High-Risk Medical Device Manufacturers Halt Production Facing Regulatory Hurdles

The recent regulatory changes dictate that medical devices categorised as class C and D, encompassing items such as ventilators, imaging equipment, oxygen therapy equipment, nebulisers, x-ray equipment, surgical robots, and oncology treatment linear accelerators, are prohibited from being sold without a valid manufacturing licence from October 1 onwards.

High-risk medical device manufacturers have temporarily ceased production as they await manufacturing licences from India's drug regulator. This pause in production comes in response to the Central Drugs Standard Organisation (CDSCO) setting an October 1 deadline earlier this year for bringing 'class C' and 'class D' medical devices under regulatory control to ensure quality standards.

Under the new regulation, medical devices falling into these categories cannot be sold without a valid manufacturing licence starting from October 1. The device categories included under this regulation are: ventilators, imaging equipment, oxygen therapy equipment, nebulisers, x-ray equipment, surgical robots, and oncology treatment linear accelerators.

Several manufacturers have reported that they submitted licence applications in July but are still awaiting audits, which will determine whether they receive the required licences.

"There is no information or communication from the health ministry or drug regulator on the issuance of licenses, and consequently, we have stopped manufacturing. Legally, we can't manufacture from October 1," stated a manufacturer specialising in equipment for newborns.

Rajiv Nath, the forum coordinator for the Association of Indian Medical Devices Industry, expressed concerns about potential disruptions in the supply chain.

He said, "The medical devices supply chain may experience disruptions for moderately high-risk and high-risk (class C and D) devices due to the absence of manufacturing licenses, which have not been issued even to those manufacturers who registered and applied for licenses."

This regulatory initiative is aimed at enhancing the quality and safety standards of medical devices, ultimately benefiting patients and healthcare providers.

However, the temporary pause in manufacturing highlights the need for efficient regulatory processes to ensure that manufacturers can continue to supply critical medical equipment without interruption.

In July, the Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, announced plans to bring all four categories of medical devices (A, B, C, and D) under regulation by October 1. Previously, only categories A and B were regulated, but this expansion aimed to enhance the quality standards in the manufacturing of medical devices.

On April 26, the Union Cabinet approved the National Medical Devices Policy, 2023, with a primary focus on improving quality controls within the sector. In 2020, the medical devices sector in India was estimated to be valued at $11 billion (approximately INR 90,000 Cr), contributing 1.5% to the global medical device market.

In a recent announcement, Union Health Minister Mansukh Mandaviya declared India's commitment to becoming a global hub for medical technology and devices. During his address at the India MedTech Expo 2023 curtain-raiser event last month, he highlighted the sector's remarkable potential, with projections indicating its growth to a remarkable $50 billion industry by 2050.  

Minister Mandaviya also emphasised the burgeoning status of India's medical device sector, labelling it a "sunrise industry." He underlined the government's determination to establish India as a leading manufacturing centre for medical equipment and devices.