Medical Devices Regulation — here’s why the industry is seeking an extension at the regulator’s cost

by Rahul Devi

The medical device manufacturers in India have requested a six-month extension to comply with the quality licensing rules for high-risk medical devices. These products, which are classified under Class C and Class D categories, include ventilators, imaging equipment, oxygen therapy equipment, nebulisers, X-ray equipment, surgical robots, and oncology treatment linear accelerators, among others.

The manufacturers were initially given until September 30, 2023, to comply with the Medical Devices (Amendment) Rules, 2020. This mandate required them to obtain licenses for their high-risk products by October 1, 2023. However, the industry is now asking for an extension due to procedural delays in issuing licenses by the regulators.

While the regulation for non-risk medical devices came into effect in April 2020, the industry players who were registered but not licensed on that date were allowed to continue manufacturing and selling. The regulators, the Food and Drug Administrations (FDA) at the state level and the Central Drugs Standard Control Organisation (CDSCO) at the central level, have since sought compliance and audit certification from these manufacturers.

In a letter dated September 25, the Association of Indian Medical Device Industry (AiMED) expressed concerns about the resource constraints of the CDSCO in conducting timely inspections and issuing manufacturing licenses before the deadline. AiMED mentioned that over 1,000 manufacturing licenses are still in process for 200-300 manufacturers of high-risk medical devices, indicating that the regulators are unable to complete their inspections on time.

Interestingly, the CDSCO has not informed the Ministry of Health about these resource constraints. Instead, it is the industry, subject to the regulation, that has brought this issue to the ministry’s attention. This raises questions about why the CDSCO did not report the resource constraints itself, as the ministry could have taken action to ensure timely implementation of the law.

It is worth noting that the Indian medical devices industry has been resistant to government regulations that aim to bring medical devices under the same standards as drugs. The Medical Devices (Amendment) Rules, 2020, incorporated within the Drugs & Cosmetics Act, faced strong opposition from the industry.

The resistance from the industry can be contextualized by the fact that India imports 60-70% of its medical devices from foreign sources, including multinational manufacturers. These imported products often come with exorbitant prices, making them inaccessible to the average Indian customer. As a result, domestic manufacturers often import products or components from cheaper sources, where quality may not be guaranteed.

While there has been progress in local capabilities due to new-generation technologies and tech startups, the domestic industry is still not fully capable of meeting local demand. The government aims to ensure access to good quality and locally affordable medical devices for patients. However, it is important for the industry to be transparent about its limitations and committed to the necessary changes. The government should also take measures to eliminate inferior products for the sake of patient safety.

In conclusion, the medical device manufacturers in India are seeking an extension to comply with quality licensing rules for high-risk medical devices. The industry cites procedural delays as the reason for the request, highlighting resource constraints faced by the regulators. While the government aims to ensure access to quality medical devices, it is crucial for the industry to be transparent and committed to necessary changes. The government should also take measures to eliminate inferior products for patient safety.

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