Govt to replace Drugs and Cosmetics Act 1940, forms panel to frame new laws

The eight-member panel will review the 1940 Drugs and Cosmetics Act and suggest new legislation to regulate drugs, cosmetics, and medical devices in the country. As per various media reports, the committee is expected to submit a draft document by November 30.

While Dr Somani will chair the committee, Rajiv Wadhawan (Ministry of Health and Family Welfare Director), Dr Eswara Reddy (Joint Drug Controller), AK Pradhan (Joint Drug Controller), IAS officer NL Meena, and heads of drug control authorities from Haryana, Gujarat, and Maharashtra are among the other members, reports UNI.

The order in this regard read, "The government has decided to constitute a committee for the framing /preparation of New Drugs, Cosmetics and Medical Devices Bill so that New Drugs, Cosmetics and Medical Devices Act can be framed."

The order issued by the Health Ministry for the framing of the New Drugs, Cosmetics, and Medical Devices Bill titled as "Constitution of Committee for Framing of New Drugs, Cosmetics and Medical Devices Act" further added, "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."

According to the National Regulatory Authority (NRA) of India's Central Drugs Standard Control Organisation (CDSCO), the Drugs and Cosmetics Act, 1940 regulates the import, manufacture, distribution, and sale of drugs and cosmetics.

However, last year, the union health ministry included medical devices in its regulatory framework, categorising them as "drugs" in order to regulate. The Medical Dialogues Team had reported earlier that in pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, had specified all medical devices intended for use in human beings or animals as drugs.

Now, the central government has set up an eight-member expert committee to develop new legislation for drugs, cosmetics, and medical devices.

According to a recent media report in News18, pharmaceutical industry experts responded to the aforementioned decision by saying that the previous Act, which was passed in 1940, is now completely outdated. Since 1940, it has been amended multiple times. It has suddenly become highly confusing and unclear for the industry.

Commenting on the frame of the committee, Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry, told News18, "This is a huge conflict of interest to create such a committee without representation from other stakeholders like manufacturers, doctors, academia, scientists and consumer or patient bodies,"