas such as telecom, broadcasting, information technology, law and consumer affairs and finance. Its mandate would be to stimulate market competition in order to ensure better quality services for the consumer and prevent monopolies and take up certain powers of the Censor Board, Ministry Of Environment and Competition Commission of India. This will directly try to regulate the content as well as the carriers who distribute that content. Read More

  • Food & Pharma
    DTAB proposes to waive local drug trials for new drugs

    The DTAB, the apex drug safety authority, has proposed amendment to the D&C Rules to permit exemption for New Drugs already marketed in well-regulated countries like United States of America, European Union etc. through credible PMS mechanism, from local clinical trials in India. As a result, the existing requirement under D&C Rules to conduct Phase III clinical trial for the new drugs approved in other countries stand modified. Further, DTAB has opined that the experts in the specific therapeutic area must evaluate the safety, efficiency and efficacy of the new drugs. Read More

  • Food & Pharma
    WHO issues draft guidelines on Good Pharmacopoeial Practices

    The WHO has issued draft guidelines on Good Pharmacopoeial Practices and is looking for the industry to comment before March 10, 2015. This move by WHO is being appreciated widely. Pharmacopoeias are embedded in almost every country’s national or regional regulatory environment. The Indian Pharmacopoeia (“IP”) is published in fulfillment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder. Also, in several other Indian laws, the IP is recognized as the standard book. A first initiative to reopen the discussion on international harmonization of quality control specifications on a global scale was taken in a side meeting of the 10th International Conference of Drug Regulatory Authorities (“ICDRA”) entitled: ‘Pharmacopoeial Specifications – Need for a Worldwide Approach?’ in Hong Kong in June 2002. This further led to discussions among regulators during the 11th  ICDRA meeting held in Madrid in 2004. Read More

  • Food & Pharma
    Separate drug controller under Ayush ministry on the cards

    Department of Indian Systems of Medicine and Homoeopathy (ISM&H) which was created in March, 1995 and re-named as Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (“AYUSH”) in November, 2003 was constituted with a view to providing focused attention to development of Education & Research in Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy systems. The Department will soon witness upgradation on the regulatory front. We already know that the new government had done a laudable job with the creation of a separate portfolio for AYUSH. Now, the Union Ministry is proposing to have a drug controller at the Centre for AYUSH. This will put in place a separate regulatory regime for Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy which were till now governed by the drug controller of modern medicine. It has been reported that the budgetry allocations for Ayush which were until now very meagre at about Rs. 400 crore for fiscal 2014-15 will soon be elevated to Rs. 2,700 crore for the next fiscal, beginning April 2015. Read More

    • Technology, Media & Telecom
      New Penalty Norms For Unified Access Service Providers in the Pipeline

      Per the unified license agreement, the maximum penalty for violation of any term and condition of the unified license is INR 500 million exclusive of liquidated damages. It has been observed that DoT usually imposes penalties disproportionate to the violations. As a result of the heavy criticism within the industry, DoT will notify new penalty norms which are expected to be enforced by the end of February 2015. The Telecom Commission has approved a graded system of imposition of penalties. As part of the new penalty system, factors such as the seriousness of the violation and its impact on the industry, the policy environment, the government exchequer, customer and national security will be taken into consideration while deciding the penalty. The penalties have been categorized in the following categories i.e. fine of INR 100,000 will be imposed in case of warning, INR 10 million for a minor breach, INR 50 million for moderate breach, INR 200 million for major breach and INR 500 million for severe offences. Read More

    • Food & Pharma
      DHR launches scheme to create trained personnel for patient management & public health

      Department of Health Research (DHR) created under the Ministry of Health & Family Welfare is doing a laudable job with launching scheme called  Human Resources Development for Health Research’ to train human resource for carrying out research activities for improving patient management and public health in the country. Through the scheme the department aims to impart advanced training to medical and health research personnel in India and abroad.

      The main aim of the scheme is to provide advanced training in cutting edge research areas concerning medicine and health for training in India and abroad and to encourage trained manpower to carry out research activities and manage patients in the medical colleges across the country. The scheme is also aimed to increase the overall availability of trained personnel for health research from medical colleges across the country through scholarships, fellowships and career advancement scheme etc. Additionally, the scheme will focus on the creation of a cadre of trained medical/health researchers in specific identified priority areas of health research such as clinical trials, toxicology, good clinical practices, good laboratory practices, clinical psychology, biotechnology, drugs chemistry etc. Read More

    • Technology, Media & Telecom
      Jurisdiction of e-commerce cases ubiquitous

      In a recent decision in the case of World Wrestling Entertainment Inc vs. M/S Reshma Collections, the Delhi High Court held that jurisdiction in e-commerce cases involving trade mark and copyright disputes would be determined by the buyer’s place of residence. While reaching this conclusion, the court interpreted the meaning of the phrase “carries on business” from section 134(2) of the Trade Marks Act and section 62(2) of the Copyright Act. Read More

    • Food & Pharma
      DoP for setting up VC fund for R&D in pharmaceuticals

      The government would initially allocate Rs.500 crore between all the pharma funds to be set up under this project. Each fund would then be expected to invest (i) at least Rs.150 crore or more and (ii) 4 times of investment sought from the government. The project sets out the manner in which fund will be established and managed, the roles of key stakeholders and estimated event schedules and timelines.

      The government would act as an investor whose contribution would be managed by the fund manager in terms of the contribution agreement between them and the trustee. The funds will be provided as a financing solution for high-risk, potentially high-reward projects that, due to the lack of substantial tangible assets, expected years of negative earnings, and uncertain prospects, are unable to raise funding from more traditional sources like banks or capital markets. Like pharma R&D, where the fund would promote entrepreneurship and support the development of a self-sustaining environment. Read More

    • Technology, Media & Telecom
      MIB advisory to broadcasters

      ASCI had issued guidelines dated August 14, 2014 regarding advertising for skin lightening or fairness improvement products stating that no advertisement should communicate any discrimination and reinforce negative social stereotyping on the basis of skin color. But TV channels continue showing such ads. ASCI, therefore, made a compliant before MIB regarding various TV channels carrying objectionable advertisements in violation of the ASCI Code, the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954, the Cable Television Networks (Regulation) Act, 1995 and Cable Television Network Rules 1994 (“Cable TV Rules”). MIB’s Inter-Ministerial Committee observed that non-compliance of ASCI’s decision violates Rule 7(9) of the Cable TV Rules which provides that advertisements that violate the Advertising Code should not be carried in the cable service and advised all TV channels to refrain from carrying advertisements of products in violation of the aforesaid rules. Read More

  • Food & Pharma
    IPC launched AER reporting form and guidance document

    The AER reporting form was launched during a national level conference that was held in Delhi to sensitize the patients about the ADRs and the immense importance in participating in Pharmacovigilance Program of India (“PvPI”) program directly. This form will be available on pilot basis in 150 ADR centres and will help in understanding whether patients are comfortable with the form for reporting of ADRs in future. The IPC, which acts as the national coordination centre (“NCC”) for the program plans to pan it across on an active manner for better success of this initiative. The current version of consumer reporting form is available in English version; however NCC has already started converting the same into Hindi and several regional languages. In addition, based on the recommendations of WHO-NRA assessment, the IPC released a guidance document during the 47th Drug Consultative Committee meeting in Delhi which will act as a point of reference to ensure best practices with respect to ADRs, to help streamline the process in a uniform manner. Read More

  • Technology, Media & Telecom
    TRAI reduces ceiling tariffs for Domestic Leased Circuits (“DLCs”)

    Press release no. 38/2014 dated July 14, 2014 issued by TRAI reduced the ceiling tariffs for Point-to-Point Domestic Leased Circuits (“P2P-DLCs”) by 60 % and has brought DLCs of STM-4 (622 Mbps) capacity under tariff regulation. The new tariff regime came into effect from August 1, 2014. The DLCs form crucial building blocks for the delivery of various services like e-commerce, e-governance, internet access for the masses and knowledge based industries like business process outsourcing, IT and ITES. The tariffs for P2P-DLCs have been regulated in the form of ceiling tariffs on the basis of capacity and distance. They were last revised in the year 2005. The present exercise to review tariffs for DLCs was initiated by TRAI in the context of decline in per unit costs of providing DLCs due to (i) increase in demand, (ii) increase in transmission infrastructure, and (iii) increase in the bandwidth carrying capacity of transmission media, and signs of lack of competition in some parts of the country. Read More

  • Food & Pharma
    NPPA issues guidelines for stoppage of scheduled formulations

    NPPA has issued draft guidelines for the disposal of Form-IV application under paragraph 21(2) of DPCO 2013 for discontinuation of scheduled formulations from the market by the pharmaceutical companies. In the draft guidelines, paragraph 21(2) provides that any manufacturer of scheduled formulation, intending to discontinue any scheduled formulation from the market shall (i) issue a public notice and also (ii) intimate the government in Form-IV of this order in this regard at least six month prior to the intended date of discontinuation and (iii) the government may, in public interest, direct the manufacturer of the scheduled formulation to continue with the required level of production or import for a period not exceeding one year, from the intended date of such discontinuation within a period of a 60 days of receipt of such intimation. As per the guidelines, permission for discontinuation may be granted by the NPPA wherever number of market players are 10 or more and the market share of the applicant company is <1%. Permission may also be granted by the NPPA for gradual discontinuation and the applicant company may be advised within a period of 60 days from the receipt of Form-IV to continue to manufacture/import and sale the drug during the next six months, wherever number of market players are 10 or more and the market share of the applicant company is 1%-3%. The guidelines further say that permission may be granted by the NPPA for gradual discontinuation and the applicant company may be advised within a period of 60 days from the receipt of Form-IV to continue manufacture/import and sale the drug during the next 12 months, wherever the number of market players are more than 5 and less than 10 and the market share of the applicant company is >3%-<5%. The company intending to discontinue the scheduled formulation from the market shall also issue a public notice. Permission for discontinuation may be granted by the NPPA only after approval of the Authority where number of market players are less than 5 and the applicant company holds 5%/< of market share. In this regard, an agenda note should be put up for consideration of the Authority within one month of the receipt of Form-IV application. Read More

  • Technology, Media & Telecom
    Broadband internet a basic right in the new National Broadband Policy!

    The Policy aims to include broadband in the list of basic necessities in the new legislation of “Right to Broadband.” Telecom Regulatory Authority of India had started a consultation process in this regard and for setting a minimum download speed of 1 Mbps for 3G connections and 56Kbps for 2G connections. The definition of “broadband” was changed to refer to connections with speeds over 512 Kbps. Policy will aim at increasing broadband penetration and convergence of various platforms like cable TV, optical fiber, wireless connection through spectrum, VSAT and satellite and bring them under one department of DOT. The Policy may also look at providing affordable broadband equipments and devices for end consumer use. Read More

  • Technology, Media & Telecom
    E-manufacturing clusters mooted

    The Communications and Information Technology (IT) Ministry proposes to develop new manufacturing clusters for electronic goods in eight cities of Bhopal, Bhubaneswar, Hyderabad, Maheshwaram, Bhiwadi, Jabalpur, Hosur and Kakinada to boost manufacturing and increase employment opportunities. Government would offer subsidies and incentives to companies setting up facilities in these eight cities.

    The government proposes to further extend the modified special incentive subsidy scheme (M-SIPS) to Ahmedabad, Ghaziabad, Vadodara, Gandhinagar, Nagpur, Nashik, Aurangabad and Thane. In July 2012, M-SIPS were notified for the first time under which refunds on capital expenditure for new units or for expansion of more than 25% of existing capacity in specific new or existing electronic clusters will be given. Read More

  • Food & Pharma
    Health Ministry mulls new plans

    The Health Ministry initiated consultation on government action plan for the first 100 days with respect to healthcare reforms. The new health policy has been mulled along with the rural health program, mission mode project for malnutrition, plan for a program for senior citizens and reviewing the existing geriatric care program. Disease Management Association of India anticipates that the plan will also cover the long forgotten issues of telemedicine, mHealth and setting up of National eHealth Authority.

