AiMeD Urges Govt to Extend Deadline for Medical Device Manufacturing Licence Amid Resource Constraints

AiMeD points to resource constraints within CDSCO as a potential bottleneck in the timely issuance of licences, which could disrupt Indian-made medical devices' supply chains.

The Association of Indian Medical Device Industry (AiMeD) has once again appealed to the central government for an extension of the deadline for mandating manufacturing licences for Class C and D medical devices beyond October 1. 

AiMeD cites resource constraints within the Central Drugs Standard Control Organisation (CDSCO) as a potential bottleneck in the timely issuance of licenses, which could disrupt the supply chain for Indian-made medical devices.

AiMeD, the umbrella association representing Indian medical device manufacturers across all categories, sent a letter to Union Health Minister Mansukh Mandaviya reiterating its request for an extended timeline for manufacturing licenses for Class C and D medical devices.

Talking about the urgency of the situation, in the letter, Rajiv Nath, AiMeD's forum coordinator, stated, "CDSCO has apparent resource constraints that may hinder the inspection and issuance of manufacturing licenses by the September 30, 2023 deadline, leading to potential supply chain disruptions for numerous Indian-made medical devices."

According to AiMeD, more than 500 pending licence applications are in the process, and this backlog threatens to disrupt business operations.

AiMeD also proposed an alternative solution by suggesting that manufacturing licences be granted based on audits conducted by notified bodies, a practice already in place for Class A and B medical devices by the National Accreditation Board for Certification Bodies (NABCB) Accredited Certification Body for ISO 13485 certified facilities. 

This approach considers the limited availability of qualified personnel and expertise at CDSCO.The Association also questioned the status of regulators designated for medical devices.

An RTI response revealed that while 236 drug inspectors from a pharmaceutical background had been designated as medical device officers, only 23 inspectors from an engineering background had received similar designations. 

However, these engineering background inspectors had not yet been deployed for inspections of medical device manufacturing units.

AiMeD drew parallels between this situation and deploying the Army to regulate the Navy, emphasizing that overseas manufacturers receive licenses based on ISO 13485. In contrast, Indian manufacturers face a more complex regulatory process involving inspectors with a pharmaceutical background.

The Association voiced concerns about the impending deadline to bring the entire medical device industry under the licensing regime, given the limited regulatory competence in this area.

The Ministry of Health and Family Welfare had previously published a notification on February 11, 2020, outlining the phased implementation of the licecsing regime for medical devices. 

Class A and B medical devices were brought under this regime from October 1, 2022, with Class C and D scheduled to follow suit on October 1, 2023. 

Regulatory infrastructure, such as testing laboratories and qualified regulatory personnel, has consistently been highlighted as essential to ensuring a smooth transition into the new regulatory framework without disrupting the availability of affordable medical devices.