The Drugs Technical Advisory Board (‘DTAB’), the highest technical advisory body under the Drugs and Cosmetics Act, 1940 (‘DCA’), has approved certain proposals made by an expert committee to further regulate the Medical Devices sector.14 The Committee comprised of experts from the medical industry, regulatory authorities and clinicians who use such devices.15 As a result of the approval, the Medical Devices sector may face more regulations by amendment in the Drugs and Cosmetics Rules, 1945 (‘Draft Regulations’).16
Readers may note that the Ministry of Health and Family Welfare had constituted six medical advisory committees to advise the Central Drugs and Standards Control Organisation (‘CDSCO’) on matters related to review and regulatory approval of new medical devices and clinical trials in India.17 It seems like certain recommendations in form of amendments to the Drugs and Cosmetics Rules, 1945 (‘DCR’) have flowed from the recommendations of these Committees. The proposed amendments cover several aspects of import / manufacture / marketing of medical devices in India such as labeling, shelf life, standards on quality management systems and exemptions for custom made devices for their import.18
Only limited number of Medical Devices are currently regulated under the DCR, where they are classified as drugs. Unfortunately, there are numerous lacunae in the regulation surrounding medical devices sector. To address these lacunae, the Department of Science and Technology had prepared a comprehensive Bill to regulate medical devices sector in India. However, the Bill is pending legislative approval since 2006. Sensing that the Bill may not become an Act soon, the DCGI may have proposed these amendments to the Drugs and Cosmetics Rules, which may not require parliamentary assent.
It seems unlikely that Draft Regulations will be published and enforced immediately. The CDSCO will first prepare a draft and notify it, and publish it for public comment.19