    PSA view – Its good that government is showing concerns and proactively initiating the planning stage. The need of the hour is streamlining the whole process in a systematic manner so that healthcare becomes easily accessible to the common man. Read More

  • Technology, Media & Telecom
    Re-discussing the royalty payment issue

    The DIPP is likely to bring a discussion paper for review of the proposal on 50% rise in royalty payments by Indian companies to their foreign partners or parents. So, essentially, the paper will invite comments on whether or not the royalty ceiling applicable till 2009 should be re-imposed. Know that until December 16, 2009, lump sum royalty payments were capped at $2 million. For the cases where there were no flat rates, royalty payment for technological collaboration was capped at 5% of the domestic sales and 8% of exports. Further, for the usage of a brand name, royalty could be paid up to 1% of sales and 2% of exports. Beyond these levels, approval of the Foreign Investment Promotion Board was required. Read More

  • Food & Pharma
    Ministry amended the Rules

    The Ministry has amended the Rules and now, in Schedule Y of the Drugs and Cosmetics Rules, 1945, in paragraph 2(2)(iv) relating to responsibilities of Sponsor, the clause will read “(iv) Any report of the serious adverse event, after due analysis shall be forwarded by the sponsor to the Licensing Authority as referred to in clause (b) of rule 21, Chairman of the Ethics Committee and the Head of the Institution where the trial has been conducted within fourteen calendar days of the occurrence of the serious adverse event.” In case the investigator fails to report any SAE within the stipulated period, he will have to furnish sufficient reason for the delay to the satisfaction of the licensing authority. The SAE report should be sent to the licensing authority, chairman of the EC and the head of the institution where the trial has been conducted within 14 days of the occurrence of the SAE. For EC, the amendment says that “In case of serious adverse event occurring to the clinical trial subjects, the Ethics Committee shall forward its report on the serious adverse event, after due analysis, along with its opinion on the financial compensation, if any, to be paid by the Sponsor or his representative, whosoever had obtained permission from the Licensing Authority as referred to in clause (b) of rule 21 for conducting the clinical trial, to the Licensing Authority within thirty calendar days of the occurrence of the serious adverse event.” Read More

  • Technology, Media & Telecom
    India gets ready to set up cyber snooping agency

    India will soon be setting up a federal internet scanning agency called NCCC to spy all internet accounts and online data. NCCC is to monitor cyber security threats and inform concerned law enforcement agencies for proactive action to prevent crime. NCCC will collect and integrate internet traffic data from different gateway routers of major ISPs at a centralized location for analysis. NCCC would be set up at a cost of INR 10 billion and all top government spy and technical agencies including Department of Telecommunication, Intelligence Bureau, Research and Analysis Wing, Indian Computer Emergency Response Team, Army, Navy, Air force, National Security Council Secretariat, Defence Research and Development Organization will play an active role in the functioning of NCCC. Read More

  • Food & Pharma
    Revised FDI policy in pharma

    Cabinet Committee on Economic Affairs had decided in November 2013 and conveyed its decision to the Department of Industrial Policy and Promotion (“DIPP”) regarding the changes in the FDI policy in pharmaceutical sector. The announcements to continue with the same FDI limits were taken earlier this year. The current position is that 100% FDI is allowed in both Greenfield (new) Brownfield (existing) segments and the investments under the Brownfield is subject to approval by the Foreign Investment Promotion Board (“FIPB”). However, DIPP has said that a “non-compete clause” will not be allowed except in special cases and that too with the prior approval of FIPB. Read More

  • Technology, Media & Telecom
    Telecom M&A guidelines to be in place

    The Telecom Secretary MF Farooqui has announced that M&A guidelines for the telecom sector should be out within the next ten days. The Empowered Group of Ministers (EGoM), which has approved the guidelines, has sought legal opinion on whether consolidation of companies would amount to sale of equity, violating the lock-in period rule of the telecom license. As per the guidelines approved by the EGoM, the market share of a merged entity should not exceed 50%. Telecom companies that bought spectrum in auctions won’t have to make additional payments to the government for radiowaves after a merger. Only companies that acquire telecom operators that had been allocated spectrum will have to pay the difference between the market rate and the old rate to the government. Read More

  • Food & Pharma
    DoP’s constant efforts to fix patent drugs’ prices

    Even after facing utter failure in fixing the prices of patented drugs in the country DoP is back in action, this time with an inter-ministerial committee of joint secretaries of different ministries to look into the issues and suggest ways and means to fix the prices of patented drugs. The inter-ministerial committee has been constituted in light of the diverse opinion of different stakeholders received on DoP’s earlier report on patented drugs. In its past report on the issue, DoP committee had recommended a formula on price negotiation of patented drugs, linking it to the per capita income in the country and had also suggested that the price of patented drugs should be frozen before the drugs are marketed. Read More

  • Technology, Media & Telecom
    Delhi High Court granted respite to broadcasters

    Yesterday, the Delhi High Court not only asked the TRAI to not take action against broadcasters who exceeded the ad-cap enforced by TRAI but also asked the broadcasters to maintain records of the airtime on a weekly basis. The TRAI regulations significantly restrict advertising on television, which, if imposed, will accelerate the growth of digital advertising in India, with video advertising, in particular, benefiting from this move. The maximum duration limit of advertisements allowed was 12 minutes per hour, but with the leftover advertisement duration (if any) carried over to the next hour. This is applicable to advertising spots, info-commercials and house inventory from the broadcaster. Ad breaks were allowed only during breaks for live sporting events, like half time in football or hockey match. Only full screen ads were allowed. Broadcasters were asked to ensure that the audio level of advertisements should not be higher than the audio level of the programs and finally, the broadcasters had to submit the details of ad carried in their channel in the format specified by TRAI, within 15 days from the end of a quarter. The broadcasters had filed a case in the Delhi High Court following the dismissal of their appeal before the Telecom Dispute Settlement Appellate Tribunal on jurisdictional grounds. This was because the Supreme Court had struck down TDSAT’s powers to adjudicate against TRAI regulations. The next date of the next hearing is March 13, 2014. Read More

  • Food & Pharma
    100% FDI has brought new trend to unnerve the domestic pharma sector

    The 100% FDI in pharma sector through automatic approval route in new projects and investments in the existing companies only through the approval route has prompted several acquisitions and not given the desired result. The major acquisitions in pharma sector have been the Daiichi Sankyo taking control of Ranbaxy Labs, Sanofi-Aventis acquiring Shantha Biotechnics and Mylan Inc acquiring Agila Specialties. As over 96% of the total FDI has been into brownfield pharma projects, MNCs have so far taken control of 35% of the domestic pharma business. Seeing this trend, recently, the Parliamentary Standing Committee of Commerce had mounted pressure on the government, calling for a blanket ban on FDI in existing pharma projects and putting an end to the take-over of domestic companies by foreign players. The Health Ministry had even suggested more stringent norms like limiting the FDI cap at 26%, which was turned down by the DIPP. Read More

  • Technology, Media & Telecom
    National Cyber Security Policy 2013 (“Policy”)

    The objectives of the Policy include: (a) setting up of an effective mechanism to obtain strategic information relating to cyber threats; (b) protection of Critical Information Infrastructure; (c) creation of a skilled workforce in cyber security; (d) protection of data during transit; (e) effective prevention, investigation and prosecution of cyber crimes; and  (f) creation of a global understanding and cooperation on cyber security.

    As per the Policy, the foremost strategy is to create a secure cyber ecosystem by providing for a nodal agency to coordinate cyber security matters, encourage companies to designate a senior member as “Chief Information Security Officer” and promote organizations to develop information security policies. Other strategies involve conformity with global best practices and certification to the various standards, strengthening of the regulatory framework and periodic review against emerging threats. The Policy talks about the operation of a national level body called the Computer Emergency Response Team (CERT-In) to coordinate all efforts relating to cyber security and work as an umbrella organization. Read More

  • Food & Pharma
    Apollo Group ties up with government to expand its telemedicine services base

    Apollo Hospitals Group has tied up with  Common Services Centres (“CSC”), a scheme of the Union Government under the Department of Electronics and Information Technology in Delhi, to deliver healthcare to rural patients using telemedicine facilities. Apollo Hospitals has been in the realm of telemedicine services since last 13 years. Both Apollo and  CSC have signed an MoU and aim to render primary and preventive healthcare to rural patients through tele consultation. This will enable rural patients to share their medical reports or radiology images with doctors and hence afford an all round investigation and an accurate diagnosis of their medical ailments. Read More

  • Food & Pharma
    Regulating Clinical Trials

    The Supreme Court has asked the government to discuss with states all facets of a legal framework to regulate and monitor clinical trials of new drugs by foreign firms across India. The court also asked the petitioner Swasthya Adhikar Manch, the National Human Rights Commission, NGOs and other organizations to submit their suggestions before the next hearing on Sept 24, for strengthening the legal regime to regulate clinical trials so as to minimize the harm to the patients upon whom the new drugs were being tested. Meanwhile, the Drug Controller General of India (“DCGI”) has reacted very strongly to the various complaints regarding the independent ECs attached to hospitals and CROs, which continue to review and approve new clinical trials in violation of norms as these ECs are permitted only to conduct periodic review of the ongoing clinical trials already approved by them only. They have been warned of stern action. DCGI is also awaiting the enactment of the amendments to the Drugs and Cosmetics Act, which would bring all medical devices under the regulatory mechanism helping to raise the standard of this niche products. Read More

  • Food & Pharma
    Regulating clinical trials

    The Supreme Court has asked the government to discuss with states all facets of a legal framework to regulate and monitor clinical trials of new drugs by foreign firms across India. The court also asked the petitioner Swasthya Adhikar Manch, the National Human Rights Commission, NGOs and other organizations to submit their suggestions before the next hearing on Sept 24, for strengthening the legal regime to regulate clinical trials so as to minimize the harm to the patients upon whom the new drugs were being tested. Meanwhile, the Drug Controller General of India (“DCGI”) has reacted very strongly to the various complaints regarding the independent ECs attached to hospitals and CROs, which continue to review and approve new clinical trials in violation of norms as these ECs are permitted only to conduct periodic review of the ongoing clinical trials already approved by them only. They have been warned of stern action. DCGI is also awaiting the enactment of the amendments to the Drugs and Cosmetics Act, which would bring all medical devices under the regulatory mechanism helping to raise the standard of this niche products. Read More

  • Technology, Media & Telecom
    100% FDI allowed in telecom sector

    In a meeting of the Department of Policy and Promotion chaired by Prime Minister on July 16, 2013, it was announced that FDI limit in the telecom sector has been increased to 100%. The earlier limit was 74%. As per latest announcements, investment up to 49% is allowed to come in through the automatic route and investment above 49% is required to be brought in through the government route i.e. approval of the Foreign Investment Promotion Board. Read More

  • Food & Pharma
    AIOCD to move SC against DPCO 2013

    AIOCD has decided to move the SC against the DPCO 2013. AIOCD believes that the DPCO 2013 is not cost based and would benefit pharma manufacturers who produce low cost drugs. Further, the AIOCD will make a plea to the SC requesting it to address the long pending demand of revising margins on the 74 drugs which are still at 16% and 8% for retailers and wholesalers, respectively. DPCO 2013 has further reduced this margin by 4% and 2%, respectively for retailers and wholesalers on 348 drugs. The existing basis of calculating the prices is the simple average formula, which has already been challenged by a civil society group, All India Drug Action Network (AIDAN). DPCO 2013 provides that the ceiling price will be based on the simple average of the prices of all brands of a drug that have a market share of at least 1%. Read More

  • Technology, Media & Telecom
    SEBI and RBI will also get access to CDR

    Now, SEBI and RBI will also get access to CDR so that they can keep a vigil on the economic offences including insider trading. According to section 92 of the Criminal Procedure Code, only police has the authority to access CDR based on a FIR. Therefore, government is considering bringing some amendments in the Indian Telegraph Act.  It has been mooted that in order to access CDRs from the telecom service provider some other means like mandatory authorization by home secretary or joint secretary in the home ministry should also be introduced. Read More

  • Food & Pharma
    Department of Health Research signs MoU with NIHCE

    The MoU between Department of Health Research and NIHCE provides the framework for strategic and technical cooperation between the two countries with an aim to (i) bring modern health technology to people by encouraging innovations; (ii) translate these innovations into products/processes by facilitating evaluation; (iii) introduce the aforesaid innovations into public health service. The two countries will also exchange institutional expertise and experience on clinical trial guidelines, quality standards, application of health technology assessment and implementation of the decisions of the assessment into clinical policy and practice. They will also explore the opportunities for collaborative research projects in clinical policy and practice. Read More

  • Technology, Media & Telecom
    Delhi High Court issued notice to Department of Telecommunication (“DoT”) on Vodafone’s plea for extension of 2G license

    Vodafone, India’s second largest telecom operator, has approached the Delhi High Court challenging the decision of the DoT which denied extension of their 2G spectrum licenses in Delhi, Mumbai and Kolkata circles. The DoT has refused to extend the said licenses stating that it has been granted only for a period of 20 years and, therefore, on the completion of the said time period the interested telecom operators will have to participate in the auction process for issue of fresh licenses. But, Vodafone had sought an extension of its licenses in aforesaid three circles in the 900 MHz band in December, 2012, citing clause 4.1 of the license agreement under which the government can extend the period of license by 10 years at a time if the request is made by the operator during the 19th year of the license period. After hearing Vodafone’s plea, Justice Rajiv Shakdhar has posted the matter for hearing on August 29, 2013 and issued notice to the DoT to file their response before the aforesaid hearing date. Read More

