In the first significant step towards regulating medical devices in India, the country’s top drug advisory body has recommended that the Centre “notify” all medical devices in the country under the Drugs and Cosmetics Act in a phased manner. Currently, the government regulates only 23 notified medical devices under the law.
The decision comes almost five months after The Indian Express published the Implant Files, a series of investigative reports on the unregulated medical device industry in India where devices are advertised, sold, and surgically implanted under regulatory systems riddled with holes.
The decision to make the recommendations to the Ministry of Health and Family Welfare, which are binding, was taken April 2 at the 82nd meeting of the Drugs Technical Advisory Board (DTAB), the highest statutory decision making body on technical issues related drugs and medical devices in India.
The DTAB is headed by Director General of Health Services, S Venkatesh, and the minutes of the 82nd meeting were Thursday approved by the Drug Controller General of India.
With the DTAB’s decision, the Health Ministry will now be required to issue either separate rules or an executive order based on these recommendations and the Central Drugs Standard Control Organisation (CDSCO), the country’s medical device regulator, will implement the rules thereafter.
On March 14, The Indian Express had reported that an expert committee looking into regulating this sector had made detailed recommendations that medical devices should come under a regulatory regime in a three-phase manner based on risk classification.
In the first phase, the proposal directs all manufacturers and importers of non-regulated medical devices to register their products voluntarily within 18 months after which they will be notified for regulation.
In the second phase, all registered Class A and B devices will need mandatory licensing within 12 months after which no person, company or organisation will be allowed to manufacture, import, sell or distribute Class A and Class B medical devices without a prior licence.
For all Class C and D devices, another 18 months will be given for registration and 24 months more — after
registration in Phase 1 — for mandatory licensing. Those who miss the deadlines will not be allowed to sell, import or manufacture these devices.
Referring to these recommendations, the DTAB has now said, “DTAB deliberated the matter (on regulation of all medical devices in a phase-wise manner) and agreed to notify all medical devices as drug under the Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940, and also to provide exemptions in the Rule 90 of the Medical Device Rules, 2017, during the transition period. The Board further agreed that CDSCO should be strengthened with respect to manpower and infrastructure to regulate all medical devices. The Board further recommended to include dentists and ophthalmologists in the category of experts to be recruited.”
Meanwhile, the Association of Indian Medical Device Industry (AIMED) has raised concerns that many “key strategic
aspects of the Road Map discussed with the Indian Medical Devices Industry Associations are missing” in the minutes of the meeting released on Thursday.
“While we welcome the steps being taken by DTAB to consider to phase regulation of all medical devices, however, we notice with great concern that many key strategic aspects of the road map discussed with the Indian Medical Devices Industry Associations are missing. We had recommended that all medical devices need to be regulated under a separate medical devices-specific law. Also, we wanted the medical device industry nominees and regulatory experts as special invitees on the DTAB and constitution of an expert advisory group to aid the DTAB,” said Rajiv Nath, Forum Coordinator of AIMED.