Drugs, Medical Devices and Cosmetics Bill released for comment

NEW DELHI : The Department of Health plans to replace the Medicines and Cosmetics Act of 1940 with an updated law establishing strict regulatory guidelines to keep pace with changing needs and technology.

Considering the need for comprehensive legislation, a committee has been formed to oversee the Medicines, Medical Devices and Cosmetics Bill, 2022, which was published on July 8 for stakeholders to share. of their suggestions.

The bill proposes new definitions for clinical trials, over-the-counter drugs, manufacturers, medical devices, new drugs, bioavailability studies, investigational new drugs, and fake imported drugs, among others.

It aims to introduce regulation for online pharmacies and medical devices and penalties such as imprisonment and compensation for injury or death in clinical drug trials.

“In light of the central government’s recommendation and the felt need for comprehensive legislation, a committee has been formed to oversee the Drugs, Medical Devices and Cosmetics Bill. Work to review and update the Drugs and Cosmetic Rules 1945 resumed from 2016,” the government said in a document viewed by Mint. No clinical trial can be carried out without authorization, medical care and compensation in the event of injury or death, according to the draft “No one shall sell, store, exhibit, offer for sale or distribute a medicine by the online mode (e-pharmacy) itself or by another person on its behalf, except under and pursuant to any license or authorization issued in such manner as may be prescribed,” the draft states.

The government has proposed empowering the Medicines Control Officer, with prior approval from the control authority, to enter all premises related to clinical trials to inspect facilities, records, data, documents , books and medicines.

The Center has proposed a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB) to make suggestions to the government from time to time.

The draft proposes to authorize the Center to waive the obligation to conduct a clinical investigation for the manufacture or import of a new medical device of public interest.

“We are studying the project and soliciting comments from our members. We are disappointed that the aspirations of a separate law for medical devices have not been taken into account and aspiring entrepreneurs and startups, developers and engineers will still have to grapple with a complex common law. Medical devices have huge investment potential of more than 50,000 crore to meet the market of more than 1 trillion. Once we study the fine print, we will be in a better position to comment on the efforts of the Ministry of Health in drafting this bill,” said Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry. The bill includes a chapter on Ayurveda. , Siddha, Sowa-Rigpa, Unani and Homeopathy, and their respective Technical Medicine Advisory Councils.

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