Biopharma SHAKTI (2026): Strengthening India’s Biopharmaceutical Manufacturing

Policy Update
Tanisha Hooda

Background

Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology and Innovation) was proposed in the Union Budget 2026–27 to develop India as a global biopharma manufacturing hub. The initiative has an outlay of ₹10,000 crore over the next five years and aims to build an ecosystem for the domestic production of biologics and biosimilars (Government of India, 2026a). The initiative was announced as part of the Union Government’s broader focus on the healthcare sector under the three Kartavyas outlined in the Union Budget 2026–27: accelerating and sustaining economic growth, fulfilling aspirations and building the capacity of the population, and ensuring access to resources for every family, community, region and sector. Health was identified as an important component of all three priorities.

The Budget announcement also included measures to strengthen the healthcare workforce and related institutional capacity. Existing institutions for Allied Health Professionals (AHPs) will be upgraded, while new AHP institutions will be established in the government and private sectors across 10 selected disciplines, including optometry, radiology, anaesthesia, OT Technology, Applied Psychology and Behavioural Health. These interventions aim to add 100,000 AHPs over the next five years.

The broader healthcare measures announced alongside Biopharma SHAKTI also include the development of a strong care ecosystem for geriatric and allied care services, with 1.5 lakh caregivers to be trained in the coming year. The Union Budget also proposed a scheme to support States in establishing five Regional Medical Hubs in partnership with the private sector, along with measures to strengthen traditional medicine, mental healthcare and emergency and trauma care. Together, these measures reflect the Union Government’s emphasis on expanding healthcare capacity, developing skilled human resources and strengthening India’s healthcare ecosystem.

Functioning

1. Strengthening Biopharma Research and Development: Biopharma SHAKTI will strengthen research and development in the biopharmaceutical sector through a Biopharma Discovery Grant Fund, Discovery & Development Equity Fund, a Biopharma-focused NIPER Network and a National Biopharma R&D Network. These mechanisms are intended to support the development of new biologics and biosimilars and encourage collaboration among academic institutions, research organisations and industry. By strengthening domestic research capabilities, the scheme aims to promote innovation and build the capacity needed for India to develop and manufacture advanced biopharmaceutical products domestically.

2. Expanding Clinical Trials and Strengthening Drug Regulation: The scheme proposes a nationally accredited network of 1,000 clinical trial sites under the Indian Council of Medical Research (ICMR) to expand and strengthen India’s clinical research infrastructure. This would provide a nationally accredited network for conducting clinical trials and help increase India’s clinical research capacity. At the same time, CDSCO will be strengthened through a dedicated Scientific Review Cadre and specialist positions in advanced areas such as gene therapy. These measures aim to strengthen India’s regulatory capacity, enable faster and globally credible drug approvals, and support the development of innovative biopharmaceutical products.

3. Scaling Biopharmaceutical Manufacturing Capacity: A key function of Biopharma SHAKTI is to scale up India’s biopharmaceutical manufacturing capacity. The programme focuses on moving beyond the traditional emphasis on generic medicines towards biosimilars, biologics and advanced therapeutics. Biologics are medicines produced using living cells or biological processes, while biosimilars are highly similar versions of already approved biologic medicines. By strengthening domestic manufacturing capabilities in these areas, the programme aims to enhance India’s competitiveness in the global biologics market and improve access to advanced therapies at affordable costs.

4. Strengthening Supply Chain Resilience: Biopharma SHAKTI seeks to strengthen the resilience of India’s biopharmaceutical ecosystem by addressing vulnerabilities across the pharmaceutical supply chain. Greater supply-chain resilience can support the reliable availability of critical inputs and biopharmaceutical products and reduce dependence on external sources. This would contribute to a more secure and sustainable domestic biopharmaceutical ecosystem.

