“Appropriate regulatory framework, aided with proper government policies could help the industry grow to a USD 25-30 billion in the next ten years,” AdvaMed India Working Group Chair Sanjay Banerji told reporters.
Currently, the size of medical device industry in India is estimated to be around USD 4 billion and represents just 7-8 per cent of the total healthcare industry, he added.
AdvaMed is an association of medical devices makers representing 80 per cent of medical technology firms in the US and its member companies produce more than 40 per cent of medical devices used annually around the world.
In India AdvaMed currently has around 200 members including various medical device manufacturers including Zimmer India, Johnson and Johnson and Stryker. Elaborating on the regulatory framework, Banerji said the recently released Draft of Drugs and Cosmetics(Amendment ) Bill, 2015 addresses several of the industry’s challenges.
“It (bill) is a big leap forward for healthcare delivery and allied sectors in India. This is particularly so in case of the medical devices industry which for the first time has been accorded a distinct status and definition in the bill, he added.
Currently, 14 categories of medical devices and eight additional products are regulated as drugs under the Drugs and Cosmetics Act, 1940. “This is problematic because medical devices are very different from drugs and thus need to be be regulated as a different category altogether,” Banerji said.
Besides, the industry is hoping that issues like risk based classification, separate chapter for clinical trials and separate regulatory entities for the medical devices sector would find space in the new Drugs and Cosmetics (Amendment) Bill, he added. AdvaMed also asked the government to create an ecosystem for the growth of the sector, including allocation of funds for medical technology (medtech) parks in the country. Besides, it also advocated for reduction in the duty on life saving medical devices.