Govt to table new drugs, medical device bill in monsoon session
New Delhi: The Centre will likely table the New Drugs, Medical Devices and Cosmetics Bill, 2023, in the Parliament in the monsoon session that starts Thursday. There are 21 new bills and seven old bills listed for discussion during the session which will last till 11 August.
The New Drugs, Medical Devices and Cosmetics Bill, 2023, will replace the existing 80-year-old Drugs and Cosmetic Act of 1940 with updated laws and strict regulatory norms for the pharmaceutical sector. “The bill seeks to regulate the import, manufacture, distribution and sale of drugs, medical devices and cosmetics; and ensure their quality, safety, efficacy, performance and clinical trial of new drugs and clinical investigation of investigational medical devices and clinical performance evaluation of new in vitro diagnostic medical device including AUSSH drugs, medical devices and cosmetics with the objective of highest possible regulatory standards and a transparent regulatory regime and to repeal the Drugs and Cosmetics Act, 1940," as per a government document reviewed by Mint.
The bill proposes new definitions for clinical trials, over-the-counter drugs, manufacturers, medical devices, new drugs, bioavailability study, investigational new drug and imported spurious drugs, medical device and aims to regulate online pharmacy stores. To regulate e-pharmacy, the draft bill says, “No person shall himself or by any other person on his behalf sell, or stock or exhibit or offer for sale, or distribute, any drug by online mode (e-pharmacy) except under and in accordance with a license or permission issued in such manner as may be prescribed." The Centre has also proposed a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical
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