  • Technology, Media & Telecom
    Supreme Court banned Bharati Airtel from enrolling new customers for 3G services in seven circles

    SC in its order dated April 11, 2013 has directed Bharati Airtel, India’s largest mobile service provider, not to extend its third generation (3G) high speed data services for new customers in seven circles where it failed to obtain requisite licenses from Department of Telecommunication (“DoT”). The seven circles are Kolkata, Madhya Pradesh, Haryana, Gujarat, Maharashtra, Uttar Pradesh East and Kerala. However, the said decision does not affect the existing customers and the Bharati Airtel shall continue to provide 3G services through its mutually beneficial agreements entered with other mobile service providers, namely, Vodafone & Idea. The said agreements are the subject matter of the issue. According to DoT, Bharati Airtel is in  violation of rules and has issued notices to Bharati Airtel to stop providing 3G services in the aforesaid seven circles and also imposed a penalty of INR 3500 million. Read More

  • Aviation
    Aircraft Acquisition Committee abolished

    The Civil Aviation Ministry (“Ministry”) has simplified norms for import of  aircrafts into India by abolishing the Aircraft Acquisition Committee (“AAC”). An initial No Objection Certificate (“NOC”) to launch scheduled or non-scheduled air transport services and in-principle approval for acquisition of aircraft is still required from the Ministry, as this is a statutory requirement under the Aircraft Rules and Reserve Bank of India guidelines.  But, the permission for actual induction of aircraft is no longer required from the Ministry. Read More

  • Food & Pharma
    45 upcoming pricing regime days to comply to

    The government may give drug companies just 45 days to comply with the upcoming pricing regime that promises cheaper essential medicines, making it mandatory for companies to conform to revised rates irrespective of the date of manufacture. The intent is to cater to the consumer’s interest by not allowing the manufacturers to sell the previous batches at non-revised price. The industry officials, on the other hand, have criticised this step claiming that the directive could lead to chaos and even shortage of essential drugs in the short term. As per them, the task of recalling batches “from every nook and corner” is a logistic nightmare which could lead to losses on account of price-cut, labelling and additional freight movement. Factoring this, the government intends to allow pharma companies to send a supplementary price list of revised prices that the retailers will have to display in their premises. Read More

  • Food & Pharma
    Government to regulate rates of 652 medicines; prices set to fall

    The government, on May 16, 2013, notified new norms that will bring down prices of essential medicines, increase the number of drugs under price control, and alter the way the government regulates prices in the 72,000 crore domestic market. The new regime will replace an 18 year old price control order and come into effect 45 days from now. The government will regulate the rates of 652 medicines, a substantial increase over the 74 bulk drugs and their formulations that are currently under price control. The current method of fixing prices on a cost-plus basis will be replaced by market price-linked cap for each drug. Read More

  • Technology, Media & Telecom
    Justice Verma Committee recommends changes in crime against women and right to privacy

    On December 23, 2012, a three member Committee with Justice Leila Seth, former judge of the High Court, Gopal Subramanium, former Solicitor General of India and headed by Justice J.S. Verma, former Chief Justice of the Supreme Court was constituted to recommend amendments to the criminal law to improve the justice delivery system in cases of sexual assault against women. The Committee submitted its report on January 23, 2013. The major recommendations suggested by the committee were on the laws related to rape, acid attack (Criminal Laws Amendment Bill, 2012), sexual harassment (Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Bill, 2012), trafficking (Immoral Trafficking Prevention Act, 1956), child sexual abuse (Juvenile Justice Act, 2000), medical examination of victims, police, electoral (Representation of People Act, 1951) and educational reforms. New definitions of stalking and voyeurism have been recommended and, in turn, have introduced the elements of privacy. The definition of voyeurism borrows elements from section 66E of the Information Technology Act and improves it further. Certain suggestions are in line with the Criminal Laws Amendment Bill, 2012 which is currently pending in Parliament. Read More

  • Aviation
    Government plans to push Aviation Infrastructure Development

    The Indian Government is planning to build 10-15 new Greenfield Airports and modernize 50 others in metro cities as discussed in the 49th Conference of Directors General of Civil Aviation of Asia-Pacific region in New Delhi on October 08, 2012. The civil aviation minister said that Government now permits up to 100% FDI in Greenfield airports. The basis of this move is that middle class is growing, trade is expanding and India should achieve at least six per cent GDP growth now. There may have been a temporary setback, but air traffic is expected to grow substantially. Read More

  • Technology, Media & Telecom
    National Telecom Policy 2012 (“Policy”)

    The Policy received the assent of the union cabinet on May 31, 2012 and promises to change the face of telecommunications and broadcasting in India. The Policy will mostly likely be implemented on April 1, 2013 and will replace the New Telecom Policy 1999. The Policy aims at providing a pan India license, free roaming facility, affordable broadband and adequate availability of spectrum. The Policy plans on adopting what is known as the green policy in telecom. It will simplify the licensing framework, set up a common platform for interconnection and evolve a policy framework for financing the telecom sector. The Policy’s main focus will be on convergence of services i.e. voice, data, video, Internet telephony, value added services and broadcasting services, convergence of networks i.e. access network, carriage network (NLD/ILD) and broadcast network and convergence of devices i.e. telephone, personal computer, television, radio, set top boxes and other connected devices as well as convergence of local cable TV networks post digitalization. It will facilitate resale at the service level both wholesale and retail and enable and enforce Voice over Internet Protocol (“VOIP”) facility. The Policy will also review the Telecom Regulatory Authority of India Act (“TRAI”) and the Indian Telegraph Act. Read More

  • Food & Pharma
    DCGI issues notices to streamline granting of licenses

    The first notice was a direction under section 33(P) of the Drugs and Cosmetics Act, 1940 (“Act”) for grant/renewal of manufacturing license of drug formulations in proper generic names only. The DCGI has pointed out that the current practice of granting license by endorsing trade name as submitted by the applicant is not in compliance with the Act. What the Act prescribes is mentioning the name of the drug and not the brand or trade name. So, it has been instructed to the state licensing authorities that the licenses should be granted to generic/proper names only and in case of drug formulations containing multiple ingredients, license should be granted under the name of the categories of products. The composition of such product should also mention the name of active ingredients and the strength. The second notice from DCGI was concerning the cancellation of license to manufacture drug formulations falling under the purview of “new drugs.” As defined under Rule 122E of the Rules, it is mandatory to procure prior approval of DCGI before granting license under this category but the state licensing authorities were granting licenses without prior approval of the DCGI. Therefore, the DCGI has instructed the state authorities to follow the law and the procedure prescribed under the Rules. Read More

  • Food & Pharma
    Government plans new legislation to take DPCO out of ECA ambit

    The government plans to bring a new legislation for price control and monitoring of drugs. The Drugs Price Control Order (“DPCO”) which is presently mandated under the ECA would be swapped by specific legislation covering the issue of price control and monitoring of drugs. The new policy, aims to bring 348 essential drugs under price control. The National Pharmaceuticals Pricing Authority will be the implementation authority for the new policy and the new DPCO. According to the existing DPCO, the pricing regulator fixes prices of 74 bulk drugs, and all medicines containing one or more of these bulk drugs. However, the existing drug pricing policy will only be replaced over a period of time. Read More

  • Aviation
    Indian carriers may face downgrade threat

    The FAA, the authority regulating aviation in the US has issued safety alters for operators functioning in the US. While this does not directly impact operations in India, it does in fact reduce the ratings for Indian training and safety standards and so operators functioning out of India have a reason to worry as they could get barred from flying to the US. The FAA’s Safety Alert for Operators was issued for airlines and aviation regulators of many countries including India and provides specifically for degradation in pilot’s skills. The FAA in this alert has also made an observation that mostly all incidents and malfunctions occur due to manual handling which is not up to the mark due to the systems being highly automated and the fact that over-reliance on automated systems eventually leads to deterioration in a pilot’s ability to recover the aircraft from an undesired position or situation. Read More

  • Technology, Media & Telecom
    Tamil Nadu to bring cyber offenders under Goondas Act

    The Tamil Nadu government has announced that it will make amendments to its existing Goondas Act to include cyber crimes. Currently, the Goondas Act includes prevention of dangerous activities of bootleggers, drug offenders, forest offenders, goondas, immoral traffic offenders, sand offenders, slum grabbers and video pirates. The Goondas Act can be invoked for habitual offenders. The nature of cyber crimes that will warrant detention under the Act has not been defined yet, but any offence or offences targeting a larger segment of innocent people with intent to commit fraud or endanger their safety would be considered serious enough for detention under the Goondas Act. Read More

  • Technology, Media & Telecom
    Report of the Group of Experts on Privacy

    The Report identifies key privacy issues while keeping in view the international landscape of privacy laws, global data flows and predominant privacy concerns with rapid technological advancements and proposes a detailed framework that serves as the conceptual foundation for the Privacy Act for India. The five salient features of such a framework: (i) Technological Neutrality and Interoperability with International Standards; (ii) Multi-Dimensional Privacy, including privacy-related concerns around data protection on the internet and challenges emerging there from, appropriate protection from unauthorized interception, audio and video surveillance, use of personal identifiers, bodily privacy including DNA as well as physical privacy, which are crucial in establishing a national ethos for privacy protection; (iii) Horizontal Applicability both to the government as well as to the private sector; (iv) Conformity with Privacy Principles drawn from best practices internationally, and adapted suitably to an Indian context, with the intention to provide the baseline level of privacy protection to all individual data subjects. The fundamental philosophy underlining the principles is the need to hold the data controller accountable for the collection, processing and use to which the data is put thereby ensuring that the privacy of the data subject is guaranteed; and (v) Co-Regulatory Enforcement Regime, like establishment of the office of the Privacy Commissioner, both at the central and regional levels as the primary authority for enforcement of the provisions of the proposed Privacy Act. Read More

  • Food & Pharma
    DCGI issues notices to streamline granting of licenses

    The first notice was a direction under section 33(P) of the Drugs and Cosmetics Act, 1940 (“Act”) for grant/renewal of manufacturing license of drug formulations in proper generic names only. The DCGI has pointed out that the current practice of granting license by endorsing trade name as submitted by the applicant is not in compliance with the Act. What the Act prescribes is mentioning the name of the drug and not the brand or trade name. So, it has been instructed to the state licensing authorities that the licenses should be granted to generic/proper names only and in case of drug formulations containing multiple ingredients, license should be granted under the name of the categories of products. The composition of such product should also mention the name of active ingredients and the strength. The second notice from DCGI was concerning the cancellation of license to manufacture drug formulations falling under the purview of “new drugs.” As defined under Rule 122E of the Rules, it is mandatory to procure prior approval of DCGI before granting license under this category but the state licensing authorities were granting licenses without prior approval of the DCGI. Therefore, the DCGI has instructed the state authorities to follow the law and the procedure prescribed under the Rules. Read More

  • Technology, Media & Telecom
    Local Industry associations raising demands for preference

    The Metal Recycling Association of India, which represents India’s ferrous and non-ferrous metals recycling industry with the aim to promote all types of metal recycling within India urged the government to do away with an import duty levied on metals recycling equipment and on radiation detection equipment. There is a complete absence of formal organized metals recycling industry structure, any domestic laws or any designated zone for metals recycling. As the recycled metal scrap converts waste into resource, it has tremendous environmental and economical benefits, apart from the employment this industry generates. In a similar demand, the Indian Electrical and Electronics Manufacturers Association recently requested the government to provide greater encouragement to indigenous manufacturing as compared to imports. There has been great achievement in the power generation and transmission & sub-stations capacity addition targets but the domestic manufacturers of power equipment have not gained correspondingly. This request has come in the wake of the great surge in imports of cheap and inferior quality electrical equipment from abroad, which is significantly impacting the domestic electrical equipment industry. Interestingly, to boost indigenous manufacturing of telecom products and keeping in view the security concerns of the country, the government has approved the preferential market access policy to support the domestic manufacturers and give preference to the domestically manufactured telecom and electronic products and also issued notices to various departments to start implementing this with immediate effect. This policy will be in force for 10 years. Read More

  • Food & Pharma
    Good Distribution Practices for biological products

    The CDSCO has issued the Draft for biological products with the objective to assist in ensuring the quality and identity of biological products during all aspects of the distribution process. These aspects include, but are not limited to procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices. The Draft shall be applicable to all persons and outlets involved in any aspect of the storage and distribution of biological products, including the manufacturers, wholesalers, suppliers, distributors, government institutions, international procurement organization, donor agencies and certifying bodies, logistics providers, traders, transport companies and forwarding agents and their employees as well as health workers. All parties involved in the distribution of biological products shall have the responsibility to ensure that the quality of biological products and the integrity of the distribution chain are maintained throughout the distribution process from the site of the manufacturer to the entity responsible for dispensing or providing the product to the patient or his or her agent. Even the government, custom agencies, law enforcement agencies, regulatory authorities shall ensure the quality and safety of biological products and prevent the exposure of patients to spurious biological products. An agreement must be executed with all agencies involved in the storage, transportation and distribution. Read More

