Bill separating medical electronics & devices from drugs soon | SupportBiz

Policy Notes

Bill separating medical electronics & devices from drugs soon

The Ministry of Health & Family Welfare has proposed a new Bill bifurcating medical electronics & devices as separate entities from drugs. The Bill will be presented in Parliament soon and once enacted as law, it will give medical devices sector a new lease of life.

This was disclosed in New Delhi recently by Dr. A K Panda, Joint Secretary, Ministry of Health & Family Welfare, while addressing the global congress on ‘Investment Opportunities in Medical Electronics & Devices’ organized by FICCI in association with the Ministry of Health and Family Welfare on the theme ‘Harnessing Medical Technology for Inclusive Healthcare in India.’

The biggest challenge that the medical devices sector faces is in the realm of regulation as the Drug & Cosmetics Act, 1940 does not define medical device anywhere in the Act. Hence, medical devices are currently notified as drugs under the current framework of the law. Therefore, all the attending rules and regulations of the Drug & Cosmetics Act, which were designed for drugs (pharmaceuticals), were applicable to these medical devices.

Dr. TKA Nair, Adviser, Prime Minister’s Secretariat, remarked that in the healthcare sector the well-being of people was of utmost importance. He said the high cost of healthcare was one of the most significant challenges that the sector today faces.

He said it is important to keep a check on the quality of healthcare because it is often seen that in trying to curtail the cost of healthcare, the quality suffers. Hence, the time had come to find solutions to lower the cost of medical facilities keeping the quality in line with international standards.

Dr. Nair also pointed out that regulations play a major role and it is necessary to deal with healthcare in a holistic way.

Dr. Panda said that for the first time in the 12th Plan, the Government of India has allocated Rs 1800 crore to extend financial support to states and UTs to strengthen the regulatory system of medical electronics and devices in the country. The major part of this grant will be spent on procuring technically qualified manpower and establishing more laboratories, training academies, diagnostic labs, and capacity building.

He also proposed that an institutional mechanism should be set up where on a regular basis the relevant stakeholders from the sector could come together and deliberate on the latest developments in the medical devices field and also discuss the challenges and issues that arise with the fast changing technology.

Gautam Khanna, Chairman, FICCI Medical Device Forum & Executive Director – Healthcare, 3M, stated, affordability of healthcare has been a major issue. He suggested that instead of trying to make the healthcare facilities cheaper, we should look at innovative methods to raise the financing capacity of the people and ability to pay through insurance could be one such way.

India’s medical devices market is of almost $3 billion and is growing at a rate of 15 per cent. Hence the growth potential is immense and now healthcare is also a top priority for the government, he added.

“Technology is making healthcare more accessible and popular. We also need to spread awareness about non-communicable diseases and PPP solutions must be explored further to strengthen the sector. The government has already launched few programmes in this regard but a greater push is needed,” Khanna said.

Sanjay Banerjee, Co-chair, FICCI MDF & MD, Zimmer India, said there was an urgent need to address the issue of legislation and it was encouraging for the sector to know that the Ministry of Health & Family Welfare has proposed a new Bill in this regard in Parliament.

Dr. A Didar Singh, Secretary General, FICCI, said that India lacked technology and investment in this sector. “We should import technology from abroad and also look for ways to acquire investments from overseas. Then medical equipment and devices could be produced and manufactured in India and the cost of healthcare will eventually come down,” he added.


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