The medical devices industry in the country is pushing for major reforms in the D&C Act (Amendment) Bill 2015, as it feels that the Bill in its present form does not meet their expectations or ease their issues in the least. Concerned by the lacklustre attitude in which the Bill has been drafted for the struggling medical devices sector, the Association of Indian Medical Device Industry (AIMED) has urged the Centre to re-draft the Bill again, by taking into consideration the recommendations of the industry.
Experts stressed that the new Bill is creating a lot of confusion and chaos within the industry as it is tailor made to suit the pharma and MNCs needs than the domestic manufacturers' requirements. Industry has always maintained that the Drugs and Cosmetics Bill 2015 should be named as Medical Devices and Patient Safety Bill 2015, to be presented as entirely separate regulations from pharma to encourage investment in this segment.
Thus as a first step, they want the government to re name the regulatory body as Indian Healthcare Products Regulatory Authority (IHPRA) under the health ministry with separate divisions for drugs, cosmetics, medical devices and diagnostics.
Likewise, medical device manufacturers want the Centre to define GMP compliance as per IS:15579/ISO 13485 and delink Schedule M of pharmaceuticals from Schedule M III for medical devices in Rule 76. This is because while the importers get license on the basis of third party certification of ISO 13485 in three to four months, Indian manufacturers and exporters have to go through a joint inspection process for compliance to unknown and incompletely defined requirements.
According to Rajiv Nath, forum coordinator, AIMED “Requirement of GMP of sterile pharmaceutical is arbitrarily applied as an overkill forcing the Indian manufacturers to face harassment and delay to make costly corrections for ever changing requirements. The Centre also needs to re-define risk proportionate infrastructure requirements of Schedule M III. As these are listed in CDSCO’s website as guidelines but not followed by inspectors. We strongly feel that these guidelines should be notified as rules.”
Similarly, the industry wants the Centre to take immediate action on correcting the definition of manufacturer in the Bill, as the current one is not appropriate in Indian context and can be misused. Nath cautioned that the definition as proposed will allow importers and MNC’s to claim ‘made in China’ products to be labeled as made in India and claim to be manufactured by them.
“If proposed definition is allowed by law by oversight of our law makers it will be in conflict with labelling requirement of the Indian consumers protection act and the packaging rule and can even be misused and misrepresented by trading companies especially international MNC traders who will pass of the product as if manufactured by them rather than as marketed by them in their brand name on the labels. We fear that it will hurt the interest of the domestic Industry, especially since many world bank financed tenders and state government tenders have clause giving a 10 to 15 per cent price benefit to the indigenous company to encourage a local long term supply source. If a Trader is going to be allowed to print his name as ‘manufacturer’ of product this will take away the competitive benefit being given to domestic producer,” pointed out Nath.
He said that for over nine years the industry has been urging almost the same issues to various officers, committees and task forces and even after sympathetic assurances, it is yet to see any conclusive decision making.