  • Technology, Media & Telecom
    Government launches “data.gov.in”

    The Indian government has recently launched “data.gov.in”, a joint initiative of Government of India and US Government, and will be on the lines of the US government’s open data initiative, “data.gov.” For this website, the US General Services Administration developed the data management system module and National Informatics Centre of India designed and developed the website together with its content management system and the visitor relation management module. The website offers department wise and category wise metrics and visitor statistics for data sets and apps. The website has been tested for compliance with the guidelines for Indian government websites and has been found suitable for usage for even person with disabilities. The site also offers apps from government departments for end-users/citizens. Like, Pocket Bhuvan, a geospatial app from the Indian Space Research Organization, with specific emphasis on Indian region and showcases Indian imaging capabilities. Initially, the data related to agriculture, health and energy will be made public and subsequently on transportation, water, sanitation and railways. Read More

  • Aviation
    DGCA’s Flight Duty Time Limitations guidelines implemented by Air India

    DGCA asked Air India to implement the new FDTL guidelines effective September 16, 2012. FDTL basically deals with six parameters including maximum daily flight duty period and flight time, weekly/monthly/annual limitation of flying hours, rest period, staff on duty travel or position and number of landings. One of the key elements of the FDTL guidelines is that pilots have to be available for 9-10 hours daily as opposed to the current 6.5-7 hours availability. Air India will now have to adhere to the Civil Aviation Requirement (“CAR”) containing the new FDTL guidelines instead of going by the present agreements inked with different pilot unions. This has caused discontentment amongst the Air India pilots forming part of the Indian Commercial Pilots Association (“ICPA”). ICPA is of the opinion that implementation of FDTL guidelines without discussion with the pilots is arbitrary and illegal. Read More

  • Technology, Media & Telecom
    Testing laboratories for IT products

    The Indian government is all set to establish 15 new laboratories for testing IT (both hardware and software) products under the PPP model having national and international accreditation and recognitions in the area of testing and calibration. With 15 new laboratories, the total number of such laboratories will rise to 20 as there are already five such laboratories in Delhi, Mumbai, Kolkata, Bangalore and Noida. These laboratories fall within the aegis of the Department of Electronics and Information Technology. It will allow the IT companies to test their products in the laboratories before marketing them in India. The products will have to be registered in accordance with the safety standards for such products prescribed by the government. These laboratories would be part of Standardization Testing and Quality Certification and their services would include testing, calibration, IT and e-Governance, training and certification to public and private organizations. Read More

  • Aviation
    Air carriers required to submit foreign operation plans to the Ministry

    The Civil Aviation Ministry (“Ministry”) has sought the foreign operation plans till 2014 from all domestic airlines. This move is in light of major expansion in operations carried out by foreign airlines and the Ministry wants to assess the level of preparedness of domestic airlines to meet the challenge. The Ministry plans on holding a meeting for discussing the foreign operation plans wherein the data in terms of flight crew, fleet size, and bilateral rights used would be discussed and the areas for improvement will be identified. Read More

  • Food & Pharma
    Mandatory to register Ethics Committee

    The CDSCO has issued the Draft thereby making the registration of ethics committees mandatory in India, which shall come into effect after publication in the official gazette. Under the existing regulations, registration is mandatory only for the clinical trials and not for the ethics committees. However, now it shall be mandatory for the ethics committee to be registered as well. The registration shall be valid for a period of 5 years from the date of issue, unless not cancelled or suspended before. Read More

  • Food & Pharma
    Unique ID for Drugs

    In order to check the supply of fake prescription drugs, the task force headed by the Gujarat Food and Drug Control Administration has suggested that drug companies should start printing a unique ID number to help users’ cross-check through an SMS the identity of the drug. This unique ID shall be an authorized number which will assist to authenticate the drugs in the market. This suggestion is now awaiting the approval from the Union Health Ministry, which is expected to come soon with a two-phase implementation strategy, beginning with top selling drugs and then covering the entire market. The existing norms mandates that the drugs have the brand name, generic name, batch number, date of manufacturing & expiry, address & customer complaint details of the manufacturer. The new feature of ID code will enable to verify these details by sending an SMS with the ID code. This will add to the credibility and authenticity to the drugs. Read More

  • Technology, Media & Telecom
    Cap on personal SMSs quashed

    On July 13, 2012, the DHC set aside an order of TRAI that had capped the sending of SMSs at 200 per day per person for personal communications. The DHC has; however, allowed this restriction for unsolicited commercial communication SMSs. This restriction was brought about by the Telecom Commercial Communications Customer Preference Regulations, 2010 which was supposed to be an adequate step to curb the menace of unsolicited commercial SMSs; however, little did people realize that this blanket ban will also affect the personal SMSs. TRAI had asked telecom operators to limit the number of SMSs per day per SIM to 100, which was later increased to 200. While discussing the objective of unsolicited SMSs, the DHC observed that they are normally commercial advertisement meant for furtherance of trade and commerce and not sent with the objective of propagation of ideals, social, political or economic or in furtherance of literature or human thought. Accordingly, it felt that this restriction when made to apply on personal SMSs, infringes the freedom of speech of the citizens and, therefore, should be done away with. Read More

  • Technology, Media & Telecom
    Telecom Policy 2011 approved by the Cabinet

    On May 31, 2012, the Union Cabinet cleared the National Telecom Policy 2012 which proposes a host initiatives in the telecom regime in India and crucially includes free roaming, unrestricted net telephony and a new unified licensing regime for operators. The new policy targets to increase transparency and breathe life into the telecom sector. The telecom sector was deeply affected by the huge scandal over licensing. The policy gives specific emphasis to push broadband uptake and increase local manufacturing of telecom equipment. The policy envisages to introduce inter-circle mobile number portability, which will enable users carry their phone number from one state to another. Currently, this is allowed only if the user wants to change operator in the same circle. Further, the unrestricted internet telephony will allow subscribers to use the internet to make local and STD calls to a fixed or mobile user. The policy also seeks to ease merger and acquisition rules in the sector to facilitate consolidation in the crowded market. The policy will also separate operator licenses from spectrum awards and institute market-derived pricing for radio frequencies. Read More

  • Food & Pharma
    Procedures and quantum of compensation to victims of trials

    The Health Ministry is all set to formally notify the procedures and amount of compensation to be paid by the sponsors, if a volunteer dies or gets injured during a clinical trial. The draft rules for the new schedule Y1 under the Drugs and Cosmetic Rules, 1945 were already published and with a view to tighten the norms on clinical trials, several sections of the amendment have already been implemented. However, the detailed procedures and amount of compensation to be payable is yet to be completed and is expected to be notified in a couple of months. The Drug Technical Advisory Board has provided its go ahead to CDSCO to prepare a “compensation chart” or extensive guidelines that will specify the amount to be paid. Ethical committees of the company will have to decide the quantum of compensation on the basis of these guidelines. The Indian Council of Medical Research recently framed draft guidelines for compensation to participants for research-related injury. With the notification, these guidelines will be made effective as rules. Read More

  • Food & Pharma
    Planning Commission recommends Central Drug Authority for strengthening drug regulation

    The SC of the Planning Commission established to finalize the 12th Health Plan for the Ministry of Health and Family Welfare has recommended the constitution of a CDA to weed out irrational fixed dose combinations and for implementing an effective e-governance system. The recommendation follows the Mashelkar Committees report for establishment of a CDA to be the central agency for issuing licenses to manufacturers and sale of drugs. The SC has also recommended that the drug regulator needs to accord priority to pharmacovigilance, adverse drug response monitoring, quality control, testing, revaluation of registered products and post marketing surveillance. The SC has further recommended that medical devices be included under the Drugs and Cosmetics Act for according risk based classification and regulation of clinical trials, conformity assessments and penalties specifically for medical devices. Read More

  • Technology, Media & Telecom
    Mobile Banking (Quality of Service) Regulations, 2012

    The TRAI has taken a strong measure to encourage the uptake of mobile banking in India by releasing the “Mobile Banking (Quality of Service) Regulations 2012”. This is aimed at defining the Quality of Service (QoS) standards for mobile banking, in order to facilitate faster and reliable communication means to enable the service. For this, the service providers are required to facilitate the banks to use SMS, USSD and IVR to provide banking services to its customers and optionally facilitate the banks to use WAP or STK. The response time to deliver the message for mobile banking services generated by the customer or the bank ought to be within the timeframe of less than or equal to 10 seconds for SMS, WAP, IVR and STK and less than or equal to two seconds for USSD. If the SMS sent by the bank is not delivered within the aforementioned timeframe, an USSD communication should be sent to the customer confirming completion of the transaction. For mobile-based financial transactions, the operators are required to meet the QoS standards defined by TRAI. Operators are required to maintain complete and accurate records of such transactions. The TRAI has prescribed that the confidentiality of end to end encryption, integrity, authentication and non-repudiation of communication shall be in accordance with the standards certified by ITU/ETSI/TEC/International standardization bodies such as 3GPP/3GPP2/IETF/ANSI/TIA/IS or any other international standard as may be approved by the central government. Read More

  • Technology, Media & Telecom
    Telcos ads to be shorter says TRAI

    The Telecom Regulatory Authority of India (“TRAI”) has recently recommended the restriction on the number of minutes telecom companies will be allowed to advertise on television. According to media reports, the regulator intends to limit minutes of advertisement to 12 minutes an hour. In this light, media companies feel that broadcasters would find it difficult to justify high rates for advertisements vis-à-vis the lower volumes that will be enforced due to the TRAI’s announcements. Read More

  • Aviation
    Government reminder to phase out ex-pat pilots

    The Government has again in May reminded airlines of the 2013 deadline to phase out ex-pat pilots. The Government reminder comes in light of the recent weakening of the rupee and the continued reliance on import of ATF which is proving to be a great burden on profitability. This is also an effort to raise the standards of Indian pilots and since more and more Indian pilots are now available, the government wishes utilization of local talent rather than hiring expensive foreign pilots. Read More

  • Food & Pharma
    FIPB to clear brownfield investments in pharma companies

    In October, an inter-ministerial group headed by the prime minister decided to make the Competition Commission of India (“CCI”) the approving body for foreign investments in the pharma sector. At the meeting it was also decided that the Foreign Investment Promotion Board (“FIPB”) would approve investment proposals for an interim six-month period, which ended in April, 2012. However, the guidelines authorizing CCI to act as the approving body have still not been finalized. Meanwhile, the FIPB has stopped clearing foreign investment proposals on the grounds that specific conditions for considering cases of brownfield foreign investment in the pharma sector were under formulation. The matter got further complicated by the fact that the FIPB’s six-month window for considering foreign investment proposals in this sector expired. To end this confusion, the department of pharmaceuticals has mooted a proposal to allow the country’s foreign investment approving body to continue clearing stake purchases by foreign firms in Indian drug companies. Read More

  • Aviation
    Government to provide concessions to airline industry

    The Government has announced its plans to allow airlines to directly import ATF and 49% FDI in the aviation sector as a measure to try and revive the ailing sector. In addition to these measures, the government is contemplating allowing private carriers to operate more international route by sharing its bilateral traffic rights which was previously reserved for the national carrier. Further, the government has announced 100% FDI under the automatic route for greenfield airports to facilitate more international traffic across India as well as formulating an Air Cargo Promotion Policy in an effort to encourage cargo operations from India. Read More

  • Competition
    Exempted acquisition- increase in shareholding limit

    1.        Exempted acquisition- increase in shareholding limit

    Threshold limit for acquisition of non-controlling stake in enterprise(s) solely for the purpose of investment or in the ordinary course of business has been enhanced from 15% to 25%.

