Lok Sabha Question No. 1747 (UNSTARRED), answered on 2025-12-10
Subject: Indigenous Manufacturing in Biopharmaceutical Sector
Ministry: SCIENCE AND TECHNOLOGY
Asked by: Shri Bhojraj Nag, Dr. Hemang Joshi

## GOVERNMENT OF INDIA MINISTRY OF SCIENCE & TECHNOLOGY DEPARTMENT OF BIOTECHNOLOGY

## LOK SABHA UNSTARRED QUESTION No.1747

## TO BE ANSWERED ON 10.12.2025

## Indigenous Manufacturing in Biopharmaceutical Sector

Shri Bhojraj Nag:

Dr. Hemang Joshi:

Will the Minister of SCIENCE AND TECHNOLOGY

be pleased to state:

- (a) whether any steps have been taken by the Government to encourage entrepreneurship and indigenous manufacturing in the biopharmaceutical sector;

- (b) if so, the details thereof; and

- (c) the details of the major achievements made by the sector?

## ANSWER MINISTRY OF SCIENCE AND TECHNOLOGY & EARTH SCIENCES

## MINISTER OF STATE (INDEPENDENT CHARGE) FOR THE (DR. JITENDRA SINGH)

- (a) Yes,  the  Government  of  India  has  taken  steps  to  encourage  and  support entrepreneurship and indigenous manufacturing in the biopharmaceutical sector.

## (b) & (c)

1.  Department of Biotechnology (DBT) has set up Biotechnology Industry Research Assistance Council (BIRAC), a not-for-profit Section 8 Public Sector Enterprise, in 2012, as an interface agency to nurture and strengthen the startup ecosystem and encourage entrepreneurship with a focus on healthcare sector that covers Pharma and Biopharma. BIRAC through funding grants has supported startups, SMEs, and innovators. Some of the key achievements of BIRAC include:

##  Funding and supporting early-stage innovation

Launched flagship funding schemes such as BIG (Biotechnology Ignition Grant), SPARSH (Social Innovation Programme for Products: Affordable & Relevant to Societal Health), Equity Schemes like SEED Fund (Sustainable  Entrepreneurship  and  Enterprise  Development)  and  LEAP Fund (Launching Entrepreneurial Driven Affordable Products), to strengthen the startup ecosystem and incentivize private sector R&D by addressing funding gaps post-ideation and pre-commercialization. Nearly 1000 Startups and entrepreneurs have benefitted from BIG scheme and SPARSH has awarded 150+ fellowships, creating 100+ startups and 65+ IPs.

##  Strengthening India's biotech innovation ecosystem

BIRAC  has  established  a  strong  network  of  incubators,  including  94 Incubation  and  pre-incubation  centres,  supporting  3000+  incubates  and fellows, across 25 states and UTs of the country. Opportunities have been provided through BioNEST (Bioincubators Nurturing Entrepreneurship for Scaling  Technologies)  and  E-YUVA  (Empowering Youth for Undertaking Value-Added Innovation Translational Research) schemes.

2.  The Department  of  Biotechnology  (DBT)  is  supporting  the  National  Biopharma Mission (NBM), a Cabinet approved Program entitled Industry-Academia Collaborative Mission for Accelerating Discovery Research to Early Development for Biopharmaceuticals -'Innovate in India ( i3 ) Empowering biotech entrepreneurs  &  accelerating  inclusive  innovation';  being  implemented  through Biotechnology Industry Research Assistance Council (BIRAC). This Program is enhancing  India's  innovation  research  and  product  development  capabilities, especially  by  focusing  on  development  of  vaccines,  biologics  and  medical devices for combating public health concerns.

Some key achievements of NBM include:

-  Under  NBM,  support  has  been  provided  to  over  100  biopharma-oriented projects, involving many MSMEs/startups, and facilitating creation of shared facilities  (testing,  validation,  manufacturing)  -  driving  domestic  capacity  for biologics, vaccines, diagnostics.
-  Product Development - The Mission has successfully delivered 02 COVID-19 vaccines, ZyCoV  D  and  Corbevax,  biosimilar Liraglutide for diabetes, pegylated  interferon  alpha-2b  for  COVID-19,  first    indigenous  MRI  scanner, single-use bioreactors, 09 Covid-19 diagnostic kits, ventilators and reagents,

Laboratory Information Management System, CHO Cell culture media, which have been developed and commercialized.

-  Ecosystem strengthening - NBM has supported setting-up research and GMP manufacturing facilities where over 500 services have been rendered via 18 functional  facilities.    For  the  first  time  in  India  a  network  of  7  Technology Transfers  Offices  (TTOs)  has  been  set  up  to  facilitate  patent  filings  and technology transfers. A  network  of  46  GCP-compliant  clinical  trial  sites  has been set up to facilitate trials for vaccines and therapeutics.
3.  DBT with the approval of the Cabinet, in 2024, is implementing the BioE3 policy towards  fostering  High-performance  Biomanufacturing  in  the  country  impacting the economy, environment and employment.

Under this initiative, Biofoundries and Biomanufacturing hubs are being established  across  the  country  in  all  the  identified  thematic  verticals  of  the Biomanufacturing  program  including  "Precision  biotherapeutics"  for  promoting domestic  manufacturing  of  monoclonal  antibodies,  mRNA  therapies,  cell  and gene therapies and other such advanced precision medicines. The programs are under support.

4.  Department  of  Pharmaceuticals  is  implementing  Production  Linked  Incentive (PLI)  scheme  for  Pharmaceuticals,  which  has  a  total  budgetary  outlay  of  Rs. 15,000 crore, aims to enhance India's manufacturing capabilities by increasing investment and production in the sector and contributing to product diversification to high-value goods in the pharmaceutical sector. Under the scheme, biopharmaceuticals are covered as one of the eligible product categories, where incentive at the rate of 10% on incremental sales is available.

## Achievements:

-  As of September, 2025, 46 biopharmaceutical products including vaccines are being manufactured under the scheme.
-  The cumulative sales (from FY 2022-23 till September 2025) of the eligible biopharmaceuticals  under  the  scheme  is  worth  Rs.  26,832  crore  which includes exports of Rs. 16,290.
5.  Indian  Council  of  Agricultural  Research  (ICAR)  Animal  Science  Institutes  are advancing  entrepreneurship  and  indigenous  biopharmaceutical  manufacturing. ICAR-NIHSAD  (National  Institute  of  High  Security  Animal  Diseases)  develops priority  vaccines  and  diagnostics.  The  ICAR-IVRI  (Indian  Veterinary  Research Institute)  Pashu  Vigyan  Incubator  under  RKVY-RAFTAAR  supports  livestock biopharma startups through ₹5 lakh (Navodaya) and ₹25 lakh (Samriddhi) grants, along with providing R&D infrastructure, mentorship, and regulatory/commercialization assistance.

Some key achievements:

-  Indigenous poultry vaccines and diagnostics now commercially produced, reducing import dependence.
-  Four companies are manufacturing NIHSAD's H9N2 vaccine, enhancing avian influenza preparedness.
-  One industry partner has commercialized the Indirect ELISA kit, enabling affordable nationwide surveillance.
-  Genext  Genomics  Pvt.  Ltd.,  funded  under  RKVY-RAFTAAR,  developing diagnostics for Classical  Swine  Fever  and Brucella and  advancing therapeutic antibodies, cell lines, and biosimilars.

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