Industry, patient groups want draft drugs and medical devices Bill recalled

Seek a separate 'Medical Devices Act' distinct from the drug regulations Bill

Medical device makers, patient interest groups and hospitals are among those who have written to Union Health Minister Mansukh Mandaviya to recall the draft New Drugs, Medical Devices and Cosmetics Bill, 2023, which is expected to be tabled in the monsoon session of Parliament. Instead, they want a separate Bill for medical devices distinct from drugs.

The lobby groups pleaded that if the Bill is passed, the medical devices manufacturing sector would be pushed into a “supply chain crisis” and would “effectively lose its ability to meet domestic demand”.

The letter to the minister, dated August 2, was signed by the Association of Indian Medical Device Industry, the umbrella body for domestic medical devices makers; Association of Diagnostics Manufacturers of India; association for in-vitro diagnostics industry; Association of Healthcare Providers (India), which represents small and medium hospitals; Surgical Dressing Manufacturers Association; Preventive Wear Manufacturers Association of India; Surgical Instrument Development Society; All India Syringe and Needle Manufacturers Association; Orthopaedic Rehabilitation Aid Manufacturers Association; and Patient Safety and Access Initiative of India Foundation.

 

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These lobby groups have requested for a consultation meeting with a fresh committee under the chairmanship of the Indian Council of Medical Research, Department of Science and Technology, Department of Biotechnology and key stakeholders before the draft Bill is finalised and tabled.

The associations have reiterated their long-standing demand for a separate “Medical Devices Act”, different from the one meant for drug regulations. The medical devices industry has been asking for a separate statutory body, such as the Food Safety and Standards Association of India (FSSAI), for regulating medical devices.

FSSAI is an autonomous body under the health and family welfare ministry. “Food is different from drugs and thus, the FSSAI was created to monitor it. Similarly, the NITI Aayog is of the opinion that a separate body needs to be created for medical devices, too,” an industry source told Business Standard.

In their letter, the associations noted: “Legislations adopted in other progressive countries like Canada, EU, UK, Japan, Brazil, Saudi Arabia etc and the visionary NITI Aayog Draft Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 could act as impactful works of reference.”

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In December 2019, NITI Aayog had proposed to bring all medical devices under one regulatory regime in a phased manner and have a separate Medical Devices Administration with four divisions.

NITI Aayog had proposed to do away with the need for a manufacturing licence to register a medical device or get a certificate of compliance. The government had also mooted a National Register of Medical Devices wherein all devices with a unique identification number, manufacturers, importers, distributors and foreign manufacturers would be included in one database.