5. Developing Advanced Biopharmaceutical Capabilities and Enhancing Global Competitiveness: The initiative seeks to strengthen India’s capabilities in high-value and emerging areas of biopharmaceutical development by promoting advanced technologies, innovation, and specialised production. These efforts can enable Indian companies and research institutions to participate more effectively in high-value segments of the global biopharmaceutical value chain, supporting India’s transition from primarily being a supplier of affordable medicines to becoming a stronger global player in advanced and technology-intensive biopharmaceutical products.

Performance

1. Growth of India’s Bioeconomy: India’s Bioeconomy has witnessed significant growth in recent years, reflecting the expanding role of biotechnology in India’s economic and industrial development. The Bioeconomy crossed the US$150 billion mark in 2023 and reached US$165.7 billion in 2024, registering 9.7% growth during the year. This growth provides a strong foundation for strengthening India’s biopharmaceutical ecosystem through Biopharma SHAKTI.

Figure 1: Growth of India’s Bioeconomy, 2020–2024 (US$ Billion)

Source: BIRAC (2026), BIRAC Impact Report 2026, p. 92.

The graph indicates a strong and consistent expansion of India’s BioEconomy between 2020 and 2024. It increased from US$86.0 billion in 2020 to US$165.7 billion in 2024, showing that the sector nearly doubled in size over the period. The growth was particularly notable between 2021 and 2022, after which the BioEconomy continued to expand steadily. Overall, the trend highlights the growing economic importance of India’s biotechnology sector and provides a strong foundation for initiatives such as Biopharma SHAKTI.

2. Growth of India’s BioPharma Segment, 2024–2025: India’s BioPharma sector has emerged as a major component of the country’s growing BioEconomy. During 2024–2025, the segment continued to expand, supported by growth in therapeutic manufacturing, export activity and biologics capacity. This indicates the strengthening of India’s capabilities in biopharmaceutical production and its increasing role in the global life-sciences value chain.

Figure 2: Growth of India’s BioPharma Segment, 2024–2025 (US$ Billion)

Source: ABLE (2026), India BioEconomy Report 2026.

The figure shows a clear increase in the value of India’s BioPharma segment between 2024 and 2025. The segment grew from US$58.4 billion in 2024 to US$64.5 billion in 2025, representing an increase of US$6.1 billion, or approximately 10.4%. This growth reflects continued expansion in therapeutic manufacturing, export activity, and biologics capacity, highlighting the strengthening of India’s biopharmaceutical sector

3. National Biopharma Mission — Programme Outcomes: The National Biopharma Mission (NBM) is a pan-India industry–academia collaborative programme implemented by BIRAC to strengthen India’s capabilities in biopharmaceutical research and product development. It focuses on vaccines, biologics, medical devices and diagnostics, while supporting researchers, start-ups, SMEs and industry in developing affordable healthcare solutions.

Programme Indicator	Details
Total Mission Cost	US$ 250 million
World Bank Co-financing	50%
Coverage	Pan-India
Implementation Agency	BIRAC
Key Focus Areas	Vaccines, Biologics, Medical Devices & Diagnostics
Target Groups	Researchers, Start-ups, SMEs & Industry

Source: BIRAC, National Biopharma Mission.

The Mission provides a collaborative framework for translating scientific research into market-oriented biopharmaceutical solutions. Its emphasis on early-stage development helps reduce technological and financial risks and strengthens linkages between academia, entrepreneurs and industry.

4. Pharmaceutical Export Performance: India’s pharmaceutical exports have continued to expand, reflecting the sector’s strong global competitiveness and resilience. Pharmaceutical exports increased from US$30.38 billion in FY2024–25 to US$31.11 billion in FY2025–26 .

Figure 3: India’s Pharmaceutical Exports, FY2024–25 to FY2025–26

Source: IBEF, 2026, Indian Pharmaceutical Industry, India Brand Equity Foundation.

