Concerned by the repeated failure in addressing the mounting issue of domestic players, medical device manufacturers want the government and regulators to enact strong regulations that will give credibility to Indian manufacturers and facilitate growth of Indian industry. Experts stressed that there is a need for level playing field for the devices already notified as drugs as an interim measure until a long-term appropriate legal regulatory framework is created.

Industry insiders stressed that it is high time for the government to intervene and provide a conducive environment for growth to prevent and protect the industry from disintegrating further. The Association of Indian Medical Device Industry (AIMED) said that the regulators can provide guidance to the industry in meeting its legal obligations for ensuring safety of patients by formulating it in line with the guidelines prescribed by international global harmonisation task force (GHTF) for regulating medical device.

According to the association, this will not only enable mutual recognition by overseas regulators, but will also ensure the facilitation of new and innovative technologies while keeping in mind essential requirements for ensuring patient safety. This demand comes in the wake of lack of any substantial steps taken by the government to help the industry despite repeated remainders and call for actions in the past nine years.

AIMED informs that while most countries draft regulations to protect the interest of the domestic manufacturers, India does exactly the opposite by providing red carpet for importing MNCs. Interestingly, countries like Japan, Taiwan, Thailand and China already have in place measures to promote the domestic industry through overly protective non tariff barriers, while India has made it is easier to import and more difficult to produce in India by Indian or foreign investors.

Rajiv Nath, forum coordinator of AIMED points out that while there has been a single window licensor CLAA for importers with no inspection, domestic manufacturers have been grappling with applications at three levels i.e. state, zonal and CLAA with joint inspection. While Indian companies had to comply with sterile pharmaceutical GMP; MIII and M Part1-A, their foreign counterparts have to comply to ISO 13485 and TECH FILE only.
 
He said, “Even after multiple representations over 9 years, the government has not been able to address the problem of existing manufacturers of the devices notified as drugs by suitably amending the rules and issuing the needful guidelines. Infrastructure also needs to be developed for enabling regulations of medical devices appropriately.”

AIMED also suggested that the current CDSCO's role could be enlarged with more autonomy and could be renamed as the Indian Healthcare Products Regulatory Authority (IHPRA) with decentralised divisions for drugs, cosmetics, medical devices and diagnostics.