What is the News?
The Union government has constituted a committee for framing legislation regarding new drugs, cosmetics and medical devices.
About the Committee
Headed by: The committee is headed by Drugs Controller General of India V.G. Somani.
Mandate: To undertake pre-legislative consultations and examine the present Drugs and Cosmetics Act,1940, examine previously framed Drugs and Cosmetics Bills and submit a draft document for new Drugs, Cosmetics and Medical Devices Bill.
What is the need for the new law?
Currently, the Drugs and Cosmetics Act,1940 regulates the import, manufacture, distribution and sale of drugs and cosmetics. Through a recent amendment, the law incorporated regulation of medical devices as well.
However, the provisions of this act are limited to govern the rapidly expanding segment which has sophisticated and innovative products entering the market.
Hence, the proposed new law will replace the existing Drugs & Cosmetics Act, 1940. It will comprehensively address areas like medical devices, hospital equipment, e-pharmacy, emergency use authorisation as well as clinical trials etc.
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About the Drugs & Cosmetics Act, 1940
It is the central legislation that regulates India’s drug and cosmetic import, manufacture, distribution and sale. The Act clearly defines spurious drugs, adulterated drugs and misbranded drugs.
This also established the Central Drugs Standard Control Organization (CDSCO). The Act also establishes regulatory control over the manufacture and sale of drugs.
The State Health department has to regulate the manufacturing, sales and distribution of drugs. Drug Inspectors will control the implementation at ground level.
Source: This post is based on the article “Panel set up to draft Bill on drugs, cosmetics and medical devices” published in The Hindu on 8th September 2021.