Wonder when the pharmacists aka drug inspectors will realize that medical devices are not drugs and need experienced and competent engineers to regulate medical devices. Imagine a B.Pharm auditing a cath lab or a biochemistry automated analyzer factory and insisting why the assembly is not in a class 100 clean room and why stainless steel furniture is not used by staff. This is what happened in the Johnson and Johnson hip replacement case.
According to the Union Public Services Commission (UPSC) advertisement (16/2018) for recruitment of 17 vacancies of Drug Inspector (Medical Devices – MDO) in Central Drugs Standard Control Organization (CDSCO), technology and engineering graduates/post-graduates were invited for the MDO posts. This was what correctly required under MDR- 17 but the state regulator lobby was moved via Drugs Technical Advisory Board (DTAB) to dilute this and seek pharmacists also to be considered as MDO when it took years of efforts to convince CDSCO and MoHFW that we need to move away from inspector raj by misinformed pharmacists.
In a letter sent to the chairman of the UPSC, the All India Drugs Control Officers Confederation (AIDCOC) informed the central recruitment agency that enforcement of drugs laws is legally assigned as the professional duties of drug inspectors with degree in pharmacy or pharmaceutical science or medicine with specialization in clinical pharmacology or microbiology. In the notification of the MDO vacancies, UPSC has omitted pharmacy degree as requisite qualification for the MDOs. The Confederation wanted the chairman to issue a revised notification by incorporating pharmacy degree qualifications (B.Pharm, M.Pharm, and Pharm D) in the eligibility criteria.
This is why we need a separate law to remove the confusion and a separate regulatory authority as clearly stated in GoI MoHFW Health Policy clause 14.5. – Medical Buyer Bureau