AiMeD flags Centre’s notification on Medical Device Vertical Recruitment Rules, 2024

AiMeD has flagged the Centre’s new notification  on the Ministry of Health and Family Welfare, Directorate General of Health Services, Central Drugs Standard Control Organisation, Medical Device Vertical (Group ‘A’ and ‘B’ Posts), Recruitment Rules, 2024.

In response to a gazette notification dated November 6, 2024 issued by MOHFW, visit, Gazette Notification – Medical Device Vertical (Group ‘A’ and ‘B’ posts), Recruitment Rules, 2024.

Rajiv Nath, Forum Coordinator, AiMeD has objected to the method of regulating the recruitment to the posts of Additional Drugs Controller, Joint Drugs Controller, Deputy Drugs Controller, Assistant Drugs Controller and Drugs Inspector (Medical Devices) (Group ‘A’ and ‘B’ Posts) in the Central Drugs Standard Control Organisation, Directorate General of Health Services, under the Ministry of Health and Family Welfare.

He maintains that the government had earlier appointed 23 drug inspectors from engineering backgrounds. And, till  the end of 2023, they had not been confirmed as medical device officers. Instead, the government redesignated 236 drug inspectors from pharmacy backgrounds without adequate competency development. It has led to hardship for medical device manufacturers as their factories are being scrutinized by drug background experts. It’s like seeking Airforce Cadets to be qualified by naval or army instructors.

“The growth of the medical devices industry must be unshackled from the Drugs Regulatory regime and have a separate regulatory division independent of Drugs as is the case of FSSAI manned by competent and trained staff, without pharmacists with bias of drugs based regulations. The separation had started by the separate medical devices rules and last year the Parliament Committee on Health recommended in its report 138 and re-asserted in its report 146 of the need for India to have a separate regulatory framework and regulator for medical device considering the vast difference in diverse technologies and risk management approach for engineered medical devices that are not chemistry based pharmaceuticals and we recommend that these regulations need to as per best international practices.

We regret that this notification was passed without consulting the industry or being tabled to the Medical Devices Technical Advisory Group. The pharmacy background regulators will be happy with the recent announcement, as they feel now they will be promoted also to medical devices vertical as posts have been made: ADC/DDC/JDC,” says Nath.
MB Bureau