The Modi government is set to delink the medical device industry from the pharmaceutical sector, giving a major push for ‘Make in India’ in the medical device sector, according to people privy to the development.

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 currently imports 70 per cent of its medical devices.

The size of the market is estimated at over $10 billion at retail level sales.

Public opinion The Ministry is expected to shortly seek public opinion and comments through the website of CDSCO, the national regulatory body for the domestic pharma and medical devices.

It will then issue a notification for change in the drug rules through the Law Ministry to carry out the delinking.

“Ambiguity in the regulations had for a long time allowed medical inspectors to harass device makers, making it very difficult to run business. Every inspector would interpret the rules with his or her own yardstick and we had no other option but to comply. The new standard would eliminate this and would help the industry to grow,” said Rajiv Nath, an enthused Forum Coordinator for AIMED.

“Make in India of medical devices is now a possibility if the government also makes it viable and profitable to invest, by also simultaneously addressing the adverse inverted duty structure,” he added.

According to experts, the new standard is identical to international standards for medical devices — ISO 13485 — which has already been implemented in Canada, Singapore and European countries. However, device makers with ISO 13485 certification will still require a separate certificate from Indian authorities in order to sell their products here.

Dependence on imports The linking of the medical device sector with pharmaceutical through a common statute and regulatory regime has been a big stumbling block for the medical device sector in the country.

It has contributed to the nation’s humungous import dependence while scaring away investments. India is the only country where the pharmaceutical and medical device sectors are governed by the same set of legislations.

“Regulations in India need to be layered to separate the role of legislature from that of the regulator and that of a supervising accreditation body to assist the regulator.

“The European Commission and USFDA have already gone this way. Such a regulatory framework for medical devices will also create higher international acceptance for Indian products,” said Anil Jauhri, CEO of the National Accreditation Board for Certification Bodies, Quality Council of India.

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