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National Medical Device Authority (NMDA)
- Recommended By Task Force To
Strengthen “Make In India” Drive
The Drugs
and Cosmetics (Amendment) Bill, 2015 for providing a
separate chapter for regulation of the complete range of
medical devices is now under legislative process.
Besides,
the others issues facing the Indian medical device
industry include training and capacity building programme,
interaction with medical device regulators, policy to
promote local manufacture of Medical devices, granting
subsidies and incentives and promoting higher education
relevant to medical devices industry to bring fresh talent
and techniques into research and development. There does
not exist a single nodal authority for medical device
industry.
Recognizing
this policy deficit, the Government constituted a Task
Force under the chairmanship of the Secretary, Department
of Pharmaceuticals (DoP) to address issues relating to the
promotion of domestic production of high end medical
devices and pharmaceutical manufacturing equipment in the
country. The Task Force in its report released by
Honourable Minister of Chemicals and Fertilizers on
08.04.2015 had made a set of recommendations for the
promotion of the Medical device industry.
Objective:
The
National Medical Device Policy-2015 has the objective of
strengthening the Make in India drive in Medical device
sector by reducing the dependence on imports and setting
up a strong base for Medical devices especially those
having critical implications in terms of affordability and
availability for patients.
Salient
Features:
-
An
autonomous body “National Medical Device Authority” (NMDA)
to be created under the Department of Pharmaceuticals;
which may be headed by an officer of the rank of
Additional Secretary/ Joint Secretary to the Government of
India.
The
Authority shall have a Member Secretary of the rank of
Joint Secretary/ Director; two eminent medical
practitioners; two eminent medical device technologists or
scientists; and Secretary General of Quality Council of
India (exofficio). The Authority shall.
-
Provide a single window
mechanism to the industry with an objective of promotion
of the medical device industry to make the country not
only self-reliant but also a global hub of production and
innovation in medical devices.
-
Be responsible for setting up
and managing, through appropriate corporate body/ SPV,
Medical Devices Mega Parks of approximately 500 hectares
and above, of various specialisations in the vicinity of
Centres of Excellence.
-
Create benchmarks as per
international best practices and update all the
stakeholders on global development.
-
Develop knowledge networks
with partners from industry.
-
Identify and prevent creation
of unnecessary and unjustified technical barriers to trade
especially by new or changing technical regulations.
-
Support and prepare indigenous
businesses to face competition, access foreign markets,
and find new business partners abroad.
-
Search, collect, collate and
analyze relevant data.
-
Promote, co-ordinate and issue
guidelines for the development of risk assessment
methodologies and monitor, conduct and forward messages on
the risks associated with medical devices to the Central
Government, State Governments and other enforcement
agencies.
-
Promote networking of national
and international organizations within and outside India
with the aim of facilitating scientific co-operation,
coordination of activities, exchange of information,
implementation of joint projects and exchange of
expertise.
-
Take all such steps to ensure
that the public, medical professionals and interested
parties receive rapid, reliable, objective and
comprehensive information through appropriate methods and
means.
-
Promote general awareness as
to medical device safety and medical device standards.
-
Undertake any other task
assigned to it by the Central Government.
-
ii The Government on the
recommendations of NMDA, subject to availability of
Budgetary resources, may consider all or an appropriate
mix of the following incentives for both Greenfield and
Brownfield units:
-
Preference in government procurement
may be considered for medical devices which are being
manufactured in India with an additional preference for
medical devices manufactured under MSME sector.
-
R&D by agencies like ICMR, DBT, CSIR,
DIETY & DoP should be supported/ coordinated through the
single window facilitating body.
-
Low cost funding like interest subsidy
to MSME
-
Concessional power tariff for up to
5-10 years
-
Provide seed capital, viability gap
funding and co-fund startup projects
-
Support commercialization of
innovations
-
Provide longer term view (10 years
window) for 200 % weighted tax deduction on approved
expenditure on R&D as the gestation period in high in this
industry.
-
Tax/ duty structure to be designed to
promote local manufacturing of quality medical devices and
diagnostic equipment
-
Minimum/ zero duty on the import of raw
materials and manufacturing equipments for production of
medical devices.
-
Restrictions on import of second hand
diagnostic equipment/tools
-
Higher taxes after 5-7 years of usage
for imported second hand devices
-
Incentivize and promote exports in the
medical devices sector.
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