Government takes steps to delink medical devices from pharmaceutical regulations

At present medical devices are being regulated as drugs by CDSCO and State Drug Controllers


India is import dependent for 70 percent of its medical devices

Responding to the long standing demand of medical device industry to delink it from pharmaceutical sector, the government has taken initial but firm steps towards this finality. The intention to achieve this objective has been spelled out after a meeting of senior officials of MoH and FW, Govt of India and CDSCO with Industry Representatives including AIMED.

The ministry will shortly be soliciting public opinion/comments through CDSCO website and issue a notification for change in Drug Rules through the Law Ministry for enabling this de-linkage.

It may be noted that the irrational traditional linking of medical device sector with pharmaceutical through common statute and regulatory regime has been a big stumbling block in unlocking the full potential of this critical sector and had contributed to India's humungous import dependency, while scaring away investment. Nowhere in the world are pharmaceutical and medical device sector governed by the same set of legislations as has been historically happening in India.

"Indian Medical Devices have for long been incorrectly and incompletely regulated. This has been confusing overseas and Indian investors who were scared to invest with a pharmaceutical type GMP demands being imposed by regulators in an arbitrary and prescriptive manner by unsure inspectors on an engineering industry. The government has taken the first correct strategic steps in the appropriate direction to address the ambiguity" said Mr Rajiv Nath, forum coordinator for AIMED. "Make in India of medical devices is now a possibility if Government also makes it viable and profitable to invest by also simultaneously addressing the adverse inverted duty structure."

Mr Nath has pointed out that the next steps to realize the dream of robust domestic medical device industry which is aligned to PM Modi's vision of ‘Make in India', it is hoped that country will soon adopt a risk proportionate regulatory framework whereby medical devices of low Patient Safety risk like wheel chairs have a lower regulatory requirement and moderately risky devices like Needles have a higher regulatory requirements and high risk devices like orthopedic implants and cardiac stents have even higher regulatory compliance requirements.

This should be followed by unbundling of regulations and regulatory controls whereby the regulators need to delegate the task of compliance audit of manufacturers to Third Party Competent and Accredited Conformity Assessment and Certification Bodies.


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