The medical device manufacturers in India have written to the Union Ministry of Health and Family Welfare seeking a six-month extension to comply with the rules of quality licensing for high-risk medical devices.
These products — classified under the categories of Class C and Class D under the 2020 amended Drugs and Cosmetics Act — include ventilators, imagining equipment, oxygen therapy equipment, nebulisers, X-ray equipment, surgical robots, oncology treatment linear accelerator, among others.
The industry had been given time till September 30, 2023, to comply with the Medical Devices (Amendment) Rules, 2020. As per this mandate, the medical device manufacturers and importers in India were mandated to get licences for their high-risk category products by October 1, 2023. The transition period of 42 months — to complete the licensing of non-notified Class C and D medical devices — started from April 1, 2020.
While the regulation on Class A and B products — the non-risk medical devices — came into effect from April, 2020, itself, the industry players who were registered, but not licensed on this date, were allowed to continue manufacturing and selling. The regulators, the Food and Drug Administrations (FDA) at the state level and (CDSCO) at the central level, have sought the due compliance and audit certification from them.
The industry is now expecting a similar extension for high-risk medical devices as well. While the industry’s request is understood, given the typical regulatory compliance issues in India, the main reason that it has cited for demanding further extension of the transition period is rather contradictory. The industry association, the Association of Indian Medical Device Industry (AiMED), has pointed to the procedural delay on the part of the regulators for issuing the licence as the reason for its request.
In a letter dated September 25 to the Health Ministry, AiMED's Forum Coordinator Rajiv Nath has sought additional time for compliance citing concerns about the "...resource constraints of the CDSCO in conducting timely inspections and issuing manufacturing licences before the stipulated deadline of October 1 and this may lead to supply-chain disruptions for many Indian-made medical devices.”
Further, AiMED has pointed out that over 1,000 manufacturing licences are in process for 200-300 manufacturers of these high-end, high-risk medical devices — implying that the regulator is unable to complete its inspection on time despite the manufacturers being ready.
Curiously, the CDSCO, which is functioning directly under the Ministry of Health and is responsible for ensuring timely industry compliance, has not updated its parent about the “resource constraints.” Instead, it’s the industry, who is subject to the regulation, which is reporting the same to the ministry. In other words, had the ministry known about these resource constraints it would have acted on its own to ensure the implementation of the law in time.
It can be recalled that the Indian medical devices industry time and again resisted the government’s moves to regulate medical devices on par with drugs. The Medical Devices (Amendment) Rules, 2020, was incorporated within the Drugs & Cosmetics Act for this purpose and it met with strong resistance from the industry.
It is important to set the context for this resistance. India’s medical devices market imports at least 60-70 percent of both high-risk as well as low-risk products from various foreign sources and manufacturers. Several multinational medical device manufacturing giants are also present in this market, though the prices of their imported products are often exorbitant for the typical Indian customer. As a result, many of India's domestic medical devices manufacturers import these products or components from cheaper sources, where quality is often not guaranteed.
Several manufacturers in India have been importing the device components and kits from these so-called sources and just assembling them in the country. Though of late, there is a visible change in the local capabilities, thanks to new-gen technologies and several tech startups, the domestic industry is still not fully capable of meeting the local demand.
There’s no doubt that the government wants patients to have access to good quality products at the locally affordable price by ensuring quality. However, when it comes to the quality compliance, one can only hope the industry should be transparent enough to admit its limitations and more committed to the much-needed changes. And the government should take adequate measures to weed out the inferior products for the sake of the patient, who is the ultimate sufferer.
