The government has built 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.
As per the health ministry, the committee shall
undertake pre-legislative consultations and examine the present Act, beforehand framed drugs and cosmetics bills and submit a draft document for a de-novo drugs, cosmetics and medical devices bill by November 30, 2021.
Currently, 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.
Following the faulty hip implant case involving J&J, the Niti Aayog had earlier proposed legislation for medical devices and an independent regulator for the industry in 2019. Under the proposed regulatory framework, patients suffering because of faulty medical devices and implants would be able to demand compensation from the manufacturer or the importer of the device.
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