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Ministry of Chemicals and Fertilizers

Dr Mansukh Mandaviya launches

National Policy on Research and
Development and Innovation in
Pharma-MedTech Sector in India
 and Scheme for promotion of
Research and Innovation in Pharma
MedTech Sector (PRIP)

“Today is a historic day, an inflection

point in the journey of "Atmanirbharta"
in the pharma & medical devices
sector. We need to transform Indian
Pharma & MedTech sectors from a
cost-based to a value-based &
innovation-based industry”

The scheme will focus on transforming

India into a high-volume, high-value
player in the global market of
pharmaceuticals, meeting the quality,
accessibility, and affordability goals. It
will also enhance our share in the
global value chain: Dr Mansukh
Mandaviya

“India can only achieve self-reliance in

pharmaceuticals and medical devices
by strengthening its research and
development infrastructure that would
drive the expansion of access to life-
 saving medicines and drugs and help
India become a global pharmaceuticals
and medical exports hub”
Posted On: 26 SEP 2023 1:53PM by PIB Delhi

“Today is a historic day, an inflection point in

the journey of "Atmanirbharta" in the pharma
& medical devices sector. We need to
transform Indian Pharma & MedTech sectors
from a cost-based to a value-based &
innovation-based industry.” This was stated
by Dr. Mansukh Mandaviya, Union Minister of
Chemicals and Fertilizers and Minister of
Health & Family Welfare, Government of India
at the launch of National Policy on Research
and Development and Innovation in Pharma-
MedTech Sector in India and Scheme for
promotion of Research and Innovation in
Pharma MedTech Sector (PRIP) today. Dr V.
K. Paul, Member, NITI Aayog, Ms. S Aparna,
Secretary (Pharma), Ministry of Chemicals
and Fertilizers and Dr Rajiv Bahl, Director
General, ICMR were also present at the event.
Accentuating the benefits of the scheme, Dr
Mansukh Mandaviya noted the scheme will
focus on transforming India into a high-
volume, high-value player in the global
market of pharmaceuticals, meeting the
quality, accessibility, and affordability goals.
He further stated “The policy will help to
create an ecosystem of skills and capacities
including the academia and the private
sectors, and give impetus to new talent
among the youth through start-ups.” This is a
transformative stage in the Indian drugs and
med-tech sector, he stressed where
synergies are being created between various
Government institutions and agencies such
as Pharma Deptt., ICMR, DST, DBT, NIPER
etc.
Reiterating the slogan of ‘Jai Jawan, Jai
Kisan, Jai Vigyan and Jai Anusandhan’, he
elaborated that India prioritizes growth and
innovation in brain power and manpower,
wherein Covid is an example where we stood
the testimony of the time. We need to do
mass production of our pharmaceutical
products and medical devices. For this, we
have made three bulk drug parks in
Himachal Pradesh, Vizag and Gujarat and
four medical device parks in Himachal
Pradesh, Uttar Pradesh, Madhya Pradesh and
Tamil Nadu, which will help in strengthening
this sector.

Emphasizing on the importance of the

scheme, the Union Minister of Chemical and
Fertilizer, Dr Mansukh Mandaviya said, “India
can only achieve self-reliance in
pharmaceuticals and medical devices by
strengthening its research and development
infrastructure that would drive the expansion
of access to life-saving medicines and drugs
and help India become a global
pharmaceuticals and medical exports hub.”
We need to make policies, new products and
new research according to the needs of our
country and the world, in consultation with
industries and academia. We should become
so independent that we should not be
dependent on anyone for our critical needs.”

Dr V K Paul, Member (Health), NITI Aayog

said that after learning lessons from the
past, India is leading the world. These
clusters of reforms will transform the
Pharma MedTech Sector. We also need to
focus on collaboration between academia,
public and private institutions. This scheme
and these initiatives will help in preparing us
for the future challenges and ensuring
national bio security.

Senior officials from the Ministry of Health

and Family Welfare and Chemicals and
Fertilizers were also present at the event
along with policymakers, experts from the
healthcare and pharmaceutical sector,
representatives from academia, think tanks,
industry and media.

About National Policy on Research and

Development and Innovation in Pharma
MedTech Sector in India

1. As per the Allocation of Business Rules,

the Department of Pharmaceuticals has
been assigned, amongst others, the work
related to promotion and co-ordination of
basic, applied and other research in areas
related to the pharmaceutical sector;
education and training including high end
research; international co-operation in
pharmaceutical research, inter- sectoral
coordination and all matters relating to
National Institutes of Pharmaceutical
Education and Research (NIPERs).
2. Indian pharmaceutical industry is the 3rd
largest pharmaceutical industry in the world
by volume with current market size of around
USD 50 Billions. The industry could
potentially grow to USD 120-130 Billion over
the next decade; one of the key drivers for
this growth to be expansion of the industry’s
presence in the innovation space.

