Shortage of Trained Officer & Lack of Skilled & Competent Visiting Officers to medical devices manufacturers factories expose the technical knowledge bankruptcy of the Regulatory Mechanism
Rajiv Nath, Forum Coordinator of AiMeD in a statement to the press expressed disappointment the Government’s vision to tackle the situation leading to panic amongst the Medical Devices Manufacturers.
The govt had earlier appointed 23 Drugs Inspectors from engineering background but to our knowledge till end of 2023 not appointed them as Medical Devices Officers. Instead, the Government redesignated 236 Drugs Inspector from pharmacy background as Medical Officers without adequate competency development that’s been leading to hardship of medical devices manufacturers as their factories are being scrutinised by Drugs Background experts. It’s like seeking airforce cadets to be qualified by naval or army instructors. It’s imperative for the growth of the medical devices industry to 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 Medical Devices Technical Advisory Group as now Pharmacy background regulators will be happy with the recent announcement as they feel now they will be promoted also to Medical Devices vertical as post have been made ADC I DDC I JDC I as these have
Not specifically restricted qualifications for Medical Devices vertical as being relevant engineering and science based as desired for medical devices and current CDSCO and SLA are already dominated with Pharmacists background regulators.
