India is the 4th largest market for medical devices in Asia. According to the national investment promotion and facilitation agency, Invest India, orthopaedic prosthetics and patient aids segments are expected to grow at a CAGR of 9.6% and 8.8%, respectively whereas diagnostic imaging, dental products, and consumables are expected to grow at a CAGR of 7.1%, 7.4% and 7.1%, respectively during 2015-20.
Minister of Chemicals and Fertilisers D V Sadananda Gowda recently informed that the Indian medical devices sector can reach $50 billion by 2025. “Indian pharmaceuticals and medical devices sector has the potential to become the world leader and government will provide all necessary support,” he added.
However, more than 80% of the country’s requirement of medical devices is met through imports. Though the new government under the aegis of Narendra Modi is pushing for its “Make in India” agenda to promote domestic manufacturing, the initiative is yet to yield tangible results at least in the field of medical devices manufacturing. Thus, to ensure requisite quality of the medical devices imported, produced and sold in India, a stricter law was need of the hour. Accordingly, the Union health ministry issued a notification announcing all medical equipment used on humans or animals has been notified as “drugs”. This move is primarily aimed at bringing all medical devices including disposable syringes, needles, cardiac stents, catheters, heart valves, X-ray and ultrasound machines, under the ambit of regulation in a phased manner and will come into effect from April 1.
The Medical Device Rules, 2020 is an amendment to the Medical Device Rules, 2017 requiring the registration of all non-Notified medical devices over an 18-month period with the Central Drugs Standard Control Organization (CDSCO). In a nutshell, once notified, the manufacture, import and sale of all medical devices will need to be certified by the CDSCO. Experts believe that such regulation will ensure quality and safety for patients.
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