New law to regulate drugs and medical devices soon
Policy

New law to regulate drugs and medical devices soon

The panel is headed by DCGI Dr VG Somani with representatives from various state drug regulators and health ministry

  • By IPP Bureau | September 09, 2021

The medical industry has undergone a rapid transformation over the years and new technologies and platforms have emerged to address the rapidly changing needs of the drug industry. To address these issues and bring transparency and clarity, the government has constituted an eight-member panel for framing a new law for drugs, cosmetics and medical devices.

The proposed new law will replace the existing Drugs and Cosmetics Act 1940. The health ministry has constituted a committee to examine the existing law and release a draft for the new law by November end. The panel is being headed by the Drugs Controller General of India (DCGI) Dr V G Somani. Apart from Somani, the panel will have representation from various other state drug regulators and health ministries.

"The government has decided to constitute a committee for framing/preparation of the New Drugs, Cosmetics and Medical Devices Bill so that the New Drugs, Cosmetics and Medical Devices Act can be framed," a health ministry order issued recently said.

The Drugs and Cosmetics Act, 1940, regulates the import, manufacture, distribution and sale of drugs, cosmetics and medical devices.  The Act has been amended depending on the immediate needs and this is expected to change with the new Act that proposes to address all issues. The last amendment in the Act was made in 2008.

On the terms of reference of the committee, the order said, "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."

A committee under NITI Ayog has earlier suggested a law to only regulate medical devices. 

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