The Ministry of Health and Family Welfare invited comments on the draft Drugs, Medical Devices, and Cosmetics Bill, 2022. 28 Currently, the Drugs and Cosmetics Act regulates the import, manufacture, distribution, and sale of drugs, cosmetics, and medical devices. 29 The draft Bill aims to ensure quality, safety, efficacy, and clinical trial of new drugs and the clinical investigation of investigational medical devices. Key features of the draft Bill include:
1 ▪ Medical devices Advisory Board: The draft Bill seeks to constitute a Medical Devices Technical Advisory Board to advise central and state governments on matters pertaining to medical devices. The Board will consist of ex-officio members, government representatives, nominated members, and experts. The Board will be chaired by the Director General of Health Services.
2 ▪ Clinical trial: Under the draft Bill, prior permission by the central licensing authority (Drugs Controller General) is required to conduct any clinical trial for a new drug. Any person who conducts a clinical trial without obtaining prior permission will be liable for a maximum penalty of five lakh rupees.
3 ▪ Online pharmacies: The draft Bill seeks to regulate online pharmacies. It prohibits any person to sell, stock, or distribute any drug by online mode without a license or permission. It allows the central government to make regulations and restrictions for online sale of drugs.
Comments on the draft Bill are invited till August 22, 2022.
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