The Union Health Ministry has proposed new legislation that will not only help improve the quality of medical devices but can also bring transparency in the area.
The proposal is aimed at bringing more clarity to the medical equipment sector, which often remains outside the scanner.
The ministry plans to introduce the Drugs and Cosmetics (Amendment) Act, 2015, with two new chapters on medical devices and clinical trials. While in case of clinical trials, a large number of executive rules have been incorporated as law, the chapter on medical devices is completely new.
Currently, 14 notified categories of medical devices—which cover more than 90 per cent of the devices—are deemed to be considered as drugs. Separate recognition of medical devices may lead to administrative ease and bring clarity, said industry insiders.
The Indian medical device market currently stands approximately at $3 billion, but is growing exponentially. More than 75 per cent of the medical devices used in India are imported as there is no indigenous base to manufacture them.
The medical device industry came under the regulator’s scanner in the wake of a controversy in 2005 involving JJ Hospital in Mumbai, which was using imported Axxion stents for cardiac patients without the Central government’s approval.
These drug-eluting stents were not permitted for use in the Netherlands, their country of origin.
Subsequently, the Bombay High Court asked the Union Health Ministry to treat internally used medical devices as drugs, and regulate them accordingly.The new law proposes to create a medical devices technical advisory board, on the lines of a similar panel on drugs, to provide technical inputs in regulatory supervision. In the draft legislation, the ministry has proposed several categories of punishment.
For spurious medical devices causing death and bodily harm, the penalty includes jail terms of up to seven years and fines up to Rs 5 lakh or three times the cost of the device, whichever is higher.
Industry representatives had argued for a lenient punishment regime for the industry before the Parliamentary Standing Committee on Health, which oversaw an earlier version of the bill in 2013.
“There is a need to have a re-look at the punitive clauses with respect to medical devices, as medical technology is still evolving and its knowledge is still developing in the country,” Pawan Chaudhary, the then chairman of the medical equipment division at the Confederation of Indian Industries, told the House panel in November 2013.
