Between 2009 and 2015, India’s medical device industry grew by almost $2billlion.
Presently, only 23 categories of medical devices are regulated under the Drugs and Cosmetics (D&C) Act of India. However, the government does not know exactly how many non-notified medical devices are present in the country and there have also been reports of refurbished devices being imported. Hence, the government has commenced implementation of a common framework of safety and efficacy standards in a phased manner, which all imported and locally-made medical devices will have to meet to enter the Indian market.
Once the appropriate rules and guidance is published, all import, manufacture and sale of medical devices will need to be certified by India’s regulatory authority, the Central Drugs Standard Control Organisation (CDCSO).
According to senior officials,
“All medical devices will have to be registered with the regulatory authority before they enter the market.” “The new rules will take care of all such problems pertaining to medical devices.”
The aim of this initiative by the government is to improve the safety of end-users of these devices. The health ministry is in consultation with a variety of industry experts and associations including the Indian Council of Medical Research and the Bureau of Indian Standards, to map out how these rules will be incorporated into the existing Act.
Currently, there is no system for reporting malfunctioning or non-notified medical devices. One of the key directives is to ensure that every manufacturer or importer of medical devices reports serious adverse events (SAEs) to the CDCSO and materiovigilance programme. The CDCSO will have the authority to suspend registration based on its investigations.
A draft notification regarding the rules is likely to be published soon by the Indian government. To read more, click here.