Regulation of medical devices: Draft Bill suggests separate expert group, check on online pharmacies

Source: The post is based on the article “Regulation of medical devices: Draft Bill suggests separate expert group, check on online pharmacies” published in Indian Express on 10th July 2022

What is the News?

The Union Health Ministry has released the new draft ‘Drug, Medical Devices, and Cosmetics Bill-2022’.

What is the Draft ‘Drug, Medical Devices, and Cosmetics Bill-2022’?

Purpose: 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.

Salient Provisions

Separate Definition of Medical Devices: The Bill has a separate definition for medical devices that bring under its ambit diagnostic equipment, its software, implants, devices for assistance with disabilities, life support, instruments used for disinfection, and any reagents or kits. The previous 1940 Act regulated medical devices as one of the four categories of “drugs”.

Medical Technical advisory board: The Bill proposes a medical technical advisory board along 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.

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: The Bill proposes compulsory permission of the central licensing authority for clinical trials or clinical investigation of drugs and medical devices. Although companies at present also have to seek permission from the apex drug regulator to conduct trials, it was never mentioned in the previous law.

– The Bill also says that medical management and compensation have to be provided 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”.