Health ministry constitutes committee to frame New Drugs, Cosmetics and Medical Devices Bill

New Delhi, September 9, 2021:

The Union ministry of health and family welfare has constituted an eight-member committee for framing a New Drugs, Cosmetics and Medical Devices Bill. The mandate for the Committee is to form a fresh Drugs, Cosmetics and Medical Devices Bill by November 30, 2021.

An order by the Ministry issued towards the end of August, 2021, said that the government has decided to constitute a committee for framing/preparation of New Drugs, Cosmetics and Medical Devices Bill so that New Drugs, Cosmetics and Medical Devices Act can be framed.

The Committee, headed by Chairperson Dr V G Somani, Drugs Controller General (India), will have Director of Drugs Rajiv Wadhawan as Vice-Chairperson and Joint Drug Controllers Dr S Easwara Reddy and A K Pradhan as members. The other members include Drugs Controllers of Haryana, Gujarat and Maharashtra and IAS official N L Meena. The committee may co-opt members if it so requires.

The terms of reference of the Committee, according to the order issued on August 27, is that it “shall undertake pre legislative consultations and examine the present Act, previously framed Drugs and Cosmetics Bills and submit a draft documents for a de-novo Drugs, Cosmetics and Medical Devices Bill by November 30, 2021”.

The Drugs and Cosmetics Act,1990 has been amended over a period of time to include new clauses, in view of the changes happening in the pharmaceutical and medical devices industries over a period of time. The rules, formed in 1945, also underwent several changes over the period, in the wake of the technological changes in the sector.

The DCGI also recently hinted on the government's efforts to reduce the compliance burden and improving the ease of doing business.

It is in this backdrop the government is looking at a new bill, and forming a committee to consider the regulations afresh. At present, the medical devices are also regulated under the rules formed under the Act, and it is expected that the medical devices sector and cosmetics sector will get a refreshed look in the new Bill. PharmaBiz