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Manufacturers Welcome Price Cap On
Medical Devices
The Association of Indian Medical Device Industry, which
represents domestic manufacturers, has welcomed the government proposal to
extend price caps to devices including catheters and balloons which are used in
angioplasties.
A government panel has recommended inclusion of these devices
under price control following complaints of overcharging by hospitals. The
National Pharmaceutical Pricing Authority requested the government to classify
balloons and catheters as drugs and include them under the National List of
Essential Medicines.
The government had in February capped the price of stents by
around 85 per cent. The move resulted in increased sales for domestic
manufacturers which are supporting more such actions.
A decision to extend price cap on other devices is expected
to hurt hospitals and impact their margins. Though some large chains believe
price caps could have a short-term impact, given their service diversification,
there is displeasure in the private healthcare service providers over the
government action.
“Pressure has increased on India to revise its stance on
price caps for medical devices and not to extend it to other devices. But the
government should do what is good for the country and give advantage to common
citizens who now have access to the best products at the most affordable prices
and to domestic manufacturers,” said Rajiv Nath, forum co-ordinator, AiMeD.
“In the last six months we have seen a positive trend towards
increased sales for domestic manufacturers. We estimate the trend to continue
and Indian manufacturers will grab 60 per cent of market share by next year,”
Nath said.
Earlier this year the Maharashtra Food and Drug
Administration had examined invoices in 12 major hospitals in the state and
found that over 70 per cent of the cost paid for balloon catheters by patients
is profit margin of manufacturers, distributors and hospitals. In case of
guiding catheters more than 47 per cent of the cost paid by patients was found
to be profit margin of these three stakeholders.
(Ref : Business Standard dated October 12, 2017)
Gujarat Registers Maximum Number Of 170 Medical Devices
Units In The Country Under CLAA Scheme
Gujarat as of today has registered the maximum number of 170
licensed medical device units under the Central Licensing Approval Authority (CLAA)
scheme as against a total of 284 medical device units in the entire country. The
state had 150 such high end medical device units 11 months back and has also
granted licenses to 56 new drug manufacturing units.
The devices currently regulated under CLAA scheme include
cardiac stents, drug eluting stents, catheters, intra ocular lenses, I.V.
Cannula, bone cements, heart valves, scalp vein set, orthopaedic implants and
internal prosthetic replacements.
CLAA has been formed to oversee the regulatory activities
related to grant of manufacturing license for hi-tech medical devices in India.
It aims at ensuring that the medical devices being manufactured in India follow
the standard requirements set by the government to ensure safety, efficacy and
quality of the devices.
The Centre has also been mulling for quite some time for
setting up the medical devices park in Gujarat in a bid to make India
self-reliant in the sector. The creation of manufacturing park for medical
devices will boost the segment of hi-tech medical devices as medical devices
manufacturing requires certain high investment facilities which are too capital
intensive for individual manufacturers to invest upon. A park with in-house high
investment scientific facilities would help manufacturers reduce the cost of
manufacturing by more than 40 per cent to 50 percent.
This will also help facilitate to create an ecosystem for
manufacturing of high end medical device manufacturing aimed at import
substitution and export opportunities and would be a major boost to SMEs.
(Ref :
http://www.pharmabiz.com/NewsDetails.aspx?aid=104308&sid=1 (September
18, 2017 )
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