The central government is planning regulatory checks on quality of all medical devices — including diagnostic equipment such as MRI scanners — that are marketed in the country.
All medical device manufacturers and importers will have to register with the country’s drug regulatory authority, the Drugs Controller General of India (DCGI), though the regulatory requirements will be based on life-saving and critical nature of the devices.
While companies that manufacture or supply external devices will be asked to self-regulate the quality of products, implantable devices such as cardiac stents will be directly regulated by DCGI.
A comprehensive amendment to the current drug law, to bring all medical devices under the regulatory purview of the health ministry, was underway, Dinesh Trivedi, minister of state for health and family welfare, said.
The current size of the domestic medical device, diagnostics and equipment industry was only 6 per cent of $35-billion healthcare sector (which comes to $2.1 billion, or Rs 9,450 crore), the minister added.
Addressing a national workshop on medical devices organised by the Federation of Indian Chambers of Commerce and Industry here, Trivedi said the Central Drug Authority Bill had been sent to states for comments and would be finalised soon. “We will give the states a deadline to respond and take the bill forward,” the minister said. There are only 14 medical devices that are currently being categorised as drugs and are being regulated under the existing drug laws.
