Refer - Financial Express
Enrich the answer from other sources, if the question demands.
IAS Parliament 6 years
KEY POINTS
· Devices do need to be regulated but, once again, the DTAB (Drugs Technical Advisory Board) has suggested forcibly notifying all medical devices that are engineering products as ‘medicines’ under the Drugs & Cosmetics Act and the road-map being defined by it does not entail migrating these to a separate ‘Medical Devices Act’ in due course.
· The medical devices market in India is over $10 billion (`70,000 crore) and projected to grow to $50 billion by 2025 and is the fourth-largest in Asia.
· It’s imperative to have a separate law as devices are engineering items and not medicines—an X-ray machine by no stretch of the imagination can be called a drug, and, so, continued attempts to regulate devices as drugs is illogical and incorrect unless assured that it is a temporary measure.
· Patient safety is more complex with devices where the same are ‘a shared responsibility of the manufacturer, medical practitioners, product user and the regulator’.
· The Drugs Act itself needs reforms as it does not uniformly and equitably regulate quality from state-to-state in the absence of a national singular regulatory authority and there is no point of replicating this limitation for devices too.
· Medical devices manufacturers need to know the legal requirements, penalties, rules and roles that every stakeholder in the system needs to follow, in a predictable manner.
· This will attract overseas and Indian investments. Presently, investors shy away from an unpredictable, incomplete and incorrect regulatory environment.
Road-map for a robust Medical Devices Law
· Medical Devices Rules (MDR), initially experimenting with a few electronic devices under the MDR, the MDR to be amended as per experience gained after 6 months of introduction.
· The National Accreditation Board of Certification Bodies is already accrediting certification bodies for voluntary quality assurance (the Indian Certification for Medical Devices (ICMED) scheme) under the QCI (Quality Council of India).
· Incentivizing ICMED certification by the QCI will help manufacturers in capacity building for voluntary compliance to quality standards, thereby ensuring global competitiveness and enabling the smooth transition to mandatory compliance under a Patient Safety Medical Devices Law.
