The Union Health Ministry plans to amend the Drugs and Cosmetics Act, 1940, with an updated version laying down strict regulatory guidelines to keep up with changing needs of the population and the evolving healthcare technologies. A committee has been formed to create comprehensive legislation for framing the drugs, medical devices, and cosmetics bills in 2022. The bill was released on July 8th by the Union Ministry, seeking suggestions from the stakeholders.

The Bill proposed several new definitions for clinical trials, over-the-counter drugs, manufacturers, medical devices, bioavailability studies, investigational new drugs, etc. The new draft seeks to regulate online pharmacies and medical devices. It also includes new clauses for penalization such as imprisonment and compensation in the case of injury or death during clinical trials for drugs. The government has proposed to empower the Drug Control Officer with prior approval to enter any premises related to clinical trials to inspect the facilities, data, documents, etc. The draft allows the center to waive the requirement to conduct clinical investigations for manufacturers or import a new medical device for public use.

Mr. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry, stated that the members of the association are disappointed that the aspirations of a separate act for medical devices have not been addressed and that budding entrepreneurs, start-ups, developers, and engineers will have to grapple with a complex joint law. The bill also includes a chapter on Ayurveda, Siddha, Unani, Sowa-Rigpa, and Homeopathy and their respective Drug Technical Advisory Boards.