The medical device industry has hailed the initiatives taken up by the Central government to revise and amend the Drugs and Cosmetic Bill which is expected to get parliamentary nod soon.

At a round table discussion recently, the members of AdvaMed, (the Advanced Medical Technology Association) said that they are encouraged by the new government’s commitment to create a regulatory framework that would help the industry better address the needs of Indian patients.

Addressing a roundtable, Sanjay Banerjee, chairman of the India Working Group of AdvaMed said, “We greatly appreciate the government’s decision to revise the Drugs & Cosmetics (Amendment) Bill.  An appropriate, globally harmonised regulatory environment would enable us to improve access, availability and affordability of medical devices for the Indian patient. The passage of the D&C Bill 2015 will be a significant first step towards recognising medical devices as a distinct and crucial segment of the healthcare sector.”

In India, medical devices currently constitute only 6 per cent of total healthcare spending. Its ability to address the country's growing disease (particularly non-communicable disease) burden has historically been limited by the fact that medical devices are treated as drugs.  Only 14 of the 14000 types of medical devices that exist are recognised in India, and even these are regulated as pharmaceuticals.

“As India’s disease burden transitions from communicable to non-communicable diseases (NCDs), medical technology will have an increasingly important role to play in saving and improving the quality of life of patients. It is particularly heartening that the Prime Minister and his government have taken note of this significance through their recent call to manufacturers to ‘Make in India’ and the decision to allow100 per cent FDI under the automatic route. We believe that the Drugs & Cosmetics (Amendment) Bill 2015 is an essential precursor to achieving these objectives,” said Vibhav Garg, Vice-Chair of the India Working Group of AdvaMed.

Currently members of AdvaMed provide 40 per cent of the medical technology used across the world. According to a 2014 CII-BCG report, within an appropriate regulatory environment, the sector could grow to US$ 50 billion by 2025.

“Going forward, we hope to engage in consistent dialogue with the government to ensure that the distinction between drugs and medical devices is indeed taken to the last mile in every sphere from manufacture to pricing to providing access,” added Banerjee.