BS RAWAT
New Delhi: The government has brought all medical devices, including implants and contraceptives, under the lens of the Central Drugs and Standard Control Organisation (CDSCO) so as to improve their safety and quality, Union Minister of State for Health Ashwini Kumar Choubey has informed the Rajya Sabha.

Responding to a question, Mr Choubey said that no proposal has been approved regarding establishment of a separate statutory body on the lines of the Food Safety and Standards Authority of India (FSSAI) for the regulation of medical devices.

In order to bring all the non-notified medical devices under regulation, the Health ministry has prepared a roadmap and published draft rules dated October 18.

Further, a notice has been issued seeking comments of all stakeholders on a proposal to notify all the medical devices under sub section (b) of section (3) of the Drugs and Cosmetics Act, 1940 to regulate them as per the provisions of the said Act and Medical Devices Rules, 2017 framed thereunder, Choubey said.

The draft legislation, titled Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019, proposes a separate regulator under the Directorate General of Health Services to monitor the Indian medical devices sector.