[Answered] How does the new Drugs, Medical Devices, and Cosmetics Bill 2022 ensure that the medical products sold in the country are safe and effective?

The Bill seeks to replace the Drugs and Cosmetics Act of 1940 with an updated law laying down strict regulatory guidelines to keep pace with changing needs and technology. Almost 80% of the medical devices currently sold in the country are imported, particularly high-end devices. The primary objective of this bill is to ensure that the medical products sold in a country are safe, effective and conform to prescribed quality standards.

Provisions for safe and effective selling of medical products:

• Bring in the required expertise: It proposed to establish a statutory Medical Device Technical Advisory Board, with experts from the fields of atomic energy, science and technology, electronics, and related fields like biomedical technology to guide the process.
• Separate Definition of Medical Devices: It includes diagnostic equipment, its software, implants, devices for assistance with disabilities, life support, instruments used for disinfection, and any reagents or kits.
• Medical Devices Testing Centre: The Bill proposes medical device testing centres on the lines of drug laboratories in states and at the central level.
• Clinical Trials: It proposes compulsory permission of the central licensing authority for clinical trials or clinical investigation of drugs and medical devices.
• Medical management and compensation: To persons who are injured while participating in clinical trials. And, in case of death, the legal heir of the participant should be awarded compensation.
• Regulation of e-pharmacies:The Bill specifically states that the Central government must come up with rules to regulate the online sale of drugs and for online pharmacies to operate “in accordance with a licence or permission issued”.
• The draft Bill defines provisions for imprisonment or fines for “adulterated” or “spurious” medical devices.

A modern regulatory system should be designed to guarantee citizens a right to participate in decision-making. There is need to create legal pathways, such as public hearings or citizen’s petitions to enable citizens’ participation in the regulatory process and to register their objections.