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Medical Devices Industry Seeks Regulatory And Pricing
Decisions To Support Make In India
The medical devices industry
is expecting certain regulatory and pricing decisions from
the Central government to sustain the evolving healthy
environment for the domestic medical devices manufacturers
in the country.
The key factors required to
sustain this innovative environment in medical devices in
India include a predictable tariff protection policy. The
industry seeks nominal tariff protection for devices being
made in the country and a predictable tariff policy so if
capacity is added by a manufacturer there is assured
nominal protection.
“To promote domestic medical
device industry that will subsequently reduce India's
heavy reliance on import, the current basic import tariff
of 0-7.5% needs to be 15% for medical device (the Bound
Rate under WTO is 40% duty) and on their components to be
at least 5% & next year 7.5% as a Phased Manufacturing
Programme Make in India Enabler,” said Rajiv Nath, forum
coordinator, Association of Indian Medical Device Industry
(AiMeD).
“Concessional duty on raw
material may be retained at 2.5% for now, for next 3
years. After GST, imported devices are cheaper by 11% and
Indian manufacturers are challenged to compete with
Chinese imports in government tenders even for basic
products like syringes, thermometers, examination gloves &
blood collection tubes,” he added.
With the onset of Covid-19
pandemic, the healthcare insecurity in India was exposed
and the huge over dependence on imports has added to the
impact. Consumers are not gainers from low duties if they
have to pay the misleading excessively artificially
inflated maximum retail price labeled medical devices and
have exposure to inconsistent prices that are linked to a
volatile currency exchange rate.
“If consumer interest needs
to be protected, capping MRP at 4-5 times import landed
price is more effective so the innovative medical devices
have a different MRP labeling rather than turning a blind
eye to MRP as high as 20-30 times the imported landed
price. Design India Certification needs to be given a
preference in public procurement by
price preference for incentivizing Innovation in India and
Innovation in India,” added Nath.
Commenting on the National
Pharmaceutical Pricing Authority (NPPA) capping the trade
margins for essential medical devices like pulse oximeter,
blood pressure monitors, nebulizers, digital thermometers,
glucometers at 70 per cent, he said that the trade margins
need to be rationalised but from the first point of sales
which is when goods and services tax is charged
initially- in case of imports on imported landed prices
and in case of domestic industry based on ex-factory
discounted prices.
Nath added that on many
medical devices the trade margins over import landed
prices will be found to be irrationally high at 10-20
times if investigated. AiMeD has been seeking the MRP to
be capped at 2-4 times the imported products’ landed price
which is the first point of sales and not the price to
distributor which can be the second
point of sales if the government wishes to protect
consumers while seeking to arrest the increasing imports
bill which crossed Rs. 45,000 crore last year.
“The order is biased in
favour of importers. We, on behalf of AiMeD, in a letter
to Mansukh Mandaviya, Union minister of health & family
welfare and chemical and fertilisers, complained that the
whole exercise is non-transparent and applies the same
treatment to both local manufacturers and importers. The
overseas manufacturer Indian importer has been given
advantage to fly their kite with a longer string of
estimated at over 2.6 times import landed price on 2nd
floor, whereas domestic
manufacturers are given shorter string of 1.9 times of
ex-factory from the ground level at a competitive
disadvantage, so why will anyone feel strategically
advantageous to Make in India?” he asked.
http://pharmabiz.com/ArticleDetails.aspx?aid=140660&sid=1,
August 9, 2021
Launch of Good Clinical Practice
Professional Certification Scheme (GCPPCS)
With the global focus on
clinical trials given the COVID 19 pandemic, the
importance of good clinical practice has acquired renewed
relevance to assure that the results of such trials are
reliable and credible. India yet again takes the lead in
rolling out the world’s first certification program for
good clinical practice (GCP) professionals with the launch
of the ‘Good Clinical Practice Professional Certification
Scheme (GCPPCS)’ by Dr. Renu Swarup, Secretary, Department
of Biotechnology, Ministry of Science and Technology,
Government of India in the presence of Dr. Pramod Garg,
Executive Director, THSTI on August 15, 2021, celebrating
Azadi ka Amrit Mahotsav.
Dr. Renu Swarup congratulated
the team for developing a strong framework behind GCPPCS,
mentioning that in our today’s era of various COVID-related
trials (and new drugs, vaccines, devices), the need for
such trained and certified professionals is becoming even
more necessary. She also added that this Scheme launched
on this auspicious day will build capacity and capability
not only for our country but also various other countries.
India is leading the way.
Clinical Development Services
Agency (CDSA), Translational Health Science and Technology
Institute (THSTI) under the Department of Biotechnology (DBT),
after several years of involvement in the development and
training in GCP (Good Clinical Practice), decided to
leverage its strength to create an ecosystem for enhancing
the quality of GCP professionals (clinical
trials/research) at the national level by bringing in a
scheme for certifying training as well as individual
professionals using international best practices like ISO
17024 to support regulation of clinical trials as well as
promote acceptance of Indian training and professionals
abroad. It is the first-in-the globe that such a
certification scheme, based on the growing global trend of
evaluation of competence of the GCP professionals, has
been launched. To gain international acceptance, the newly
launched scheme relies on accreditation of third-party
personnel certification bodies by the national
accreditation body, the National Accreditation Board for
Certification Bodies (NABCB), a constituent Board of the
Quality Council of India (QCI), who have attained
international equivalence for its accreditation.
Dr. Pramod Garg mentioned
that GCPPCS will bring in a paradigm shift on how human
resources are trained and certified in the area of
clinical research/trials. They will now aspire to be
trained and certified thereby enhancing the quality of
clinical trials tomorrow. This was an unchartered path as
there was no standard GCP training or certification system
available to date (nationally or globally). Dr Garg
dedicated this to the nation and signed off as the proud
owner of this scheme led by CDSA, THSTI which the nation
(and globe) will now follow.
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