The Food and Pharmaceutical team is equipped and possesses diverse experience in assisting clients with a wide range of issues. Working closely with the Regulatory and the Labour and Employment group, the lawyers give advise on the necessary regulatory issues relevant in the formation of food processing units including licensing, securing approvals under the labour laws for a manufacturing unit, packaging standards & norms, and several other aspects arising from various regulations related to the food sector such as Food and Safety Standards Act, Standards of Weights & Measures Act and Rules and Bureau of Indian Standards.
In the pharmaceutical sector, our team has counseled clients in setting up manufacturing units in India for pharmaceutical companies and R&D units in Special Economic Zones. The experience also includes counseling in establishment, taxation, labour and IP issues related to all classes of wellness industry, including alternative therapies, beauty, counseling, fitness and slimming, nutrition and rejuvenation. Together with the IP team, the lawyers also counsel clients on IP infringement of pharma products, dietary supplements, proprietary medicines, Drug and Cosmetics Laws, Good Manufacturing Practice requirements. The team has counseled and represented clients on diverse issues ranging from governing laws for drafting pricing policy for medical devices to laws on vaccination in India and legal requirements for pursuing medical internship programs by foreign medical students in Indian hospitals.
Our lawyers possess extensive knowledge on clinical trial regulations in India, representing pharmaceutical manufacturers engaged in conducting clinical trials in India which is becoming a favorite destination for numerous global pharma companies. The lawyers have drafted, reviewed and negotiated several clinical trial contracts (both sponsor and investigator initiated), SOPs for numerous multi-national pharmaceutical companies. The experience also involves counseling clients on the prevailing clinical trial laws, as well as issues emanating under contract law, working with contract research organizations, and interfacing with the Ministry of Health and Welfare as well as the other regulators including the Drugs Controller General of India. The firm possesses the necessary pragmatic experience, skills and knowledge of good clinical practices (in Indian and other jurisdictions) and provides advise so that the clinical trials are conducted in accordance with the law, policy and best industry practices.
The lawyers have :
- Represented and advised a top pharmaceutical company on the governing laws for drafting an appropriate pricing policy for their broad range of medical supplies, devices, laboratory equipment and diagnostic products both manufactured and imported into India and the packaging and labeling laws governing them;
- Assisted a French pharmaceutical company to establish, launch and operate its Indian business including obtaining marketing authorizations;
- Advised a Europe-based distributor regarding import and distribution requirements in India for pharmaceutical products;
- Advised clients on the regulations, guidelines and policies in respect of vaccination and immunization in India;
- Assisted clients in establishment of an ayurvedic & proprietary medicine manufacturing unit;
- Drafted license agreements, employment agreements, and policy documents for creation of national franchise network of medical services in a social welfare project promoted by an Indian multinational company;
- Advised one of the world's leading pharmaceutical companies on the regulations governing clinical trials in India, gave extensive opinions on the roles and liabilities of the various participants in a clinical trial study;
- Provided strategic advice in clinical trial holds imposed by the regulatory authorities, and advised the clients on legal aspects (including privacy issues of the subjects) with an intent to assists the client to have the hold removed and continue with the clinical trial;
- Drafted, reviewed and negotiated several clinical trial contracts, SOPs for and on behalf of numerous multi-national pharmaceutical companies and investigator initiated studies;
- Advised a leading European pharmaceutical company in respect of contractual principles to be considered while drafting clinical trial and non-disclosure agreements in the Indian context;
- Advised an American pharmaceutical company regarding data protection regulations prior to initiation of clinical trials;
- Represented a US multinational company in forming a joint venture with an Indian pharmaceutical company for manufacture of proprietary and herbal products;
- Advised Italian food manufacturer regarding test-level marketing, assisted in selection of importers who will sell the Italian products in India;
- Provided legal advice to companies on launch of foreign bottled wines in the Indian market, detailing various trade issues including the duty structure, import-export norms, as well as licences for wine business in different states of India;
- Counseled clients on diverse IP issues including branding and copyright issues in the description of products related to food items like pasta, wine, fruit juices, and olive oil;
- Counseled a US-based seller of its Class I and Class II medical devices regarding labelling and packaging issues in India;
- Advised an Indian subsidiary of a global food products' conglomerate on a number of issues in the context of food adulteration, packaging, labelling as well as impact of sales promotion contests;
- Advised pharmaceutical companies on potential conflict of interest, fraud and abuse regulations;
- Provided legal advice to a reputed foreign University in respect of legal requirements for pursuing medical internship programs by the University medical students with a well-known hospital in India.
- Represented and advised a major pharmaceutical manufacturing company on the implication and responses to the various pricing related notices served from the different divisions of NPPA, the impact of the show-cause notice(s) and possible recourses available, making applications for price approval and/or fixation, implication of public notices on pending matters before the NPPA;
- Represented and advised a major pharmaceutical manufacturing company on the pricing issue concerning scheduled and non-scheduled drugs and formulations and the options and the recourses available, the impact of price calculation under order 7 of the DPCO based on the difference in the quality of packaging, the grounds available to the NPPA to fix/revise the price of a non-scheduled formulation;
- Represented and advised a major pharmaceutical manufacturing company on the penal provisions of DPCO and Essential Commodities Act, key issues to keep in consideration while affixing price of a new product to be launched in case a related product is embroiled in pricing controversy, legal obligations of companies who need to follow the strict norms of the NPPA, and liability elements if the pricing norms are not followed;
