Centre forms committee for framing new law for medicines, cosmetics, medical devices

The Union Health Ministry has formed a committee to frame the New Drugs, Cosmetics and Medical Devices Bill for the enactment of New Drugs, Cosmetics and Medical Devices Act.

As per the terms of reference of the order titled ‘Constitution of Committee for Framing of New Drugs, Cosmetics and Medical Devices Act’, the committee shall undertake pre-legislative consultations and examine the present Act, previously framed drugs and cosmetics bills and submit a draft document for a de-novo drugs, cosmetics and medical devices bill by November 30, 2021.

Representations were made in the past that there is a need for New Drugs, Cosmetics and Medical Devices as the current act is completely obsolete dating as back as 1940.

Last year, the union health ministry had brought medical devices within the regulatory ambit, treating them as a category of ‘drugs’ for the purpose of regulation.

The newly formed eight-member panel is headed by the Drugs Controller General of India (DCGI) VG Somani.

The other members of the panel include Rajiv Wadhawan, Director, Union Health Ministry, Dr Eswara Reddy, Joint Drug Controller, AK Pradhan, Joint Drug Controller, NL Meena and Drug Controllers of Haryana, Gujarat and Maharashtra.

The Drugs and Cosmetics (D&C) Act, 1940 regulates the import, manufacture, distribution and sale of drugs and cosmetics. Recently, it was amended to add medical devices with the notification of New Medical Device (MD) Rules 2017.

New MD Rules 2017 were notified last year and have come into effect from January 1, 2018 onwards in the country. Following the notification, issues related to post grant compliance, data protection, product recalls and product liabilities among others will be implemented effectively towards device or product safety.

As of today, 37 medical device categories have been notified. Earlier, 26 medical devices were notified between 2005 and 2017 which has under its ambit 364 products. In December, 2018 three new devices like nebuliser, glucometer and surgical gowns were notified.

New MD Rules 2017 covers not only medical devices but also in vitro diagnostics, disinfectants, surgical sutures, ligature, condoms, bandages, etc. It sets new standards for manufacturing and use of medical devices.