Govt moots regulations of e-pharmacies, trial mishap penalties in new bill

new delhi: The government has proposed a new bill which for the first time seeks to regulate e-pharmacies and medical devices and provides for penalties including imprisonment for failing to pay compensation for injury or death during clinical trials for both drugs and medical devices.

Also, for the first time, regulations for conduct of clinical trials for new drugs and medical devices have been brought under the draft New Drugs, Medical Devices and Cosmetics Bill, 2022 which seeks to replace the existing Drugs and Cosmetics Act of 1940.

Currently, conduct of clinical trials for new drugs and medical devices and the provisions for compensation for injury or death on account of participation in clinical trials, medical management of the trial participants and regulation of ethics committee etc are regulated under the New Drugs and Clinical Trials Rules, 2019. Also, medical devices are treated as drugs and there is no separate definition of them.

The draft bill has a separate chapter for AYUSH drugs which proposes to regulate Sowa Rigpa and Homeopathy for the first time. The existing act regulates Ayurveda, Unani and Siddha drugs and cosmetics. The draft bill has been put up in the Union health ministry's website and suggestions, comments and objections from the public and stakeholders have been sought within 45 days from the date of issue of the notice (July 8). The work of review and updating of Drugs and Cosmetics Rules, 1945 was vigorously taken up from 2016.

"In light of recommendations of the central government and the felt need to have comprehensive legislation, a committee was constituted for framing the New Drugs, Cosmetics and Medical Devices Bill. "As per recommendations of the committee, the Ministry of Health a proposes a draft New Drugs, Medical Devices and Cosmetics Bill, 2022 in order to keep pace with changing needs, times, and technology," the ministry said.

The draft bill introduces various new definitions or provisions like bioequivalence study, bioavailability study, clinical trial, clinical investigation, controlling authority, manufacturer, medical device, new drugs, over the-counter (OTC) drugs, adulterated cosmetics, etc. for more clarity and smooth functioning and implementation, an official said.

It proposes for the constitution of a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB), comprising experts from various associations to advise the central government in technical matters. The penalties for offences related to import of drugs and cosmetics have been enhanced appropriately, the official said.

The proposed bill provides for regulation of clinical trial of new drugs, investigational new drugs, ethics committee, etc.

"However, in the interest of public health or extreme urgency of drugs, the central government is empowered to make provisions for Central Licensing Authority to waive the requirement of conducting clinical trial for manufacture or import of a new drugs or investigational new drugs in the country," the draft read.

Currently all these provisions are there in the Rules but now it has been proposed in the bill, the official said.