Health ministry to allow separate regulatory framework for medical devices

The health ministry is likely to separate the regulatory approval process for medical devices from the pharma sector.  The ministry is expected to issue a draft notification proposing changes in the Drugs and Cosmetic Rules soon, as recently confirmed by Business Today.

As reported by the Medical Dialogues team on the issue earlier, AdvaMed, an association of medical device manufacturers has stated that a separate act to regulate medical devices in India will be tabled in the parliament soon.

This move has been long pending as the government controls only 22 listed devices out of the total of 14,000 medical devices currently owned by India.

The amendments by the health ministry will only free the devices industry to function under a separate regulatory framework. It will continue to be under the regulatory purview of the Drugs Controller General of India. 

Also read: Government aims to boost medical devices manufacturing to a $50 billion industry

This initiative will secure the interests of the patients by providing them quality products available in the market. AdvaMed caters to 40% of the total medical devices in India. As of the now, the industry is only focused on resolving issues of access, affordability and reach of such medical devices. With this development, safe and good quality products can be sourced from India as well.

"Indian medical devices have for long been incorrectly and incompletely regulated. This has been confusing overseas and Indian investors. Medical device is an engineering industry", says

Rajiv Nath, cordinator of the Association of Indian Medical Devices Industry (AIMED), as reported by Business Today.

The decision to create separate rules for device makers, in line with global standards, was taken after a meeting of senior officials of the Ministry of Health & Family Welfare and the Central Drugs Standard Control Organisation (CDSCO) with industry representatives including the Association of Indian Medical Device Industry (AIMED), people attending the meeting told BusinessLine.

India imports 70 per cent of its medical device requirements from a total global market sieze of $10-billion. An internationally reputed regulatory framework  will only help India sustain a viable position in medical devices manufacturing.