Over 200 manufacturers of certain types of medical devices have been compelled to stop the supply of their products after their applications for manufacturing licences under a newly applicable law were not approved before the cutoff date of October 1, 2023.
Over 500 applications for manufacturing licences of high-risk Class D and moderately high-risk Class C medicines are pending with the regulator, the Central Drugs Standard Control Organisation (CDSCO), estimates Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMED).
The class C & D medical devices that cannot be sold without a manufacturing licence from October 1 include defibrillators, ventilators, imaging equipment, oxygen therapy equipment, nebulisers, X-Ray equipment, surgical robots, oncology treatment linear accelerator, etc.
AiMED says the association had sought an extension for the implementation of the licencing requirement as CDSCO doesn’t have the resources to issue manufacturing licences to all applicants.
“Today the competent manufacturers should have got their licences issued. But since that has not been done, they cannot do sales legally. We are seeking clarity from the ministry as legally from today sales need to stop and no billing is possible without a manufacturing licence”, rues Nath.
According to him, CDSCO needs a formal note from the Ministry of Health before they can clarify whether sales can be done by registered manufacturers in the absence of licences.
In a letter on September 25, the AiMED sent a representation to the health minister seeking a six-month extension to the timeline needed to comply with the licencing norms. Pending the new approvals, they wanted the CDSCO to issue manufacturing permits on the basis of audit by notified bodies as is being done for other categories (Class A & B) of medical devices by NABCB Accredited Certification body for ISO 13485 Certified manufacturing facilities. The association also had sought clarity from CDSCO on the actual number of pending applications to understand the gravity of the situation.
Medical Devices of class C & class D had to come into licencing regime under the Drugs and Cosmetics (D&C) Act as per Medical Devices Rules of 2017 with effect from October 1, 2023.