3. Pursuant to recommendations of the

Parliamentary Standing Committee in its 46th
Report, the Department had constituted a
High level Inter- departmental Committee to
draft and finalize Policy on R&D and
Innovation including Academia-industry
linkage in Pharmaceuticals & Medical
Devices consisting of senior representatives
of ministries/ department and industry
leaders submitted its report in September,
2020.

4. Based on recommendations made in the

Report, Draft ‘Policy to Catalyse R&D and
Innovation in the Pharma MedTech Sector in
India’ has been prepared to encourage R&D in
pharmaceuticals and medical devices and to
create an ecosystem for innovation in the
sector in order for India to become leader in
drug discovery and innovative medical
devices through incubating an
entrepreneurial environment. The policy has
been notified in gazette on 18th August,
2023. The Policy postulates three main areas
of focus to achieve the objectives:

• To create a regulatory environment that

facilitates innovation and research in product
development, expanding the traditional
regulatory objectives of safety and quality.

• To incentivize private and public investment

in Innovation through a mix of fiscal and non-
fiscal measures.

To build an enabling ecosystem

designed to support innovation and
cross-sectoral research as a strong
institutional foundation for sustainable
growth in the sector.

5. It is also proposed to set up an Indian

Council of Pharmaceuticals and Med-tech
Research and Development to facilitate and
promote collaboration among industry,
academia and research institutions across
Departments, promoting domestic and
international collaboration in R&D in Pharma
Med-tech sectors.
6. The policy will lead to higher contribution
in the GDP of the 5 Trillion economy;
increased exports and forex inflow; increase
in global market share; increased drug
security and availability; improvement of
overall healthcare index and reduced disease
burden; creation of high-end jobs in R&D and
Innovation and opportunity to attract back
Indian talent with expertise in R&D and
Innovation.

About PRIP (Promotion of Research and

Innovation in Pharma MedTech Sector)

1. Indian pharmaceutical industry is the 3rd

largest pharmaceutical industry in the world
by volume with current market size of around
USD 50 Billions. The industry could
potentially grow to USD 120-130 Billion over
the next decade; one of the key drivers for
this growth to be expansion of the industry’s
presence in the innovation space.

2. At present a major component of Indian

exports are low value generic drugs while a
large proportion of the demand for patented
drugs is met through imports. This is
because the Indian Pharmaceutical sector
lacks in high value production along with
world class pharma R&D. In order to
incentivize the global and domestic players
to enhance investment and production in
these product categories, a well-designed
and suitably targeted intervention is required
to incentivise specific high value goods such
as biopharmaceuticals, complex generic
drugs, patented drugs or drugs nearing
patent expiry, cell based or gene therapy
drugs. The medical device sector is also an
essential and integral constituent of the
healthcare sector.

3. Govt of India has acknowledged the need

for pharma innovation and made
announcement in the Budget 23-24 that” A
new Programme to promote research and
innovation in pharmaceuticals will be taken
up through Centres of Excellence. We shall
also encourage industry to invest in research
and development in specific priority areas.”

4. Accordingly, Department of
Pharmaceutical has proposed PRIP
(Promotion of Research and Innovation in
Pharma MedTech Sector) scheme with a
budget outlay of Rs. 5000 crores notified
through Gazette notification on 17th August
2023. The objective of the scheme is to
transform Indian pharmaceuticals sector
from cost based to innovation-based growth
by strengthening the research infrastructure
in the country. The aim of the scheme is to
promote industry-academia linkage for R&D
in priority areas and to inculcate the culture
of quality research and nurture our pool of
scientists. This will lead to sustained global
competitive advantage and contribute to
quality employment generation in the
country.

5. The scheme has two components-

Component A: Strengthening the research

infrastructure by establishment of 7 CoEs at
NIPERs-These CoEs would be set up in pre
identified areas with a financial outlay of Rs
700 Crores.

Component B: Promoting research in

pharmaceutical sector by encouraging
research in six priority areas like New
Chemical Entities, Complex generics
including biosimilars, medical devices, stem
cell therapy, orphan drugs, Anti-microbial
resistance etc., wherein financial assistance
will be provided for the Industries, MSME,
SME, Startups working with government
institutes and for both in- house and
academic research. The component has a
financial outlay of Rs.4250 Crores.

Benefits of the scheme-

1. Development of Research Infrastructure-

The scheme would help in building a world
class research atmosphere at NIPERs and
other institutes and help in creating talent
pool of qualified trained students.

2. This scheme will promote industry-

academia linkages by promoting
collaboration between Private sector and
Govt. institutes.

3. Focus on certain priority areas which will

help India’s pharma industry leapfrog and
radically strengthen its position in the world
market as innovation accounts for 2/3rd of
global pharmaceutical opportunities.

4. The scheme would help in launching of

commercially viable products which will
accelerate the growth of Indian
pharmaceutical sector by increased revenue
and creating employment opportunities.
5. The scheme would help in the
development of affordable, accessible
solution for primary area of health concern
thus reducing health care burden.

****

MV

MoCF/National Policy on Research and

Development and Innovation in Pharma-
MedTech Sector in
India/26thSeptember2023

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