The Ministry of Health and Family Welfare has recently set up an expert committee to frame new laws for medicines, cosmetics and medical devices in a bid to replace the existing Drugs and Cosmetics Act which was formed in 1940. An eight-member committee headed by the drug regulator has been formed by the ministry of health and family welfare. The committee will have to submit the draft by November 30.
At present, there is no distinction between the regulatory treatment of drugs and medical devices. The Drugs and Cosmetics (D&C) Act, 1940 regulates the import, manufacture, distribution and sale of drugs and cosmetics. Both drugs and medical devices are now regulated by the Central Drugs Standard Control Organisation (CDSCO) under the health ministry.
According to the health ministry, 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.
Prior to this move, the health ministry had issued a notification to regulate all medical devices. Last year, the ministry had brought medical devices within the regulatory ambit, treating them as a category of drugs to regulate them. As of today, 37 medical device categories have been notified and regulated under the Medical Devices Act 2017.