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MtaI opposes DoP's notification bringing stents under price control
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Our Bureau, Mumbai
December 23 , 2016
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Opposing the recent decision of the government to bring stents under
price control, the Medical Technology Association of India (MtaI) has
urged the Department of Pharmaceuticals (DoP) to have a holistic view on
the decision by involving all the concerned stakeholders i.e.
hospitals, physicians, companies in the discussion on price regulations
to arrive at a decision which is best for patient health. It also asked
the government to create a vibrant environment for the medical device
sector to make innovative therapies accessible to patients and uphold
& strengthen the state of healthcare already achieved in the
country.
Terming that the decision to bring stents under price
control disregards the innovative nature of the medical technology
sector, the association urged the pricing authority to use scientific
rationale in the decision making instead of using broad-brush of drug
rules on this small yet highly innovative and vital life-saving sector. A
non-scientific implementation may lead to major obstacles in the
natural evolution of this sector and create implementation snags leading
to morbidity and mortality traps, it said.
“We have been
surprised and disappointed with the decision of including the category
of drug eluting stents under Schedule 1 of Drug Price Control Order,
2013. The industry has been working closely with the pricing authorities
to bring transparency on the pricing issue and arrive at scientific
methodology to differentiate among various value-added versions of drug
eluting stents. The decision disregards the innovative nature of the
medical technology sector which has evolved over the last 20 years
globally and is still evolving,” MtaI in a statement said.
MTaI
is also deeply concerned with the treatment implications on patients,
who may need different and innovative products for their individual and
evolving medical needs. Such a decision would not only take away a
clinical choice from a physician, to use different products for
different patient needs but also take away patient’s right to choose for
their own medical care based on quality and innovation of a product.
Over
the last 10 years, medical technology sector in India has been
struggling to get a distinct identity with clear definition in Drugs and
Cosmetics Act of India. Any decisions like this without resolving the
fundamental issue on medical device regulation further complicates the
matter for all stakeholders. In fact, the industry has taken a number of
steps to drive access of the advanced medical technologies for a large
pool of patients with its voluntarily offer to provide one type of
high-quality, FDA approved stent at a CGHS approved rate of Rs.25,000
to the pricing authorities few months back. In addition, it is
partnering with a number of state government reimbursement programs by
providing world-class products at the lowest prices. Hence, to enable
patient access without compromising patient health and quality of
outcomes, we urge the pricing authority to use scientific rationale in
the decision making instead of using broad-brush of drug rules on this
small yet highly innovative and vital life-saving sector. A
non-scientific implementation may lead to major obstacles in the natural
evolution of this sector and create implementation snags leading to
morbidity and mortality traps, it said.
It will also slow down
the progress of the medical tourism sector which is expected to grow to
$8 billion by 2020 and dent India’s image as a healing destination for
the world. By shrinking the market it will hurt the Make in India
ambition, where FDI in this sector had begun to start showing a sharp
growth post the current government brought it on the automatic route.
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