Health ministry to allow separate regulatory framework for medical devices

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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.