|
Industry Urges Govt. To Re-Draft D&C
Act (Amendment) Bill To Meet Domestic Manufacturers’ Requirements
The medical devices industry in the country is pushing for
major reforms in the D&C Act (Amendment) Bill 2015. Concerned by the lackluster
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.
They want the government to rename 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 ISO13485 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 these guidelines should be notified as rules.”
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 labeling 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, and even after sympathetic
assurances, it is yet to see any conclusive decision making.
(Ref:
http://pharmabiz.com/NewsDetails.aspx?aid=86170&sid=1)
|
