Medical devices lobby seeks 6-mth extension to come under licencing regime

Medical device manufacturers have requested a six-month extension to ensure compliance with mandatory licensing for Class C and D medical devices, as required by the Drugs and Cosmetics Act.

In a letter dated September 25 to Health Minister Mansukh Mandaviya, the Association of Indian Medical Device Industry (AiMED), an umbrella organisation representing domestic medical device makers, sought additional time, citing concerns about the resource constraints of the Central Drugs Standard Control Organisation (CDSCO) in conducting timely inspections and issuing manufacturing licences before the stipulated deadline of October 1.

Rajiv Nath, forum coordinator of AiMED, said in the letter that they are requesting a six-month extension because CDSCO “seemingly has resource constraints for timely inspection and issuance of manufacturing licences by the September 30, 2023, deadline, as this may lead to supply-chain disruptions for many Indian-made medical devices”.

Under the New Medical Devices Regulations, 2020, manufacturers were given a transition period of 42 months, starting from April 1, 2020, to complete the licensing of non-notified Class C and D medical devices.

“Class A and B devices have been regulated since April 1, and manufacturers who were registered but not licensed on April 1 were allowed to continue manufacturing and selling while state and central government regulators sought compliance and audit certification, etc. Similar written clarity is awaited for high-risk medical devices,” said an industry expert.

He added, “We anticipate that over 1,000 manufacturing licences are in the process for 200-300 manufacturers of these high-end, high-risk medical devices.”

Starting from October 1, all Class C and D devices will be subject to licensing requirements under the category of non-regulatory medical devices.

Another industry insider and a medium-scale medical device maker mentioned that without licences, sales cannot be conducted legally. Therefore, they must halt billing without a manufacturing licence.

“We contacted CDSCO, and they informed us that they are awaiting the formal note from Ministry of Health and Family Welfare so that they can then provide clarity on whether sales can be conducted by registered manufacturers in the absence of a licence until such a licence can be issued to manufacturers,” the source said, adding that they are waiting for communication from CDSCO and the Union health ministry.

Medical devices are divided into four classes based on the level of risk they pose. Class A and B devices are categorised as low-risk, whereas Class C and D devices are considered high-risk. These high-risk medical devices that require licensing include life-saving equipment such as defibrillators, ventilators, imaging equipment, oxygen therapy equipment, and nebulisers.