The Central Government has formed a new committee to frame or prepare new cosmetics, drugs, and medical device laws. The new panel comprising of eight members, headed by the Drug Controller General of India V.G. Somani, has been scheduled to submit a draft document by November 30, 2021.
As per the order issued by the Ministry of Health and Family Welfare, “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 can be framed.”
The Drugs and Cosmetics Act, 1940, regulates the import, distribution, manufacture, and sale of drugs, medical devices, and cosmetics. The act has been amended from time to time and the last amendment was made in 2008.
What will be the work of the new committee?
The order by the Health and Family Welfare Ministry stated that the committee will undertake the pre-legislative consultations and will examine the present Act, previously framed Drugs and Cosmetics Bills, and submit draft documents for a de-novo Drugs, Cosmetics and Medical Devices Bill by November 30, 2021.
Need of different rules for medical devices
Currently, there is no distinction between the regulatory treatment of drugs and medical devices. The import, manufacture, distribution, and sale of drugs, medical devices, and cosmetics are regulated under the D&C Act of 1940.
Both medical devices and drugs are now regulated by CDSCO under the Ministry of Health.
According to Rajiv Nath, the Association of Indian Medical Device Industry said that the separate rules were a good decision to permit the device industry to have its own home but CDSCO is not letting go. He further added that if food can have FSSAI, we also need something for devices.
NITI Aayog Bill to regulate devices separately:
The NITI Aayog had earlier proposed legislation in 2019 for medical devices and an independent regulator for the industry.
Under the proposed framework, the patients who have been suffering due to faulty medical devices will be able to claim compensation from the manufacturer or the importer of the device. Currently, there are no legal provisions for those who have been suffering from this problem.
Source: Jagran Josh