Health Ministry moots Centre or state bodies be empowered to regulate drugs, cosmetics manufacture

economictimes.indiatimes.com:

Central Drugs Standard Control Organisation (CDSCO) to do so. As of now, all manufacturing activities relating to drugs and cosmetics are regulated by only the state governments through their drug control organisations, official sources told PTI. The draft bill also mentions that the Central government may regulate, restrict or prohibit selling, stocking, exhibiting or offering sale or distribution of any drug online by notification.

The latest draft of the New Drugs, Medical Devices and Cosmetics Bill, 2023, which seeks to replace the Drugs and Cosmetics Act of 1940, is yet to be approved by the Cabinet. It, however, features among the 21 key bills that are on the agenda for the Monsoon session of Parliament. The latest version of the draft bill states, «No person shall himself or by any other person on his behalf manufacture for sale or distribution any drug, except in accordance with a license issued by the Central Licensing Authority or the State Licensing Authority for such drugs, in such form and manner, as may be prescribed.» In the latest draft, it is not clear what type of drug licenses will be regulated by the state and Centre.

«Once the bill is passed in Parliament, the Centre will formulate the rules for regulating drugs, clarifying how much power and what sort of power the states and the Centre would have,» an official source said. The Union Health Ministry has also proposed a separate chapter for regulating cosmetics. Besides, regulations for conducting clinical trials for new drugs and medical devices have been brought under the draft bill.