NEW DELHI: Expanding the purview of drug regulation, the country's top drug advisory body has suggested notifying all medical devices as 'drugs' and make it mandatory for them to follow regulatory norms such as registration, testing of products as well as reporting of adverse reactions.

At present, merely 23 medical devices are notified as ‘drugs’ and are overseen by the drug regulator. Additionally, the health ministry has notified twelve other products including blood pressure monitoring device, MRI equipment and CT scan equipment as ‘drugs’ in different phases in effect from 2020.

However, many of the medical devices like equipment, analyzers, instruments etc. used in various healthcare facilities for diagnosis, treatment, mitigation are currently out of scope of regulation under Drugs and Cosmetics Act, an official said.

The medical devices market in India is currently pegged at $7 billion and is projected to grow to $50 billion by 2025.

At present, India is the fourth-largest market for medical devices in Asia, after Japan, China and South Korea. However, almost 80% of the medical devices used in the country are imported products.

The proposed move, aimed at ensuring quality, safety and efficacy of widely used medical devices and equipment, is based on recommendations of a committee constituted by the health ministry in February this year, keeping in view the need for comprehensive regulation for all such products and not just a few.

The latest decision was taken in a recent meeting of the Drugs Technical Advisory Board ( DTAB ), headed by director general, Health Services and Drugs Controller General of India as member secretary. Mostly, the decisions recommended by the Board are agreed upon by the health ministry.

“Representations have been received from various stakeholders for regulating all non-notified medical devices since concerns have been raised from time to time in different fora regarding safety, quality and performance of various medical devices including diagnostic kits manufactured/imported in the country,” the official said.

DTAB has also recommended strengthening of manpower and infrastructure in all states to be able to regulate medical devices.

“While we complement drug regulator and health ministry in listening to our requests to bring in a separate regulatory framework for medical devices independent of drugs, but much more needs to be done and in a more planned manner in place of a piecemeal approach. We regret to note certain important strategic directions are missing,” Association of Indian Medical Device industry forum coordinator Rajiv Nath said.

