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.
The scheme will establish suitable online teaching and learning facilities to facilitate training in health research in various subjects in a more effective manner and for promoting biomedical/health research.
PSA view – The government should come out with more such schemes. Not only will this create employment opportunities, it will also render efficiency to state-run hospitals and other laboratories and research center. The success of the scheme lies in ensuring that it is implemented properly and the personnel are thoroughly trained so that they can perform hospital management in the most efficient manner. There should be a criteria to certify the personnel who have performed well at the training sessions.
Steps Initiated for Self-Certification of Medical Devices
The Association of Indian Medical Devices Industry (“AIMED”) has entered into a memorandum of understanding with the National Accreditation Board of Certifying Bodies and Quality Control of India proposing to introduce a self-certification initiative for the medical device industry. This initiative is launched primarily, to bring in a regulatory reform in the industry and for setting-up definitive guidelines on the standards to be followed by the industry.
As part of this, the AIMED proposes to (i) set-up an independent confirmatory assessment body (“CABs”) accredited by NABCB giving an option to Indian manufacturers to access low cost self certification for their medium and high risk devices; (ii) formulate guidelines for certification of 10 medical devices notified as drugs since 2005; and (iii) appoint trained, certified, competent experts accredited by the CABs for carrying out audit in harmony with the principles of patient safety discussed by the Global Harmonization Task Force on Medical Devices and ensuring compliance of the labeling requirements.
PSA view – This is a pro-active move by AIMED as it enables the manufacturer’s to certify their products at a lower cost. However, the proposed move will be effective only if the standard for self-certification adopted by Indian CAB is at par with the international standard and is recognized by the overseas regulators.
DoP launches Cluster Development Programme for Pharma Sector
The Department of Pharmaceuticals (“Department”) is working at enhancing the infrastructure facilities and innovation capabilities of the small and medium enterprises in the pharma sector and has therefore, proposed to allocate Rs. 125 crore to kick start the project Cluster Development Programme for Pharma Sector (“CDP-PS”). The Department’s focus is to create common facility centres providing facilities such as common testing facilities, training centre, R&D centre and common logistics centre. In this regard, the Department has decided to utilize 90% of the government’s grant towards common facility centres in difficult and backward regions.
The Department proposes to implement the project on a Public Private Partnership format by setting up a Special Project Vehicles for the said purpose. Also, a Project Management Consultant will be engaged to expedite the implementation of the project, to execute setting up of new clusters as well as for up gradation of existing cluster and to assist the department in monitoring the project and allocation of funds to SPVs and their utilization.
PSA view – The Department’s proposal to implement CDP-PS and to reduce the cost of production of clusters by 20% will help not only to improve the competitiveness and productivity of the SMEs in the domestic pharma industry but also increase the availability of medicines in the domestic market. Hence, the Department’s initiative is in the right direction.
Mansi Airi Gambhir