The recently-released draft of the New Drugs, Medical Devices and Cosmetics Bill, 2022, by the Union Ministry of Health and Family Welfare has proposed to regulate e-pharmacies, clinical trials and medical devices among others.
The Bill has been drafted to keep pace with changing needs, times, and technology as the existing Drugs and Cosmetics Act, 1940, is a pre-independence legislation, according to the Health Ministry.
Obsolete law
Last year, the Central Government had constituted a committee to review obsolete laws and frame the Bill. The Ministry has invited suggestions, comments and objections from the public and stakeholders with regard to the draft Bill, within a period of 45 days from July 8, the date of issue of notice.
The draft includes provisions for penalties, including imprisonment, for failing to pay compensation for injury or death during clinical trials for both drugs and medical devices.
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 committees are regulated under the New Drugs and Clinical Trials Rules, 2019.
Online pharmacies
Suggesting that the Central government should formulate rules for regulating online pharmacies, the draft Bill prohibits any person from selling, keeping stock, exhibiting or offering for sale or distributing any drug by online mode, except under and in accordance with a licence or permission issued by the authority.
Apart from regulation of clinical trials, the Bill proposes new definitions for over-the-counter drugs, manufacturers, new drugs, bioavailability study, investigational new drug and imported spurious drugs, among others.
Medical devices
The draft Bill makes provision for creation of a ‘medical devices technical advisory board’ on the lines of the existing drugs technical advisory board. This board will not only include medical professionals, but also people with technical knowledge of the devices. Other than officials from the Health Ministry, the board will also include people from the department of atomic energy, department of science and technology, ministry of Electronics, DRDO, and experts in the field of biomedical technology, biomaterials, and polymer technology. Currently, decisions regarding medical devices are taken by the drugs technical advisory board.
The draft also proposes to allow the Centre to waive the requirement of conducting clinical investigation for manufacture or import of a new medical device in public interest. It also includes a chapter on Ayurveda, Siddha, Sowa-Rigpa, Unani and Homeopathy, and their respective Drug Technical Advisory Boards.
