The government is mulling a single overarching watchdog – similar to US Food and Drug Administration (US FDA) – to oversee functioning of three regulators of food, drugs and medical devices.
The move is aimed at streamlining regulatory structure while ensuring transparency, effective monitoring as well as ease of doing business.
At present, both medicines and medical devices are regulated by the Central Drugs Standard Control Organisation (CDSCO), whereas food along with nutraceuticals are monitored by the Food Safety and Standards Authority of India (FSSAI). Both CDSCO and FSSAI heads report to a joint secretary in the health ministry.
Government think-tank NITI Aayog has floated a proposal suggesting a separate third vertical for regulating medical devices similar to CDSCO and FSSAI. It has also recommended that instead of reporting to a JS, all the three verticals can be supervised by FDA India head who will be an IAS officer of the rank of additional secretary in the health ministry, official sources said.
“NITI Aayog’s suggestion has found favour with the PMO and is likely to be implemented soon,” a senior official told TOI.
“It is important to restructure the regulators because while much of these are pharmaceutical products or products concerning the health of people, they are different in their making, design, technology, usage as well as marketing and distribution. It is unfair to regulate medical devices as medicines. At the same time, it is important to have somebody overseeing them from a health perspective,” the official said.
The NITI Aayog’s proposal has also been endorsed by industry which says the move will be in line with international standards and procedures and therefore, will help ease regulatory approvals for Indian companies in other countries.
All the three sectors – pharmaceuticals, medical devices and food – are fast growing industries in the country with rapidly increasing consumption of such products. The Indian drug manufacturing industry – which clocked a local annual sales of over Rs 1,36,000 crore – is also the third largest export revenue churner. The medical devices industry, currently pegged at around $7 billion in India, is rapidly growing and projected to touch $50 billion by 2025. The Indian food market, valued at $39.71 billion, is also one of the fastest growing industries in the country.
“An overarching body like FDA India will help enhance the brand value and establish a credibility by way of uniformity. It is often difficult and sometimes even embarrassing for us in other regulated markets to seek clearances for our products because they are certified by authorities or organisations with no global recognition,” a medical device manufacturer said.
The Aayog has also been pushing for a separate law or Act to regulate medical devices. The proposal for the bill also recommends a separate regulatory authority for medical devices and an overarching body headed by health ministry. The proposal is in final stages of discussion with an inter-ministerial note circulated to different ministries. – Times of India