Health Ministry Brings 8 New Medical Devices Under Regulatory Regime

NEW DELHI, 9 FEB 2019: Bringing in more high-end medical equipments such as implants, X-ray machines, MRI and CT scan equipment, and dialysis machines under the purview of drug law, the health ministry on Friday notified eight new devices as ‘drugs’ with effect from April 1, 2020.

The move is aimed at regulating quality of these commonly used devices which are critical to healthcare.

At present, only 23 medical devices – notified as ‘drugs’- are regulated under the Drugs and Cosmetics Act. For all others, there is no mechanism or wherewithal with the government to regulate quality or efficacy.

The list also includes defibrillators, PET equipment, and bone marrow cell separator.

In a separate meeting of a committee constituted by the health ministry for preparation of a road map for the regulations of medical devices, it was decided to bring all such devices under the regulatory scanner by making it mandatory for manufacturers and importers to register all such products in the country and carry the details on their labels, making them traceable. Besides, such companies will also have to report serious adverse events caused from their products.

These decisions were taken on Friday in the first meeting of the committee, headed by the Drugs Controller General of India (DCGI). The meeting was also attended by several medical device manufacturers and other stakeholders, who made presentations.

On January 30, TOI reported that Niti Aayog has proposed a new law which would ensure quality and efficacy of all medical devices - ranging from blood pressure monitoring equipments, to diagnostic devices like X-ray and MRI machines to high-end stents - sold in the country.

“It was discussed and decided that there is an urgent need to generate data related to all medical devices that are sold in the country. Therefore, a national web portal can be created wherein all manufacturers and importers will be required to register with details about their manufacturing site, product expiry date etc,” an official present in the meeting told TOI.

He added, the website will generate a registration number which the company will have to carry on their product label, enabling traceability.

The committee is again scheduled to meet on Tuesday and has called upon inter-ministerial representations from Niti Aayog, department of industrial policy and promotion (DIPP), department of pharmaceuticals (DoP), department of biotechnology (DBT) and department of science and technology (DST).

The committee is likely to make final recommendations to the health ministry after Tuesday’s meeting.

The medical devices industry in India is pegged at $7 billion and is rapidly growing. The industry is projected to reach $50 billion by 2025. Currently, India is the fourth-largest medical devices market in Asia after Japan, China and South Korea. However, nearly 80% of the medical devices used in India are imported.The Times Of India