    2.       Intra-group mergers/amalgamations

    Exemption has been introduced for intra-group mergers or amalgamation between: (i) wholly owned subsidiaries of the parent company inter-se, or (ii) wholly owned subsidiary with the parent company. This is in addition to the exemption for intra-group acquisitions already provided under the Combination Regulations. Read More

  • Aviation
    Union Budget propose equity infusion of 4,000 crore into Air India

    Union Budget 2012-13 presented by Finance Minister Mr. Pranab Mukherjee has proposed equity infusion of INR 4,000 crore into Air India. The equity infusion of INR 4,000 crore will help in improving the debt-equity ratio of the airline. The infused funds would be used to clear the dues of oil companies, airport operators and payment of employee’s salary. According to industry sources, it is believed that the airline’s debt-equity ratio will improve from 1:13 to 1:6.5. Read More

  • Technology, Media & Telecom
    TRAI gets government nod to act as Civil Court

    The Communications Ministry has cleared the proposal to grant more powers to TRAI and enable it to act like a civil court, like Securities Exchange Board of India and Competition Commission of India. This will empower TRAI to summon persons, examine them on oath, demand documents and evidence on affidavits and even call for expert assistance for conducting enquiries. It is expected that the new powers of TRAI will be clearly provided in the National Telecom Policy 2012. The decision on the power to penalize operators is still not clear. TRAI has been recently entrusted with the task of managing spectrum – the radio frequencies on which the mobile communication signal travel. Read More

  • Food & Pharma
    Union Budget 2012-13 to encourage pharma companies to invest more in R&D

    The Finance Minister in the Union Budget 2012 has proposed to extend the tax exemption for in-house R&D by another 5 years to 2017 to encourage pharmaceutical companies to invest more in R&D. At present, companies engaged in certain businesses are eligible for a tax deduction of 200 percent on certain expenditure incurred by them on in-house R&D facility. This deduction was to expire on March 31, 2012. The pharma industry had demanded extension not only due to the importance of innovation but also because the implementation of the Direct Tax Code, the new proposed legislation that will replace the existing Income Tax Act & Rules, has now been delayed. Read More

  • Food & Pharma
    Implement the Schedule Y-1 and Drugs and Cosmetics (Fourth Amendment) Rules, 2011

    Recently, two cases about the trial of drug Tadalafil in a hospital at Indore and the trial of an anti-cancer drug by Axis Clinical Research, Hyderabad, came to the notice of the DCGI that allegedly flouted the clinical trial norms. In the first case, the DCGI initiated action at Maharaja Yashwant Rao Hospital and Mahatma Gandhi Memorial College, Indore where the drug Tadalafil was used for clinical trial for Pulmonary Arterial Hypertension (PAH). The study with Tadalafil was initiated on September 18, 2005 when the drug was not approved for the said indication but for male erectile dysfunction on June 10, 2003. In view of this, the clinical trial of Tadalafil in Pulmonary Arterial Hypertension was stopped and the doctors were restricted to conduct any clinical trial for a period of six months. The trial of an anti-cancer drug by Axis Clinical Research on poor people was initiated without procuring proper informed consent. The investigations revealed that the firm conducted bioequivalence study on an already approved anticancer drug and there were certain irregularities with respect to informed consent process, review and decision making process of Ethics Committee. Read More

  • Aviation
    International routes: AI may lose special privilege

    AI’s monopoly over bilaterals, or international flying rights under the bilateral air service agreements may come to an end. The Ministry of Civil Aviation (“MoCA”) has scrapped with the special “Right to First Refusal” privilege enjoyed by the state-owned carrier almost a decade after private domestic airlines were allowed to fly overseas. This would free up foreign flying rights and routes typically reserved for Air India which were not being utilized and which could not be operated by the private carriers. The carrier has, until now, enjoyed exclusive rights over foreign routes due to its historic monopoly over international routes, meaning private airlines could operate only when AI said it would not operate on them. Under the new arrangement, allocation of the traffic rights will be done well in advance up to a maximum limit of five schedules considering the demands, capacities, operational plans and other relevant factors. The concept of “code sharing” under the new arrangement will also be promoted. Read More

  • Technology, Media & Telecom
    Government to form new body to oversee telecom and cyber security

    The government is planning to set up a new body NTNSCB, that will oversee telecom and cyber security to avoid overlap between various ministries and intelligence agencies that are currently handling this issue. The NTNSCB shall be located in the communications ministry and headed by the telecom secretary. NTNSCB will have representatives from the defense and home ministries, intelligence agencies, IT department, intelligence bureau, national security advisor and NTRO, among others. The NTNSCB shall suggest measures to address network security related issues, set up objectives and targets to the various departments and agencies handling telecom and cyber security related issues. The Centralized Monitoring System (“CMS”) and the secured network have been initiated by the government to strengthen monitoring of mobile, internet and other forms of communications in India. CMS aims at monitoring all communication traffic, wireless and fixed line, satellite, internet, e-mails and VoIP calls. Read More

  • Food & Pharma
    Draft guidelines on requirement of chemical & pharmaceutical information before approval of trials/BE studies

    On December 21, 2011, the CDSCO issued another guidance document for industry on “the Requirement of Chemical & Pharmaceutical Information including Stability Study Data Before Approval of Clinical Trials/BE Studies.” The draft guidelines apply to approval of clinical trial and BA/BE study of various categories of new drug formulations which are considered as new drug as per Rule 122E of Rules. However, these draft guidelines do not apply to biological and vaccine related clinical trials. The draft guidelines are based on regulatory requirements for approval of clinical trial of new drugs in India and detail the licence to be obtained by a manufacturer from the concerned state licensing authority based on NOC obtained from CDSCO for manufacturing trial batches of new drug for clinical trials in India. The CDSCO has mentioned that at present the draft guidelines have been published for feedback purposes only and it has invited comments and suggestions regarding these draft guidelines from the various stakeholders until January 20. The CDSCO after reviewing the comments received may issue a guideline on this aspect for the industry. Read More

  • Aviation
    GoM gives nod to 49% FDI in civil aviation

    Pursuant to the cash strapped aviation industry, the government is all set to give nod to the foreign airlines to invest in domestic carriers. The Finance Minister and the Aviation Minister decided that it will soon launch the process to allow foreign airlines to have 49% stake in the Indian carriers. At present, foreign airlines are barred from investing in Indian carriers, though foreign direct investment is allowed.

    PSA’s view:  The move comes nearly two months after Prime Minister Manmohan Singh assured the country that he will find ways and means to improve the airlines overcome their financial turmoil. The Cabinet will have to approve this major policy shift which when approved will allow foreign airlines to pick up stake in Indian carriers. Once, this proposal gets the Cabinet approval, it would be interesting to analyze whether foreign airlines would at all want to invest in Indian carriers, most of which are in poor financial shape. Read More

  • Technology, Media & Telecom
    Directions for green communication

    As part of the global initiatives to contain emissions of greenhouse gases and with a view to reduce carbon emissions in the telecom sector, TRAI had, in April 2011, given its recommendations on “Approach Towards Green Telecommunications”. Government has accepted these recommendations and directions have been accordingly issued to service providers on January 04, 2012. The highlights of these directions are: (i) At least 50% of all rural towers and 20% of the urban towers are to be powered by hybrid power (Renewable Energy Technologies (“RET”) + Grid power) by 2015. Further 75% of rural towers and 33% of urban towers are to be powered by hybrid power by 2020; (ii) All telecom products, equipments and services in the telecom network should be certified “Green Passport” by the year 2015. Telecommunication Engineering Centre will certify telecom products, equipments and services on the basis of ECR ratings; (iii) All service providers should declare to TRAI, the carbon footprint of their network operations. The declaration of the carbon footprints should be done twice in a year; (iv) Service providers should adopt a voluntary code of practice encompassing energy efficient network planning, infra-sharing, deployment of energy efficient technologies and adoption of RET to reduce carbon footprints; (v) Service providers should evolve a “Carbon Credit Policy” in line with carbon credit norms with the ultimate objective of achieving a maximum of 50% over the carbon footprint levels of the Base Year (2011) in rural areas and achieving a maximum of 66% over the carbon footprint levels of the base year in urban areas by the year 2020; (vi) Service providers should aim at carbon emission reduction targets for the mobile network at 5% by the year 2012-2013, 8% by the year 2014-2015, 12% by the year 2016-2017 and 17% by the year 2018-2019. Read More

  • Technology, Media & Telecom
    Telemarketer registration

    Early in 2011, the Telecom Regulatory Authority of India (“TRAI”) had released the Telecom Commercial Communications Customer Preference Regulations, 2010 for registration and regulation of telemarketers, both existing and new. The main objective of this regulation was to ensure that consumers do not get promotional communication from commercial or other establishments unless they have specifically opted for receiving them. Once the registration process is commenced, advertisers and commercial establishments will only be able to utilize the services of a registered telemarketer, and this will also allow a close monitoring so that the use of telemarketing is done only to reach customers who have opted to be solicited by such calls. The registration process calls for the telemarketer (which can be a firm, company or individual) to provide a few details such as PAN number etc. and contact address, the purpose of which presumable is to ensure compliance with the regulations. This is a novel method for regulating solicitation calls going to individual consumers to provide services and is now recognized as a media to reach the consumers, apart from print and television. Read More

  • Food & Pharma
    Bar codes on Indian medicines to curb fake

    Early in 2011, the Drug Consultative Committee (“DCC”) had approved the proposal for every strip of medicine in India to have a 2D bar code and a unique randomly generated numeric code. The proposal came into effect on October 1, 2011 and as per this proposal, it become compulsory that a phone number be mentioned above the bar code allowing a consumer to SMS the code to verify the authenticity of the  medicine by receiving a returning SMS. However, it seems that the implementation of barcoding on secondary level packaging has run into deep waters. The Madras High Court has ordered a stay on the implementation of barcoding, which means that until further notice, the exporters are not required to implement barcoding on secondary level packaging. Read More

  • Aviation
    Rolls Royce and HAL to set up aero engines production facility

    HAL and British aero engines manufacturer Rolls Royce have commenced construction of a new joint venture manufacturing facility in Bangalore, where components of civil aero engines, marine and energy gas turbine will be produced. The proposed production facility which will be about 7,200 square meters in size is owned by International Aerospace Manufacturing Private Limited, a joint venture company formed in the year 2010 by HAL and Rolls Royce. The facility will start production of aero engines and marine gas turbines by 2012. Read More

  • Aviation
    Government to set up National Aviation University

    India might have a National Aviation University for bridging the gap of demand and supply of skilled labour in the aviation industry. The Ministry of Civil Aviation has set up an expert committee to make the project report for the proposed university. The proposed university will undertake to train the youth; will make the Director General of Civil Aviation independent both administratively and financially. The university would also formulate an independent accident investigation bureau along with the inception of ombudsman to cater passenger concerns. Read More

  • Food & Pharma
    Clinical trials in India and its Registry

    From June 15, 2009, the Union health ministry made it mandatory to register all clinical trials conducted in India with the CTRI which was set up by the National Institute of Medical Statistics, a wing of the Indian Council of Medical Research as a registry of clinical trials approval. Since then more than 2000 clinical trials have been registered with them as against the 298 clinical trials registered during the two years before the registration was made mandatory. In order to improve transparency and accountability, registration is required with full disclosure of the 20-item WHO ICTRP dataset and the CTRI dataset. This also improves the internal validity of trials with details of the methods of the trial that produce reliable results, primarily the method of random sequence generation, concealment of allocation, blinding of participants and investigators, and inclusion of all participants results. This helps to accepted ethical standards and reporting of all relevant results of all clinical trials in India. Recently a team of pharmacologist in Andhra Pradesh conducted a study on the clinical trials on paediatric subjects and raised serious concerns regarding “selective reporting” to the CTRI. In selective reporting companies tend to report only the positive results while adverse results are often kept under cover. Read More

  • Food & Pharma
    Clinical trials on minors

    Recently a team of pharmacologist in Andhra Pradesh conducted a study on the clinical trials on paediatric subjects. More than 500 clinical trials were examined by the team. They concluded that a majority of pharma companies and hospitals conducting clinical trials in the country fail to observe ethical aspects like consent from minors involved in the clinical and post-trial obligation. Essentially, Schedule Y of the Drugs and Cosmetics Rules (“Rules”) provide that the paediatric subjects are legally unable to provide written informed consent and are dependent on their parents/legal guardian to assume responsibility for their participation in the clinical studies. Therefore, the consent to participate in the clinical trials has to come from the parent or legal guardian and they sign the written informed consent for the paediatric subjects. The Rules further provide that mature minors and adolescents should personally sign and date a separately designed written assent form. However, which age group shall constitute mature minors is not defined. The study team suggested that consent should be taken from children if they are above seven years of age. As the companies conducting trails prefer to conduct trial on illiterate and poor patients, which can be assumed as exploiting the situation of the poor, it also observed that disease to be explored in clinical trials by pharmaceutical companies was not based on healthcare need of that particular region. The team noted that informed consent was taken in 67.5% clinical trials. Assent taken from children was not mentioned in any clinical trial although 8.6% clinical trials studied related to childhood diseases. Read More

