Medical devices need separate regulatory framework

Medical devices need separate regulatory framework

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The vast majority of India’s medical devices of which is nearly 80 per cent import-dependent, are unregulated for quality and safety. While many of these products may have regulatory certifications in other countries, the reality is that a considerable number of them are being exported from countries that do not regulate their exports. The medical devices market in India is over $15 billion (Rs 105,000 crore) and projected to grow to $50 billion by 2025 and is the fourth-largest in Asia.

Thirty years have gone by since the 1st medical device was regulated as a drug in 1989. A comprehensive regulatory framework is nearly in sight with the Draft MEDICAL DEVICES (Safety, Effectiveness & Innovation) Bill from NITI Aayog to be shortly proposed as a Separate Law.

Our policymakers in Health Ministry were surprisingly undecided and seemed to be in no urgency to usher in a ‘Patient Safety Medical Devices Law to protect patients, even after the recent ICIJ implant files or J&J incident, or the most recent ban on Transvaginal Pelvic Mesh by US Food and Drug (FDA). As Ministry of Health & Family Welfare (MoHFW) had been surprisingly very reluctant to draft a separate law preferring to attempt to amend the Drugs Act and Central Drugs Standard Control Organization (CDSCO) has a conflict of interest to empower itself the industry watchers are waiting with anxiety the details of the Draft Medical Devices Bill that NITI Aayog is reportedly working upon in consultation with other stakeholder departments and ministries to address the regulatory vacuum & the national patient safety concerns.