The figure shows that India’s pharmaceutical exports increased from US$30.38 billion in FY2024–25 to US$31.11 billion in FY2025–26. This indicates a 2.4% year-on-year increase, reflecting continued growth in India’s global pharmaceutical trade despite external market challenges. The rise also highlights India’s strong position as a major supplier of medicines and pharmaceutical products to international markets.

5. Growth of India’s Domestic Pharmaceutical Market: India’s domestic pharmaceutical market has also expanded significantly and is expected to witness further growth. The market was valued at approximately US$60 billion in FY2025–26 and is projected to reach US$130 billion by 2030.

Figure 4: India’s Domestic Pharmaceutical Market — FY2025–26 and 2030 Projection

Source: IBEF, 2026, Indian Pharmaceutical Industry, India Brand Equity Foundation.

The figure shows the projected growth of India’s domestic pharmaceutical market from US$60 billion in FY2026 to US$130 billion by 2030. The market is expected to more than double during this period, indicating strong growth potential in India’s pharmaceutical sector. This expansion is supported by rising domestic demand, strong manufacturing capabilities, policy support, and India’s position as a major producer of generic medicines and vaccines.

Impact

1. Reduced Import Dependence and Stronger Domestic Manufacturing: Biopharma SHAKTI is expected to strengthen India’s capacity to manufacture biologics and biosimilars domestically. At present, high-value and technologically complex biopharmaceutical products can involve dependence on global supply chains. By supporting domestic development and manufacturing, the initiative can reduce import dependence and improve the resilience of India’s biopharmaceutical supply chain. This would also strengthen India’s ability to produce advanced therapies within the country.

2. India’s Greater Participation in the Global Biopharma Value Chain: The initiative can help India move beyond its traditional role as a major producer of affordable generic medicines towards higher-value biopharmaceutical products. The Government has set an ambition of capturing 5% of the global biopharmaceutical market share (Government of India, 2026a). Achieving this would increase India’s participation in global biopharma value chains and strengthen its position as a destination for biopharmaceutical manufacturing, innovation and investment.

3. Expansion of Clinical Research and Faster Product Development: The proposed establishment of over 1,000 accredited clinical trial sites can substantially expand India’s clinical research infrastructure. A larger and nationally accredited network would improve the country’s ability to conduct trials for complex biologics and biosimilars. This can help reduce bottlenecks in product development, support evidence-based regulatory approvals and make India more attractive for global clinical research and biopharmaceutical innovation.

4. Stronger Regulatory Capacity and Global Credibility: The strengthening of CDSCO through specialised scientific and technical personnel can improve India’s capacity to evaluate complex biopharmaceutical products. Greater regulatory expertise can support more efficient assessment and approval processes while maintaining safety and quality standards. Over time, stronger regulatory capacity can enhance international confidence in Indian biopharmaceutical products and facilitate their acceptance in global markets.

5. Development of Skilled Human Capital and a Stronger Innovation Ecosystem: Biopharma SHAKTI’s focus on expanding the NIPER network and strengthening research and industry linkages can address the growing demand for specialised skills in biopharma R&D, manufacturing and regulation. This can create a stronger pool of scientists, researchers and technical professionals while encouraging collaboration between academia, start-ups and industry. In the longer term, such human-capital and innovation capacity can support the development of more high-value biopharmaceutical products within India.

Emerging Issues

1. Need for Specialised Biopharma Human Resources: The expansion of biopharma research, manufacturing and regulation requires a highly specialised workforce of scientists, researchers and technical professionals. The proposed establishment of three new NIPERs and upgradation of seven existing institutions indicates the growing need for specialised human resources in the sector. To address this gap, the Government and NIPERs should strengthen specialised biopharma programmes, industry-linked training and practical research, while industry can provide internships, apprenticeships and skill-development opportunities.

