Gunjan Verma - India

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Gunjan Verma
Managing Partner
Asia Actual India

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India Establishes Committees to Streamline Regulatory Framework and Address Denovo Products

Published on: October 14th, 2021

The MOH Has Formed a Committee to Address a De Novo Drugs, Cosmetics and Medical Devices Act

The Department of Health and Family Welfare under Ministry of Health has formed a committee to frame a De Novo Drugs, Cosmetics and Medical Devices Act. This comes after representations were made in the past that there is a need for additional guidance/requirements for New Drugs, Cosmetics and Medical Devices as the current act is completely obsolete dating as back as 1940. The centre has constituted a committee for framing/preparing new drugs, cosmetics and medical device laws.

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

The other members of the panel are follows –

1 Dr. VG Somani Drugs Controller General of India (DCGI) Chairperson
2 Shri Rajiv Wadhawan, Director, Union Health Ministry Vice- Chairperson
3 Dr Eswara Reddy, Joint Drug Controller Member
4 Shri AK Pradhan, Joint Drug Controller Member
5 Shri NL Meena Member
6 Drug Controller of Haryana Member
7 Drug Controller of Gujarat Member
8 Drug Controller of Maharashtra Member

DoP Creates an Industry–led Forum for Streamlining of Regulatory Framework For Medical Devices

The Standing Forum of Medical Devices Associations has been constituted which will work on Streamlining the Regulatory framework for medical devices based on the views of the industry. Shri Himanshu Baid, Chairperson of Confederation of Indian Industry (CII) National Medical Technology Forum, will be the Convener of the standing forum. The Standing Forum will submit the report which will have recommendations to Department of Pharmaceuticals by 2nd October 2021.

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