Roadmap for Indian Medical Device Industry
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By Rajiv Nath
Forum Coordinator, Association of Indian Medical
Device Industry (AIMED),
New Delhi, Joint Managing Director, Hindustan Syringes
& Medical Devices Ltd.
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Key Initiatives Set By in Motion AiMed
AiMeD has created a dialogue with various government
departments and ministries to highlight the issues faced
by the medical device industry and prepare a strategic
roadmap to address India’s import dependency in medical
devices to reverse it to make India one of the top five
medical devices manufacturing hubs in the world. We have
submitted a defined roadmap and task list with Department
of Industrial Policy & Promotion (DIPP) and Department of
Personnel (DOP) to enable ‘Make in India’. With Ministry
of Health and Family Welfare (MoH & FW) we have requested
for regulations to address patient safety while creating
trust for India-made devices but not of traditional.
License Raj-type relying on inspection by government
inspectors but by unbundling of regulations and ensuring
maximum governance with minimal government and ease of
doing business by utilising third party certification
bodies. Some of the other key initiatives include
Department of Revenue and Tariff Commission a review of
the inverted duty structure that was making imports
cheaper than manufacturing, with Department of Commerce
and Engineering Export Promotion Council (EEPC) a focus is
on creating brand India and a coordinated overseas
marketing plan to unleash our export potential.
Achievements in the HealthCare Sector
More than AiMED’s list let me share the government’s
Progress Report (some of them triggered by aforemen tioned
initiatives) which includes :
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Request to government to address Inverted Duty Structure
and nominal Tariff Protection :
- Revise Basic Duty on Import of Medical Devices to 10% Basic, as earlier
(now 7.5% done on January 19, 2016 for 78 items, 21
pending
- Government to revise special additional duty on medical devices to 4%
as earlier to enable business viability (Done on Jan 19th
2016 for 78 items, rest
21 to be covered)
- Government reduced duty on imported Raw Material to 2.5% on Jan 19,
2016 for above 78 items.
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For enabling consumer protection our proposed tax-based
disincentive are pending. However, steps are being taken
by Department of Consumer Affairs to ensure all medical
devices carry an MRP whether they are an OTC product or
not and NPPA is bringing Stents under price control.
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QCI introduced ICMED 13485 Quality Certification System as
a pre-cursor to medical device regulations for enabling
confidence in quality of Indian products (Done on 15th
March 2016) and have held a series of workshops in Delhi,
Mumbai, Chennai, Pune, Ahmedabad, and Bangalore with
financial support from Department of Commerce on capacity
building of Manufacturers for building QMS - Quality
Management Systems capability development for getting CE
and ICMED Certification. On our request to create a
Separate Rule Book for Devices, the Mo-H&FW responded
favourably and subsequently on 19 October, 2016 the
initial draft of the separate rules to regulate medical
devices was shared with the stakeholders and uploaded on
website for public comments. Comments have been collected
and collated and the draft updated and rules are in
process of notification. Also in response to our request
for a Separate Law from Drugs & Cosmetics Act, a draft
Medical Device Bill has, meanwhile, been prepared by MOH&FW
and is going internal review within the Ministry,
thereafter Stakeholders will be invited for consultations
and thereafter we expect this to be uploaded on the
website for public comments before being presented to the
parliament by ministry.
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On our request to government to review and pull back its
Auto Approval Brownfield FDI Policy - it’s ok to retain
this for 100% Green Field Projects for manufacturing, not
trading - for ensuring choice of Indian brands to Indian
consumers , RBI has initiated investigation on the 100%
FDI policy for potential misuse and its impact.
About Challenges Faced By Indian Medical Devices
Industry
The Indian medical device industry is facing the challenge
of having to compete with imports with deep pocketed MNC
importers and pseudo manufacturers in a very adverse eco
system that is encouraging imports-based trading instead
of manufacturing so that even existing Indian
manufacturers are shifting to imports as that is more
convenient and more profitable than to produce in India.
From being a manufacturing-led economy, India is becoming
a trading and services- led economy in the past decade.
Manufacturing was brought back into focus by the
honourable Prime Minister with his slogan and vision of
Make in India and starting point is to make illegal –
pseudo manufacturers by clearly defining it as falsely and
purportedly claiming to being an Indian manufacturers
without actual manufacturing it in India – manufacturing
site and country of origin needs to be clearly labeled to
ensure transparency and tracking and the site where there
is a value addition of over 40% and there’s a change of
sub-heading of classification indicating transformation of
an output from more than one input so at least it’s an
assembly of components.
How Can Government Facilitate to Make India a Global
Hub For Medical Equipment Manufacturers.
Most of the policy decisions taken in the past have been
based on White Papers published at the behest of MNCs who
are ruling the roost in CII and FICCI – (importers with
overseas manufacturing facilities) who are comfortable to
access the large unregulated Indian market with minimal
tariff barriers and while they make right sounding noises
they have been opposing most of the five corrective
strategic actions suggested by AiMeD that could strengthen
Make in India or help make Indian manufacturers more
competitive and thereby increase their market share, such
as: Tariff Correction, with the plea that it affects
affordability and accessibility to poor patients. Our
contention is being to make manufacturing viable and
profitable as before and reverse ongoing trend of
manufacturers becoming importers / traders. Later domestic
competition will bring down prices. Regulations, (Short
Term Correction of Amending Rules , Schedule MIII,
Guidelines, etc.) with the plea that it would lead to
further confusion and affects accessibility and better to
wait till a law is passed. Our contention being to use the
available short term solutions of administrative circulars
and of executive orders rather than delay till
availability of lengthy legislative process. Mandatory MRP
& Price Capping – With the plea that it will scare away
investment. Our contention being that affordability and
competition is getting skewed - not lower ex-factory price
but higher retail price wins and consumers are suffering
from artificial inflation and domestic manufacturers
suffer from loss of market share unless they match ever
increasing MRP and trade margin. ICMED – Self
Certification and Self Regulation, with the plea that it
creates a parallel mechanism with CDSCO so better to have
only one control and are afraid it could be used as a
non-tariff barrier in due course. Our contention being it
provides credibility to Indian products and low cost
access to local certification rather than getting
expensive overseas certification for CE / ISO 13485 etc.
and respect for Indian brand, a law to regulate all
devices may not be there for a few years and a law can
permit voluntary certification. Preferential Market Access
– With the plea that it restricts access to quality
products in the absence of regulations. Our contention is
it will boost domestic manufacturing and also stop usage
of USFDA compliance as a mandatory qualifying criteria in
many tenders. Why should Indian manufacturers be denied
access to our own Indian market unless they comply with a
foreign country regulatory approval of CE / USFDA ? It’s
unfair. Use ICMED!
(Based On a Recent Interview Published in “eHealth”)
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