Indian government proposes bill to regulate new drugs, clinical trials

As part of its efforts to keep up with changing technologies and to eliminate obsolete laws and regulations, the Indian government has unveiled a draft of the New Drugs, Medical Devices, and Cosmetics Bill 2022.

This will replace the existing Drugs and Cosmetics Act of 1947, with the public and stakeholders asked to provide suggestions, comments, and objections within 45 days.

The new draft bill seeks to, among others, propose new definitions for clinical trials, over-the-counter drugs, new drugs, bioavailability study, investigational new drug and imported spurious drugs, as well as provide for penalties including imprisonment for failure to provide compensation for injury or death arising from clinical trials.

In the draft, the Central Licensing Authority of India may, in the public interest, abbreviate, defer or waive pre-clinical and clinical data requirements for approval of new drugs for life-threatening or serious diseases and rare diseases.

In addition to regulating e-pharmacies and medical devices, the Indian government is also considering criminal penalties, including imprisonment, for clinical trials. This is the first time such a measure has been considered by the government.

Clinical trials must also be approved by the apex drug regulator according to the draft bill, though this requirement was not included in the previous law.

Provisions for individuals injured during trials

The draft bill states that individuals injured during clinical trials should receive medical treatment and compensation, while the legal heir of the participant should receive compensation in the event of the participant's death.

"In light of recommendations of the central government and the need to have comprehensive legislation, a committee was constituted for framing the New Drugs, Cosmetics and Medical Devices Bill," the ministry said.

The government will constitute a Drugs, Medical Devices, and Cosmetics Consultative Committee to advise federal, state, and medical device technical advisory boards regarding the secure implementation of the project.