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Impact Of Higher Duties On Local Mfg Of
Medical Devices
When it comes to Medical Devices, taxation policies actually
go towards its contradictory facet, though PM Narendra Modi has made ‘Make in
India’ a boosting government area. Duties for device manufacture remain very
high and that is the reason why device manufacture in India isn’t feasible. On
the other hand, duties on finished goods have reasonably reduced. It is
astonished that in some products such as Cardiac Stents, the duties have reduced
to zero.
As per some recent survey reports, more than 75% of India’s
medical devices market is totally based on imports, most particularly by the
multinationals that don’t have manufacturing set up in India. MNCs were the
first to be invited for foreign investment in India, but most have used the
chance to set up owned subsidiaries not for manufacturing but only for marketing
activities, stated a white paper on the medical device industry in India.
In India, ‘Medical Device’ term covers the entire range
starting from disposable syringes & gloves to high-end CT scans and robotic
surgery machines.
The indigenous industry consists of over 750 firms primarily
manufacturing low technology products, though a few have been making a slow
transition to producing cost-effective medium-end medical devices. 20% are Rs 10
crore-50 crore companies, 5% are Rs 50 crore-100 crore companies, 3% are Rs 100
crore-500 crore companies and just 2% are 500-crore plus companies. At the
surprise note, 70% are the companies valued at less than Rs 10 crore.
India is following the US model where MNCs dominate and grow
by mergers and acquisitions. This may consequently harm the interests of Indian
consumers, as per Dr Rajiv Nath, forum coordinator of the AIMED. Many other
segments are there such as orthopaedic and dental implants, ICU equipments and
products as well as endoscopes where the import dependency is more than 90%.
Though there are some serious indigenous efforts in the areas of ophthalmology,
due to upturned duty structures and lack of subsidies/incentives for exports
like China and Brazil, even such category is suffering as they are not well
capable to compete with the MNCs.
(Ref:
http://timesofindia.indiatimes.com/business/india-business/Higher-duties-hitlocal-mfg-of-medical-devices/articleshow/43834255.cms)
Medical Devices Industry Demands
De-Listing Of Schedule M-III From Schedule M
The medical devices industry wants the government to de-list
Schedule M-III from Schedule M stating that there is lot of ambiguity and
confusion within the given requirements. They also insisted that to overcome and
properly address the needs of the sector, the government should amend the
existing Schedule M-III to comply with IS 15579/ISO 13485 quality management
system requirements for regulatory purposes.
Even though law clearly specifies Schedule M for pharma,
Schedule M II for cosmetic and Schedule M III for medical devices, industry
contends that the use of word ‘and’ is leading to unnecessary debate and
avoidable conflict between the regulators and the industry. The Association of
Indian Medical Device Industry (AIMED) pointed out that this is because most of
the inspectors incorrectly insist additional compliance to Schedule M as well
which is an overkill for terminally sterilised medical devices.
Rajiv Nath, forum coordinator of AIMED stressed that the most
ironic fact is that the industry has to follow the inadequately defined rules
for all their products even when Schedule M-III is applicable only on three
medical devices out of the 14 notified under the Drugs and Cosmetics Act (D&C
Act). Existing Schedule M-III specifies the requirement for the manufacture of
sterile disposable perfusion and blood collection sets; sterile disposable
hypodermic syringes and sterile disposable hypodermic
needles only.
“The government must understand that the requirement of the
medical device industry is very different from that of pharmaceuticals. They
cannot impose good manufacturing practices (GMP) as followed by the pharma
sector on sterile pharma products on medical devices. We strongly feel that the
requirement of GMP compliance for medical devices should be as per IS: 15579:
(ISO 13485) standards only, as it meets the needs of the industry,” Nath
informed.
Experts feel that the government should take requisite action
at the earliest as the delay in doing so will further affect the industry, which
is already facing the brunt of unfavoured regulatory environment within the
country.
(Ref:
http://www.pharmabiz.com/NewsDetails.aspx?aid=84340&sid=1)
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