Govt committee for drugs & medical devices

Indian government has establish an expert committee which will focus on framing new laws for medicines, cosmetics and medical devices with the purpose to replace the Drugs and Cosmetics Act’ 1940. The committee is formed by Ministry of Health and Family Welfare. The eight member committee will submit its first draft by November 30.

As per health ministry, he committee shall undertake pre-legislative consultations and examine the present Act, and previously framed drugs and cosmetics bills. Currently, there is no distinction between the medical device and regulatory treatment of drugs.

Following the faulty hip implant case which involved J&J, in 2019 Niti Aayog had proposed legislation for medical devices and an independent regulator for the industry. Under the proposed framework, the patients which are suffering due to faulty medical devices and implants would be able to claim for compensation from manufacturer or the importer of the medical device.

Rajiv Nath, forum coordinator, Association of Indian Manufacturers of Medical Devices (AiMeD) commented, “The Niti Aayog 2019 draft Bill to regulate devices was in the right direction.” He further added that the new order of the government will confuse potential investors.