The efforts of government think tank Niti Aayog to improve transparency and quality within the medical sector includes a Rs 1 crore fine for firms who import or manufacture unsafe medical devices. Per draft legislation, the Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019, a National Register of Medical Devices would be devised wherein each […]
Niti Aayog
FDA India: A single regulator on the cards?
A single regulator for food, medical devices, and medicines is on the cards in India, as the government think tank Niti Aayog has proposed a body analogous to the Food and Drugs Administration (FDA) in the United States. At present, food safety is overseen by the Food Safety and Standards Authority of India (FSSAI) and […]
Opposition to Central medical device regulation
Government think tank Niti Aayog has voiced opposition to the Health Ministry’s proposal to bring the regulation of medical devices under the authority of the Central Drugs Standard Control Organisation (CDSCO), effectively bringing the manufacture and sale of all medical devices into the purview of the Centre. The Union Health Ministry has put into place […]