  • Technology, Media & Telecom
    Tightening noose on unsolicited calls

    Recently, the TRAI drafted the Regulations to regulate unsolicited commercial communications and has prescribed a limit of 100 SMS per day per SIM for all the customers. Before this, the telecom service providers offered 2000 SMS per day packages. The regulations provides that no access provider shall provide any tariff plan or SMS package in any form to any person other than a registered telemarketer permitting sending of more than one hundred SMS per day per SIM except on ‘blackout days’ and additional days as may be specified by TRAI. The transactional messages do not fall within the purview of transactional messages such as from a bank to its customers or from Airlines to its passengers, and likewise from the schools to the students/parents. There is a time restriction of 9 pm to 9 am for sending SMS which again do not apply to transactional messages. There are certain exclusions from the limit of one hundred SMS per day per SIM for the dealers of the telecom service providers and DTH Operators for sending request for electronic recharge on mobile numbers, e-ticketing agencies for responding to e-ticketing request made by its customers, the social networking sites to its members pertaining to activities relating to their accounts based on their verifiable options and agencies providing directory services. Read More

  • Aviation
    Financial restructuring of Air India

    A proposal for financial restructuring of Air India would be discussed at the meeting of GoM along with Air India seeking government approval for its fleet expansion plan till 2020. The restructuring and turnaround plans, would be vetted by a Committee of Secretaries, and would then be placed before the GoM. The restructuring plan would also include a proposal for converting its high interest debt to low interest ones and the issuance of a letter of comfort for its lenders (i.e. banks and financial institutions). The letter of comfort is likely to be issued to ensure that banks and financial institutions do not classify Air India’s loans as non-performing assets. Read More

  • Aviation
    DGCA to phase out ex-pat pilots by 2013

    Due to increasing pressures from Indian pilots’ bodies and associations, the DGCA is considering measures for reducing the number of ex-pat pilots employed by airlines in India. As for March 2011, approximately 350 ex-pat pilots were employed with airlines in India. The primary grievance of the Indian pilots’ bodies vis ex-pat pilots is that there is no parity in the remuneration packages offered. In addition to this, when airlines retain foreign pilots, who are employed primarily as flight commanders, the career progression of the Indian co-pilot halts, i.e. the co-pilot who is eligible to be trained and promoted as commanders stagnates as a co-pilot. As a fallout of this, airlines seldom have openings for co-pilots which leaves numerous commercial pilot license holders in the lurch and unemployed. Read More

  • Technology, Media & Telecom
    Sun TV comes clean from the competition commission’s scanner

    The CCI was recently investigating a complaint from the Informant under Sections 3 and 4 of the Act against Sun TV. According to the Informant, Sun TV was spending INR 4500 to acquire a single customer and was offering its services (DTH operations) for only INR 440 as a four month subscription fee along with a free set-top box. The Informant also alleged that Sun TV was charging subscription charges of INR 99/month which was less than the INR 156.55, i.e. the price prescribed by TRAI by a circular dated April 18, 2008. According to the Informant, such acts by Sun TV were eliminating competition for the Informant and other players who were also in the business of transmitting cable signals to the customers either directly or through local cable operators. The CCI met both parties on numerous occasions and held that a prima facie case existed for the director general (“DG”) to initiate investigation. The DG’s report concluded that the “relevant product market” for determining any contravention of the Act was only the DTH market since the services provided by other operators was not inter-changeable or substitutable with those provided by DTH operators. Read More

  • Food & Pharma
    CCI restrains AIOCD

    In a matter between Peeveear Medical Agencies in Kerala and the Mumbai based multinational company Janssen Cilag Pharmaceuticals, while passing an interim order under section 33 of the Competition Act, 2002, in favour of Peeveear on August 23, 2011, the CCI restrained AIOCD from issuing any direction or threat to Janssen to terminate its distributorship with Peeveear. The CCI passed the interim order and also instructed Janssen not to discontinue its distributorship with Peeveear. In the petition filed by Peeveear, it was alleged that AIOCD was exercising complete and absolute control over individual stockiest of drugs and medicines in the country bypassing from the power vested with it as per its Memorandum of Association which is essentially related to protection and promotion of the interests of persons engaged in drug trading industry and allied lines. Peeveear was appointed as the distributor of Janssen from March 2011 and it started sale of their products immediately after it. But, on April 26 the agency received an e-mail that supplies from Janssen would not be made to it for want of authentic documents to support the appointment of distributorship. Read More

  • Food & Pharma
    Guidelines on minimum requirements for diagnostics likely

    Industry Associations are in talks with the central government to establish minimum guidelines for the diagnostics industry. Due to the lack of regulation, the standards applied by public sector and private labs are quite drastically different and lacking in a few key areas. At present, accreditation is optional and not mandatory for laboratories. The sector is quite unregulated and considering the inflow of international tests being transferred to India for evaluation and diagnostics, there is a huge potential for error due to the lack of guidelines and regulations in this sector. Read More

  • Technology, Media & Telecom
    TRAI contemplating Cloud Computing regulation framework

    Quite recently, the TRAI has called for papers on the proposed regulatory framework for cloud computing in India. TRAI, in announcing the call for papers, showed its awareness of the growing phenomenon and the practical issues surrounding the same. TRAI has enumerated and highlighted several key areas of focus while calling for suggestions such as Regulatory framework for Cloud Computing, Ensuring high availability levels, Data erasing in the Cloud, Data privacy at Service provider end, Data Security, Data Export Restrictions, Monitoring Data Handling regulations required for Regulated Industries (financial services healthcare), Multiple Jurisdictions/Areas when data is stored at different data centers, Enhanced security Cloud Computing services, Ensuring quality of the Cloud service, Exit strategies and switching suppliers, Cloud Television/cloud computing on TV – levels of QoS, Inter-operable between Cloud Service Providers (common protocols), etc. Read More

  • Food & Pharma
    NPPA to start SMS service for sending brand name of drugs with prices

    The Government is in the process of rolling out a SMS service whereby which consumers can choose the cheapest brand of a drug prescribed by doctor by sending the brand name of a prescribed drug in a text message. The consumer shall receive a SMS from the NPPA listing out the brands of the same medicine along with their prices, thus providing an option to the consumer to choose the cheapest brand. The programme is being executed by the NPPA along with the department of pharmaceuticals. There is a significant difference in the price of the costliest brand of a medicine and its cheapest alternative. A recent survey by NPPA found that prices of the expensive brands can be ten times higher than the cheapest alternative of the same medicine. Read More

  • Aviation
    Airports to get Advanced Traffic Management System

    India’s Air Traffic Management System is all set for an overhaul with the implementation of the Auto Trac (AT) III system. Auto Trac (AT) III developed by US defence major Raytheon is a surveillance and safety Air Traffic System which helps in preventing flight delays by providing meteorological information apart from improving overhaul safety. This system carries meteorological information for air traffic controllers to help them adjust to changing weather conditions. This system is also fully equipped with a medium term conflict detection system which can determine aircraft’s flight path which would also help in preventing collision. At present, DGCA has installed this system at the Indira Gandhi International Airport in Delhi and are also planning to install in other congested airports located in Mumbai and Chennai. Read More

  • Food & Pharma
    Antibiotics policy brings Schedule HX to the Act

    The Ministry has completed drafting of the national antibiotics policy and will insert a new Schedule HX under the Act with a view to preventing the misuse of about 70 antibiotics. This draft has been sent to the Law Ministry before seeking approval of the Drugs Technical Advisory Board . The Drugs Consultative Committee had already given its go-ahead to the proposal. Currently the antibiotics are placed under the Schedule H of the Act. Antibiotics would be categorized as non-restricted, restricted and very restricted. Each category would have a distinct colour code for the benefit of consumers. The policy would include a list of antibiotics that cannot be sold without doctors’ prescription. The new Schedule HX that will apply to both public and private health sectors, will require doctors and chemists to retain prescriptions and doctors will have to give two prescriptions to every patient and one copy should be kept for a period of 2 years by the chemists. The Drug Controller General of India can audit it any time and violations will be punished with a fine of INR 20,000 or up to 2 years imprisonment. Read More

  • Technology, Media & Telecom
    New Telecom Policy to be released soon

    The new telecom policy is expected to be released by the end of this year. This policy will divide mobile permits into two categories, Network Service Provider (“NSP”) and End User Service Provider (“ESP”). NSP to provide all infrastructure for communication and broadcasting services while ESP to provide voice, data and broadcast services to the consumer. It may also do away with the existing rules on infrastructure sharing so that telcos can share hardware, software and even spectrum. The policy will replace the existing policy of 1999. The internal committee framing the policy has rejected the concept of allowing telcos to trade airwaves with other and said that government must be the final authority of awarding, selling and taking back airwaves. It has also proposed that a spectrum fund be set up to bear costs of farming of airwaves and compensating incumbent non-commercial users like government departments, police, para-military towards moving to more efficient bands. Read More

  • Aviation
    DGCA scraps special exam for pilot license

    The DGCA has scrapped the practice of holding special exams, and changes to this effect have been made in the Civil Aviation Requirement (“CAR”) relating to Flight Crew Standards. Thus, with this aspiring applicants who want to become pilots will have to clear all the pilot license exam papers only by appearing for regular exams that are held by the DGCA once in three months. Special exams were conducted in between the regular exam session. A candidate can apply to sit for a special exam, if he/she use to fulfill the list of criteria such as: the candidate should have cleared all the subjects, except one and cannot afford to wait for a regular exam session as the validity of their flying hours or that of other exam result would expire by then. Read More

  • Food & Pharma
    IAF to challenge THMPD

    By the THMPD, EU has banned all ayurvedic products in EU. Miffed over this step, the IAF is all geared up to initiate legal proceedings under Article 234 EC in the Courts of the UK challenging the legality of the THMPD. The basic arguments are as to how does the directive become a law since it is in contravention with lots of existing laws in EU, how EU is violating the European human rights legislation, and how EU is violating the existing protocol of WTO treaty through this directive.

    PSA view – It is crucial to challenge THMPD because if it remains unchallenged, chances of other countries replicating the same move may follow suit. The existing global ayurveda industry is estimated to be US$ 5 billion and THMPD like directives could be a disaster for the industry. The chances that such directives will lead to illegal use of ayurvedic products. Read More

  • Technology, Media & Telecom
    Applicability – The Rules apply to all body corporates

    The Rules apply to all body corporates that collect and use personal data and information in India, including the intermediaries acting on their behalf. Section 2(w) of the Act defines intermediary as a person that receives, stores or transmits electronic records on behalf of another person and includes telecom/network/internet/web-hosting service provider, the search engines, online payment, online auction and online market places, and cyber cafes.  It does not apply only to Indian citizens or residents or body corporate, but to any personal information collected within or outside India by body corporates. Read More

  • Aviation
    4,000 pilots licenses to be re-checked

    The DGCA has announced recently that it will undertake the task of scrutinizing at least 4,000 commercial pilots licenses that were issued in the previous year. In light of police investigations and the arrest of two commercial pilots, and two other suspected pilots absconding, the DGCA has now decided to investigate the commercial pilots licenses it has issued in the past year. In addition to this, the DGCA has also set up an expert committee to examine the current system of examination for pilots and engineers, in order to come up with recommendations for revamping the current examination system and licensing procedure. Read More

  • Technology, Media & Telecom
    TRAI proposes to make quote to promote local equipment

    In a bid to promote the domestic equipment manufacture, the TRAI has recently announced that it plans to provide a rebate on the telecom licensee fee. The TEMA has approached the TRAI to put in place a mechanism requiring operators to procure a minimum of 30% of their equipment requirement from local manufacturers. According to TEMA, this will help the local manufacturers come up to standard and compete with international equipment manufacturers. Opposing the TEMA’s demands, the Cellular Operators Association of India (“COAI”) on the other hand says that such a requirement will in fact make the local manufacturers complacent and they will be under no obligation to improve quality, however has expressed that the TRAI could incentivize procurement of locally manufactured equipment by providing a rebate on the license fee. Though the percentage of the rebate has not been announced by the TRAI yet, however it s determined to increase local equipment manufacture and procurement by telecom companies from 13% for FY 2009-2010 to 30% by FY 2012-2013. In order to thwart the practice of importing goods in semi assembled condition and just assembling the same in India to make it seem like manufacture, TRAI is looking at applying a value addition criteria. Under this, the TRAI will prescribe the percentage of the cost of the equipment that has the be procured from India, including raw materials and intellectual property. Any operator which does not fulfill the criteria of procuring a certain percentage of equipment from India will be required to pay the shortfall into a research fund or equipment manufacturing fund for the telecom sector. Read More

