Indian medical devices sector faces regulatory heat, to undergo stringent checks soon
Stringent quality and price monitoring is to be lined up by the government for stents, catheters, MRI machines and other such medical devices. Separate regulator and law to keep a check on diagnostic equipment, implants as well as hospital equipment available in the country has been recommended by an inter-ministerial task force on medical devices.
The medical devices industry and public health experts are advocating that medical devices should be monitored under separate norms as opposed to the current practice of regulating them under the Drugs and Cosmetics Act with the same provisions of medicines.
The task force, with representation from ministries including ministry of commerce and industry, department of industrial policy and promotion (DIPP), executives from the Confederation of Indian Industry (CII) as well as ministry of health, has suggested formulating a ‘Medical Device Regulatory Act’ for the $6 billion industry. They claim that this will provide dedicated, predictable, transparent, globally harmonized and appropriate regulations for medical devices and will ensure that medical devices are only subjected to device relevant laws and not to those relevant to drugs.
Promotion measures for local manufacturing of medical devices were also suggested by the panel. These included, providing discounts on import of raw material for manufacturing devices and equipment by designing of enabling duty structure, incentives to promote exports and restriction on import of second-hand diagnostic tools. Times of India very recently covered an article on the flood of first world’s discarded medical devices into Indian markets, according to which most equipments are imported by multinational firms and do not undergo proper quality checks due to the lack in our law.
Although happy with the recommendations, the medical devices industry points out that the government’s earlier action of allowing 100% foreign direct investment through automatic route in the sector may hamper local manufacturing. The CII’s medical technology division further emphasized the need for the right balance between access, affordability and return on innovation.
