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

The Union Health Ministry has mooted that either the Centre or state authorities be empowered to regulate the production of drugs and cosmetics, changing its earlier proposal of allowing only the 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.

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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.

It also provides for regulation of clinical trials of new drugs and investigational new drugs.

"Notwithstanding, anything contained in this Act, the Central Licensing Authority or the Central Drugs, Medical Devices and Cosmetics Regulatory Authority may in public interest, abbreviate, defer or waive such pre-clinical and clinical data requirements for approval of new drug or clinical trials of new drug, investigational new drug or approval of medical device or clinical investigation of investigational medical device... taking into account its severity, rarity, un-met medical need, emergency, extreme urgency," the draft Bill read.

Currently, clinical trials for new drugs and medical devices as well as the provisions for compensation for injury or death on account of participation in such trials are governed by the New Drugs and Clinical Trials Rules, 2019.

Also, medical devices are treated as drugs and there is no separate definition for those.

The draft New Drugs, Medical Devices and Cosmetics Bill, 2023, has a separate chapter on AYUSH medicines, proposing for the first time to regulate Sowa Rigpa and homoeopathy.

The existing Act regulates only Ayurveda, Unani and Siddha drugs and cosmetics.

The draft Bill has introduced various definitions or provisions, such as bioequivalence study, bioavailability study, clinical trial, clinical investigation, controlling authority, manufacturer, medical device, new drugs, over-the-counter drugs, and adulterated cosmetics, for more clarity and smooth implementation, an official said.

The penalties for offences related to the import of drugs and cosmetics have been enhanced appropriately in the draft Bill, another official said.

The draft New Drugs, Medical Devices and Cosmetics Bill was placed in the public domain last year, seeking feedback from stakeholders.

The Union Health Ministry and the CDSCO received several comments from the stakeholders on the draft Bill, which was revised accordingly by the ministry and sent for inter-ministerial consultations in April. It has been revised again.