  • Food & Pharma
    Flavored water industry in a fix over regulation

    The flavored water industry in India is facing problems under the PFAR which regulates the packaging and manufacture of packaged drinking water. A Chennai based foundation named International Herbal Water Foundation (“the Foundation”) has written to the FSSAI highlighting the grievances of the industry and the specific problems faced by the industry under the PFAR due to lack of appropriate standards. Under the PFAR, flavored packaged drinking water is misunderstood by the implementing agencies as packaged drinking water which is then brought under the purview of Rule 49(28) of the PFAR which prohibits sale of such a product without a BIS certification mark. Further, packaged drinking water is defined under the PFAR as water to which no additives are added and which undergoes some special process for purification. Due to this, since there are additives in flavored water, many implementing agencies have shut down and sealed plants which has caused a substantial amount of fiscal losses to companies in this industry. Read More

  • Aviation
    Aviation Ombudsman in sight

    Despite attempts by air carriers to avoid appointment of any ombudsman in aviation, following the steep growth in the number of passengers and the issues emanating from the chaos of hike in fares last year, the government has finally firmed up plans for implementation of an ombudsman as a one-stop redressal mechanism and to act as an arbitrator to settle disputes against airlines or airports. At the outset, the quasi-judicial authority is intended to be in Delhi later this year with several aviation ombudsman at State level subsequently. Read More

  • Technology, Media & Telecom
    TRAI issues “Issues Related to Telecommunications Infrastructure Policy”

    Given the vigorous growth in the telecom sector and the urgent requirement of an apposite infrastructure for its sustainable growth, TRAI released on January 14, a consultation paper on “Issues Related to Telecommunications Infrastructure Policy.” On 5th February 2010, a pre-consultation paper was issued by the TRAI on issues relating to tower infrastructure for obtaining views of the stakeholders. Based on the comments received and further review of earlier recommendations, the scope of the current consultation paper has been enlarged to cover the entire gamut of telecom infrastructure to collectively discuss, debate and finalize measures required. The consultation paper takes up the following important issues for deliberations: (i) Telecom infrastructure classification and details with accent on policy issues that need to be consulted upon; (ii) Framework relating to Mobile Virtual Network Operators; (iii) Setting up of National Internet Exchange Points; (iv) Issues relating to telecom tower infrastructure and (v) Issues relating to Rural telephony, migration to IPv6 and IPTV. Read More

  • Food & Pharma
    Importing APIs from related parties at prices of local market!

    Recently, the Mumbai Income Tax Appellate Tribunal in Serdia Pharmaceuticals (India) Private Limited v. Assistant Commissioner of Income Tax held that the arm’s length price for importing Active Pharmaceutical Ingredients (“API”) from related enterprises should be determined on the basis of price at which locally manufactured generic API are sold in the domestic market. In this case, the tax payer had adopted Transactional Net Margin Method (“TNMM”) for determining the correct arm’s length price of the API which was imported into India. The IT Department contended that the APIs purchased were at prices that were higher than that paid for similar APIs by other companies in India and that the Comparable Uncontrolled Price (“CUP”) was the most appropriate method. The Tribunal held that the onus of selection of the “most appropriate method” for determining the arm’s length price of a transaction was on the tax payer. Since in the present case, the tax payer had failed to dispose this burden, the IT Department was justified in applying CUP Method without specifying the reasons for rejection of TNMM method. Finally, it held that whenever the CUP Method could be reasonably applied in determining the arm’s length price, this method should be followed. Read More

  • Food & Pharma
    Union Health Ministry makes it mandatory for pharma units to comply with the Good Laboratory Practices

    The Ministryhas made it mandatory for pharmaceutical units to comply with the GLP. The state drug controllers have been asked by the DCGI to begin implementation of the GLP from November 1, 2010. The decision to implement GLP was taken by the government in 2008 and the pharmaceutical industries were given a time period of two years to comply with GLP. Globally, countries require manufacturers of industrial chemicals, pharmaceuticals etc., to ascertain that the products being manufactured by them are safe for humans and the environment. The enforcement of GLP shall ensure that the products being manufactured are of non-hazardous nature and safe for humans and the environment. Read More

  • Technology, Media & Telecom
    Intelligent Network Services

    TRAI sent its recommendations on “Provision of Calling Cards by Long Distance Operators” to the Department of Telecommunications (“DOT”) that license conditions of the NLD and ILD license may be amended to allow NLDOs and ILDOs to have direct access to consumers, through calling cards, for provision of national and international voice telephony services, respectively. These recommendations were adopted, subsequent to which the NLDOs and ILDO became eligible to issue calling cards for NLD (STD) calls and ILD (ISD) calls. TRAI noted that Intelligent Network Services in Multi-Operator Multi Service Scenario Regulations, 2006 issued on November 27, 2006 (“IN regulations”) to facilitate the subscribers of an access provider to access the IN Services provided by any other service provider requires amendment. Accordingly, the Intelligent Network Services in Multi-Operator and Multi-Network Scenario (Amendment) Regulations, 2010 was issued. Regulations 10(2), (4) and (6) of the IN regulations give the provisions relating to time period of entering into agreement and submission of the same to the Authority. It has been noted that there is no specific time frame in the IN regulations for the service providers who become eligible to provide IN services subsequent to the date of issue of IN regulations. Read More

  • Aviation
    Bilateral Aviation Safety Agreement between India and USA soon

    The Directorate General of Civil Aviation (“DCGA”) and the Federal Aviation Administration (“FAA”) have initiated a bi-lateral process of certification of aeronautical products developed or produced in either India or the United States of America (“US”). This process will culminate into a Bilateral Aviation Safety Agreement (“BASA”) which will greatly facilitate trade in aero components and aeronautical products between the US and India. Two important activities towards achieving BASA that have been completed are (a) the technical assessment of DCGA by the FAA in eleven specific areas and (b) a shadow certification where the work done by the DCGA was reviewed by the FAA, and the FAA has so far been satisfied with the DCGA. Read More

  • Food & Pharma
    The Health ministry may not issue directive u/s 33P to SLAs on Spurious Drugs Act Guidelines

    In September 2010, the Union health minister announced that the Union Health Ministry (“Ministry”) would implement the Spurious Drugs Act by issuing a directive to the state drug authorities under section 33P of the Drugs and Cosmetics Act, 1940 (“Act”) under which it would be mandatory for the state drug authorities to follow the guidelines before executing the various provisions of the Spurious Drugs Act. Now, the Ministry is reconsidering this decision. It is planning to issue a general directive to the state drug authorities stressing the need to consult the guidelines attached to the Spurious Drugs Act before initiating any prosecution against the manufacturers for manufacturing and marketing spurious drugs. Read More

  • Food & Pharma
    Karnataka pharmaceutical

    Karnataka pharmaceutical wants state government to set up exclusive pharmaceutical park to encourage growth The Karnataka pharmaceutical industry wants the state government to set up an exclusive pharmaceutical park to help it achieve higher level of growth. Pharmaceutical industries, which require huge investments in setting up of comprehensive infrastructure, in Karnataka have been, over the years, struggling to control pollution and manage effluent treatment issues, etc. due to lack of proper infrastructure.

    PSA view: The industry has vast opportunities which are still to be tapped. In 2009-10, the pharmaceutical industry in Karnataka generated exports worth INR. 3,500 (US$ 772,534,537 approx.). The growth in the pharmaceutical industry in Karnataka has often been compared to that of Information Technology (“IT”) and biotechnology. To unleash the full potential of the pharmaceutical industry in Karnataka, the government needs to provide infrastructure, as it has done for the IT sector. Read More

  • Aviation
    Bail out likely for airlines to allow foreign debt to repay loans

    By a proposal raised by Reserve Bank of India (“RBI”) at the behest of a State Bank of India (“SBI”)-led consortium, the Department of Economic Affairs has called for exempting airlines from the end-use restrictions laid down for external commercial borrowings (“ECBs”) which would permit airlines to use foreign debt to repay loans to local banks.

    SBI which has granted loans to Kingfisher Airlines and NACIL had previously approached RBI in view of the ballooning debts of the cash-strapped carriers and their inability to service loans, and proposed loan structuring. The RBI had, instead of a special dispensation for selective airlines, preferred to move an industry-wise dispensation.

    Under the debt restructuring initiatives, the lenders have tentatively suggested a 2 year moratorium on short-term debt, better interest rate and conversion of a part of the debts into ECBs or cumulative convertible preference shares. Read More

  • Aviation
    DGCA sets up Civil Aviation Safety Advisory Council (“CASAC”)

    With a view to strengthen the aviation safety environment, the government has set up Civil Aviation Safety Advisory Council for a period of one year. CASAC is headed by the Director General of Civil Aviation (“DGCA”) and has members drawn from various aviation sub-sectors such as airlines (both public and private), flight operations, air worthiness, operations, to name a few. Additionally, representatives from ICAO, FAA, Boeing, Airbus and other organizations will also be periodically involved in its meetings.

    CASAC is advisory in nature. It will develop, examine and recommend incorporation of best regulatory practices, recommend short, medium and long-term measures for safety enhancement and reflect public views on aviation safety matters. Its role is to advise DGCA in areas of operations of aircraft, commercial and general aviation, aerodromes and heliports, air navigation services, air operator certification, airworthiness of aircraft, including maintenance, certification of aeronautical products, human performance and training. Read More

  • Food & Pharma
    National Policy for antibiotics in the offing

    India is set to have a policy on the rational use of antibiotics the need for which got heightened because of the recent “super bug” study on antibiotic resistance that stirred a hornet’s nest. In a recently concluded study on the ‘Emergence of a new antibiotic resistance mechanism in India, Pakistan and the UK’ published in an online edition of the Lancet Infectious Diseases, the drug-resistant “super-bug” strain of bacteria was traced to New Delhi, and even cautioned people coming to India for medical tourism. Read More

  • Technology, Media & Telecom
    Implementation of Digital Addressable Cable TV Systems

    TRAI released the recommendations on Implementation of Digital Addressable Cable TV Systems in India and the framework of implementation by December 2013. TRAI’s recommendation discusses the nature and limitations of the broadcasting sector, different types of cable TV systems viz. analogue, hybrid and fully digital systems along with the inherent features and limitations of the analogue cable TV system. It further analyses various issues connected with the implementation of digitization with addressability in the cable TV sector, including the basic need for digitization, technology/standards, investment involved, incentives to stakeholders for implementing digital addressable systems, required amendments to the Cable TV Act, licensing of MSOs/LCOs and the need for an awareness programme for education of stakeholders. It further describes the roadmap for implementing digitization with addressability in a phased manner. Read More

  • Technology, Media & Telecom
    Cloud computing services from India

    Soon Google’s cloud computing initiative will be led by its centre’s in Bangalore and Hyderabad. With several million businesses and active users globally, Google aims at developing India as a “Centre of Excellence” for the company in cloud computing. This in-turn will translate Google India as the largest enterprise development centre of the company.

    PSA view – This will definitely generate further employment and strengthen India’s position as a global IT service provider. However, it will also divulge the existing loopholes in India’s Information Technology Act, 2000 (“Act”). Cloud computing is a shift from the usage of hardware and software to store and use data, to online storage and usage of data on a computing platform run by a third party, such as Google, Yahoo, Amazon, etc. Its per-use service-based model benefits businesses by lowering costs and performing efficiently. However, there are several legal issues, such as data protection, jurisdiction and electronic evidence revolving around it. Cloud computing service from India will provide a stringent test to the existing Act. To withstand such test, the legislators will have to fine tune the Act to curb violations and place stringent penalty on the offender. Necessary steps will also have to be taken to provide clarity on multi-jurisdictional issues and the procedure for obtaining electronic evidence from the service provider. Since such measures are not in place, it is to be seen how the legal issues arising from cloud computing services are resolved, and the view of the judiciary towards it. Read More

  • Food & Pharma
    Monographs for Radioceuticals to be added soon

    The Indian Pharmacopeia Commission (“IPC”), which is an autonomous institution under the Ministry of Health & Family Welfare, has initiated efforts to include monographs of radiopharmaceuticals, which are used in the field of nuclear medicine, as tracers in the diagnosis and treatment of various diseases including cancer, in India for the first time. The IPC, after holding a meeting in July 2010, plans to add a general chapter covering approximately 25 monographs of radiopharmaceuticals which are widely used for diagnostic and therapeutic use in India. The commission has formed an expert committee consisting of eminent scientists from the field and is expected to complete its job within a period of six months. The IPC proposes to publish the general chapter on radiopharmaceuticals in the 6th edition of Indian Pharmacopeia under the Second Schedule of the Drugs and Cosmetics Act, 1940. Read More

  • Technology, Media & Telecom
    A consultation paper on “National Broadband Plan” released

    With the intention of making the broadband services available at affordable tariff, provide access to enormous information, facilitate delivery of civic services, increase GDP contributions, generate more employment and enhance productivity, TRAI issued a consultation paper on “National Broadband Plan”. The Department of Telecom has also made a reference to TRAI seeking its recommendations on the need to review the definition of broadband connectivity in view of future growth in internet/broadband driven by wireless technologies. The net broadband addition per month is just 0.1 to 0.2 million and the facility is limited to metro and major cities only. The low broadband penetration in rural areas is attributed to non availability of transmission media connectivity up to village level. Read More

