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An industry body for medical device manufacturers is opposing the Centre’s plan to bring the New Drugs, Medical Devices and Cosmetics Bill, 2022 to Parliament in the upcoming monsoon session, and has written to Health Minister, expressing its dismay. The move to introduce and pass the legislation, which aims to regulate drugs and medical devices, has been done without holding even a single meeting with major stakeholders, the Association of Indian Medical Device Industry said. They added that it was strange that the Parliamentary Committee’s 138th report, which recommends a separate law for medical devices, had not been taken into consideration.
New Drugs, Medical Devices and Cosmetics Bill, 2022
The New Drugs, Medical Devices and Cosmetics Bill, 2022 is a proposed law in India that would replace the existing Drugs and Cosmetics Act, 1940. The bill was drafted by the Ministry of Health and Family Welfare and was released for public consultation in July 2022.
The bill aims to modernize the regulatory framework for drugs, medical devices and cosmetics in India. It would introduce a number of new provisions, including:
- Establishment of a new regulatory authority, the Drugs, Medical Devices and Cosmetics Authority (DMDC). The DMDC would be responsible for regulating all aspects of the drugs, medical devices and cosmetics sector, including licensing, testing, marketing and advertising.
- Strengthened provisions for clinical trials. The bill would require all clinical trials to be conducted in accordance with international standards and would provide for compensation for participants who are injured or die as a result of a clinical trial.
- Increased focus on the safety and efficacy of drugs and medical devices. The bill would require all drugs and medical devices to be evaluated for safety and efficacy before they can be marketed in India.
New provisions for the regulation of cosmetics. The bill would introduce new provisions for the regulation of cosmetics, including requirements for safety and labeling.
