To ensure all medical devices in the Indian market follow safety and quality standards, the Union health ministry on Tuesday, through a notification, stated that all equipment intended for treating humans and animals will be regulated as a “drug” under the Drugs and Cosmetics Act April 1 onwards.
Currently, only 23 categories of medical devices are regulated under the Act. “The notification gives a wide definition of the term medical devices. So far, 23 categories of devices were being regulated under the act and these were being added as piecemeal; this notification will bring all devices under the ambit of the law,” said Malini Aisola, co-convenor of All India Drug and Action Network.
The health ministry has, in another Gazette notification amended the Medical Device Rules, 2017, which will bring the devices under regulation in a phased manner. It states that for eighteen months after the rules kick in on April 1, device manufacturers and importers can voluntarily register with the country’s apex drug regulator the Central Drugs Standard Control Organisation.
Thereafter, it will be made mandatory – the low to moderate risk category A and B devices from 30 months after the notification and moderate to high risk category C and D devices 42 months onwards. “This means most of the devices will not be regulated for up to 2.5 to 3.5 years after the notification. This is a long wait for regulating high risk devices,” said Aisola.
While the industry wants the regulations, they feel some of their concerns have not been addressed. “Some issues that we had raised with the health ministry have not been addressed.
The Act has risk proportionate control – meaning more regulatory control for higher risk drugs – there is no proportionate penalty. Drug controllers can initiate criminal action for a malfunctioning intraocular lens the same as spectacles. Also, devices are engineering products and must be regulated by scientists and engineers and not pharmacists,” said Rajiv Nath, forum coordinator, AiMED.