  • Technology, Media & Telecom
    The e-waste (Management and Landling) Rules, 2010 released

    A draft e-waste (Management and Handling) Rules, 2010 (“E-Waste Rules”) was released by the Ministry of Environment and Forests in exercise of the powers conferred in sections 6(2)(c) & (d), 8 and 25 of the Environment (Protection) Act, 1986. The E-Waste Rulesdefines“e-waste” as “waste electrical and electronic equipment, whole or in part included in, but not confined to equipment listed in schedule-I and scraps or rejects from their manufacturing process, which is intended to be discarded.” The E-Waste Rulesshall apply to every producer(s), dealer(s), collection centre(s), refurbisher(s), dismantler(s), recycler(s), auctioneer(s), consumer(s), or bulk consumer(s) involved in the manufacture, sale, purchase, and processing of electrical and electronic equipment or components. Read More

  • Food & Pharma
    Expect amendment in the Drugs and Cosmetics Act to curb pharma companies from giving freebies

    Under the regulations (as recently notified by the Medical Council of India (“MCI”), only doctors accepting gifts from pharmaceutical companies are liable to be penalized. The pharma companies who give such gifts are beyond the scope of law. The MCI is now keen to check this practice (mal). MCI’s proposal to the Union Health Ministry to amend the Drugs and Cosmetics Act to bring the pharmaceutical companies under the purview of law, by making them punishable for rolling out freebies to doctors for promoting their medicines, will soon be a deterrent for pharma companies. Indulging in such unethical trade practices may lead to cancellation of licenses of the pharma companies. Read More

  • Technology, Media & Telecom
    Consultation paper released by TRAI

    (A)    Interconnection and Tariff issues related to HITS services
    The TRAI released a consultation paper on “Interconnection and Tariff issues related to HITS services.” The guidelines for providing Headend-In-The-Sky (“HITS”) broadcasting service in India have been issued by the Government on November 26, 2009. The Ministry of Information and Broadcasting has requested TRAI to revisit the interconnection regulations and issue tariff orders for promotion of HITS services. This consultation paper intends to seek the views of the stakeholders on issues relating to amendments to the interconnection regulations and tariff dispensation for HITS services in India. Read More

  • Food & Pharma
    Budget highlights 2010 -2011
  • ECBs to be allowed for cold storage facilities including farm level pre-cooling.
  • A bill providing for establishment of “National Biotechnology Regulatory Authority” (“NBRA”) is expected to be introduced soon in the Parliament. The NBRA would regulate the research, manufacture, importation and use of genetically modified organisms and products derived thereof.
  • New duty rates: Read More
  • Technology, Media & Telecom
    Mobile Number Portability (Amendment) Regulations, 2010

    TRAI has amended the Telecommunication Mobile Number Portability Regulations, 2009 (Regulation) dated September 23, 2009 laying down the basic business process framework for implementation of mobile number portability (MNP) in India by a notification dated January 28, 2010 and enacting Mobile Number Portability (Amendment) Regulations, 2010. The government has decided to extend the time for implementation of the Regulations to March 31, 2010, for all circles. Out of the 14 Regulations, the following were to be implemented on December 31, 2009 – 6 (Procedure for porting), 7 (Grounds for rejection of porting request by Donor Operator), 8 (Rights and obligations of Donor Operator), 9 (Rights and obligations of Recipient Operator), 10 (Rights and obligations of MNP Service Provider), 11 (Rights and obligations of Mobile Telephone Service Providers), 12 (Obligations of Access Providers, National Long Distance Operators and International Long Distance Operators) and 13 (Reversal of number due to disconnection). Read More

  • Food & Pharma
    Pricing rules for drug imports relaxed

    The National Pharmaceutical Pricing Authority has eased the norms for pricing of imported drugs in India allowing companies to seek approval once in six (6) months. This is a shift from the previous practice wherein the pharmaceutical companies in India were required to submit report to the NPPA on every imported consignment of drugs and seek their approval for pricing in the domestic market. The eased norms will also be applicable to bulk drugs and other intermediate chemicals.

    PSA view With a single approval for six months, pharmaceutical companies will be able to import any number of consignments and sell it in India without seeking any fresh approvals. This change will definitely reduce the procedural delays associated with pricing of imported medicines. The retail price of formulation is calculated per the formula provided in Order 7 of the Drugs (Prices Control) Order, 1995. Accordingly, in the case of an imported formulation, the landed cost is the basis for fixing its price along with such margin to cover selling and distribution expenses including interest and importer’s profit. Read More

  • Technology, Media & Telecom
    SC directs TRAI to fix cable TV tariffs for non-CAS areas

    On January 18, 2010, the Supreme Court of India (“SC”) directed the Telecom Regulatory Authority of India (“TRAI”) to complete the process involved in fixing tariffs for cable television for non-Conditional Access System (“CAS”) areas by June 30, 2010. For this tariff fixation process, TRAI will have to consider the views of all stake-holders in the industry. TRAI will also have to look at the entire cable television market while determining tariffs since the content provided by broadcasters is the same for the CAS, non-CAS and even Direct-To-Home (“DTH”) platform.

    PSA view – Since the cable television market in India is extremely fragmented and caters to nearly 80 million subscribers, it is imperative that TRAI formulates guidelines for fixing cable TV tariffs for non-CAS as well as DTH areas. Non-CAS areas are those areas where the pay channels are transmitted in unencrypted formats and, therefore, the ultimate consumer does not have the freedom to choose his channels, but has to pay for all channels transmitted by the cable operator. It is essential that TRAI takes a holistic view of the market since the cost of content production is the same for the CAS, non-CAS and DTH platform. The fixation of tariff, coupled with the Standards of Quality of Service (Broadcasting and Cable Services in non-CAS Areas) Regulations of 2009, enforced by TRAI since April 2009, will certainly help in reducing the quality and pricing gap between CAS and non-CAS areas. Read More

  • Food & Pharma
    Draft Food Regulations have been released for consultation

    The Draft Food Safety and Standards Rules, 2009 (“Rules”), Draft Food Safety and Standards Regulations, 2009 and the Annexure (“Regulations”) have been released by the Food Safety and Standards Authority of India (“FSSAI”). The Food Safety and Standards Act, 2006 (“Act”) was passed by the Parliament with the intention to converge all present food laws into one and to have a single regulatory body. Accordingly, FSSAI was established under the Act with the mandate to lay down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale, and import, to ensure availability of safe and wholesome food for human consumption.

    The Draft Rules have been prepared in consultation with various stake holders and after thorough deliberations in a series of meetings in the FSSAI. The Rules include qualification of the enforcement agencies, manner of sampling, determination of cases for referring to appropriate courts, time frame for such determinations, procedure to be followed in adjudication of cases, qualification of the Presiding Officer of the Tribunal and rules on other issues enumerated under section 91 of the Act. The Regulations broadly reproduces the Prevention of Food Adulteration Rules, 1955 and contains separate Annexure for appendix A, B, and C which includes standards for food colour, list of additives and microbiological requirements etc., which have been reproduced from the rule without any change. Read More

  • Food & Pharma
    SEZ benefits for Food Parks

    The Government is proposing to extend benefits of Special Economic Zones (“SEZ”) to food parks to promote India as a hub for food processing. SEZ benefits are currently available only to SEZ Developers and units. Mega Food Park Scheme presently operates under different set of guidelines framed by the Government. In the 11th Plan, the Ministry of Food Processing approved a new scheme to establish thirty (30) Mega Food Parks with a view to provide state-of-the-art infrastructure for food processing sector in the country on a pre-identified cluster basis with a strong backward and forward linkage and to provide value addition of agriculture commodities including poultry, dairy, etc. in a demand driven manner. The ownership and management of the Mega Food Park would vest with a Special Purpose Vehicle in which organized retailers, processors, service providers, farmer groups etc. may be the equity holders. The products of the Food Processing Industries located in a Mega Food Park can be sold to domestic as well as export market. Read More

  • Technology, Media & Telecom
    External Commercial Borrowings (“ECB”) for spectrum in the Telecommunication sector

    The Reserve Bank of India issued an A. P. (DIR Series) Circular No 19 dated December 9, 2009 and made certain changes in the ECB policy for the telecommunication sector. As per the present policy, payment for obtaining license/permit for 3G spectrum is considered an eligible end-use for the purpose of ECB under the automatic route. It has now been decided to permit with immediate effect the eligible borrowers in the telecommunication sector to avail ECB for the purpose of payment for spectrum allocation as well. However, the other aspects of ECB policy such as USD 500 million limit per company per financial year under the automatic route, eligible borrower, recognized lender, end-use, average maturity period, prepayment, refinancing of existing ECB, reporting arrangements and terms and conditions stipulated in the previous A. P. (DIR Series) Circulars shall remain unchanged. Read More

  • Food & Pharma
    Policy for Nutraceuticals to be out by December, 2009

    The Food Safety and Standards Authority of India (“FSSAI”) plans to introduce the policy on Nutraceuticals in India by December 2009. Nutraceuticals are dietary supplements meant to fill nutritional deficiencies in food and are divided into functional foods, functional beverages and mineral supplements. Currently, nutraceuticals and food supplements are neither classified as food nor as drug for licensing purposes in India .

    PSA view – Though nutraceuticals have been in the market for almost a decade in India , there was no regulatory system or monitoring process in place for them. Lack of effective regulations resulted in unsubstantiated medical and legal claims and confusion in the minds of stakeholders. With the introduction of the Nutraceutical policy, the hitherto unregulated area will certainly benefit the pharma companies, the nutraceutical market, and most of all the consumers. Read More

  • Technology, Media & Telecom
    TRAI to give suo-moto recommendations on license fee

    Pursuant to the Department of Telecommunication’s (“DOT”) decision to replace the existing variable license fee structure with a uniform one for telecom operators, the Telecom Regulatory Authority of India (“TRAI”) decided to issue suo-moto recommendations to the DOT in fear that such change of norms may impact the government’s revenue. The uniformity in license fee was suggested by the operators to help avoid arbitrage over integrated operators allegedly loading up maximum revenues on licenses with lower fee. Presently, the operators pay between 6-10% of their annual revenue to the government as license fee, contingent upon the type of service procured. However, media sources speculate the “new” uniform fee to be 8.5% for all types of services. Read More

  • Food & Pharma
    Labeling of Genetically Modified (“GM”) foods

    The newly set up autonomous Food Safety and Standards Authority (“FSSA”) has been entrusted with the responsibility to draft the mandatory labelling guidelines for the GM food in India by the Union Health Ministry. FSSA shall consider the recommendations of the committee of experts and stakeholders constituted by the Union Health Ministry, which had unanimously recommended mandatory labeling of all GM foods irrespective of the threshold level in March 2009.

    PSA View – Under the Food Safety and Standards Act, 2006, the FSSA has powers to regulate GM food. Before this, the Genetic Engineering Approval Committee, which had exclusive powers to regulate all GM products under the Environment Protection Act, 1986 and Rules, 1989, has so far made no suggestions or drafted any guidelines. The annual amendments to the Foreign Trade Policy made in April 2006 had said that unlabelled GM products import would attract penal action under Foreign Trade (Development and Regulation) Act, 1992. This will help in smooth trade of GM foods in India. Read More

  • Food & Pharma
    New R&D Policy for Food Processing Industry

    The Ministry for Food Processing Industries (“MFPI”) is contemplating a new policy for promoting Research and Development (“R&D”) in the food processing industry. The new policy will primarily stress on the development of private public partnerships for R&D in this sector.

    PSA view – There is a need for the development of new cost-effective methods for food preservation and packing and this policy initiative taken by the MFPI is a step in the right direction. The rationale for this policy is to build capacity, both of technology and food processing capabilities, and foster increase in the processing of perishable food items and raise the value addition of agricultural produce. As the MFPI has also announced that certain fiscal benefits would be attached to companies that undertake such R&D projects, this sector is likely to see a drastic increase in participation. Read More

  • Food & Pharma
    Make no error! – Mandatory registration of clinical trials in India

    It is mandatory for all pharmaceutical companies planning to undertake clinical trials in India to register with the Indian Council of Medical Research Clinical Trial Registry. The hitherto optional registration has been made compulsory by the Directorate General of Health Services with effect from June 15, 2009.

    PSA view – In light of the increasing number of adverse events, malpractices, trials by small unknown companies/hospitals, mandatory registration will ensure transparency, accountability and accessibility of clinical trials and their results to public and will also, to an extent, streamline the entire process from start to finish. Read More