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 health-related devices bill by November 30, 2021.
Representations had been made in the previous that there is a want for New Drugs, Cosmetics and Medical Devices as the existing act is totally obsolete dating as back as 1940.
Last year, the union wellness ministry had brought health-related devices inside the regulatory ambit, treating them as a category of ‘drugs’ for the goal 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 contain 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 health-related devices with the notification of New Medical Device (MD) Rules 2017.
New MD Rules 2017 had been notified last year and have come into impact from January 1, 2018 onwards in the nation. Following the notification, troubles connected to post grant compliance, information protection, solution recalls and solution liabilities amongst other people will be implemented properly towards device or solution security.
As of today, 37 health-related device categories have been notified. Earlier, 26 health-related devices had been notified among 2005 and 2017 which has beneath its ambit 364 goods. In December, 2018 3 new devices like nebuliser, glucometer and surgical gowns had been notified.
New MD Rules 2017 covers not only health-related devices but also in vitro diagnostics, disinfectants, surgical sutures, ligature, condoms, bandages, and so on. It sets new requirements for manufacturing and use of health-related devices.