2. Limited Clinical Research Capacity and Infrastructure: The development of a large-scale clinical research ecosystem is essential for the successful development and commercialisation of biologics and biosimilars. However, advanced clinical trials require accredited facilities, trained investigators, adequate patient databases and effective ethical and monitoring mechanisms. The Government, ICMR and research institutions should therefore expand accredited trial infrastructure and investigator training, while greater collaboration between academia and industry can strengthen clinical research networks and improve the efficiency of trials.

3. Regulatory Capacity for Complex Biopharmaceutical Products: Biologics and biosimilars involve complex scientific and manufacturing processes and therefore require specialised regulatory expertise. The proposed creation of a dedicated Scientific Review Cadre under CDSCO highlights the need to strengthen regulatory capacity. To ensure faster and globally credible approvals, CDSCO should expand specialised scientific expertise and digital regulatory systems, while pharmaceutical companies should improve the quality and completeness of regulatory submissions.

4. Financing and Commercialisation Challenges for Start-ups: Biopharmaceutical innovation involves substantial investment and long development timelines, particularly during clinical trials, regulatory approval, technology validation and manufacturing scale-up. Although Biopharma SHAKTI proposes early-stage innovation funding and structured equity support, start-ups may still face difficulties in accessing follow-on finance. Government and BIRAC can address this by providing milestone-based funding and facilitating access to additional investment, while stronger partnerships between start-ups, venture capital firms and established pharmaceutical companies can support commercialisation.

5. Challenges in Building Competitive Domestic Manufacturing and Supply Chains: Developing a globally competitive biopharmaceutical manufacturing ecosystem requires reliable access to advanced technologies, specialised inputs, quality infrastructure and efficient supply chains. Continued dependence on external sources for critical inputs or technologies could constrain the objective of reducing import dependence. The Government should therefore support domestic manufacturing infrastructure and critical inputs, while industry should invest in indigenous technologies, local sourcing and quality systems, with research institutions contributing to the development of domestic production technologies.

Way Forward

Biopharma SHAKTI should be implemented through a clear and time-bound framework with measurable targets for research, clinical trials, manufacturing and regulatory approvals. The Government should establish transparent monitoring mechanisms to track progress against these targets and ensure effective coordination among the Department of Pharmaceuticals, DBT, BIRAC, CDSCO, ICMR and other relevant institutions. Greater integration between existing initiatives such as the National Biopharma Mission, Promotion of Research and Innovation (PRIP) and Biotechnology Research Innovation and Entrepreneurship Development (Bio-RIDE) and Biopharma SHAKTI can also help avoid duplication and ensure that public investments generate stronger outcomes across the entire biopharmaceutical value chain.

Greater emphasis should be placed on building specialised human capital and strengthening research-to-market linkages. NIPERs, universities, research institutions and industry should collaborate on specialised training, joint research programmes, internships and technology-transfer mechanisms. At the same time, start-ups should be provided with easier access to milestone-based funding, incubation facilities and follow-on investment so that promising discoveries can move beyond the laboratory towards clinical development and commercialisation. This would strengthen India’s innovation ecosystem and improve the translation of scientific research into affordable biopharmaceutical products.

India should also focus on building a resilient and globally competitive manufacturing ecosystem for biologics and biosimilars. This requires investment in advanced manufacturing technologies, domestic production of critical inputs, quality infrastructure and internationally aligned regulatory standards. Stronger partnerships between government, pharmaceutical companies, start-ups and research institutions can support technology development, local sourcing and scale-up of production. Alongside strengthening domestic capabilities, India should pursue greater international collaboration and market access so that Indian biopharmaceutical products can meet global quality requirements and expand the country’s presence in high-value segments of the global biopharma market.

References

Press Information Bureau (PIB). (2026). Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology and Innovation) Proposed in the Union Budget 2026–27. Government of India, 1 February 2026.
https://www.pib.gov.in/PressReleasePage.aspx?PRID=2221443&reg=48&lang=2

Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. (2026). Biopharma SHAKTI Scheme. Government of India, 17 March 2026.
https://www.pib.gov.in/PressReleasePage.aspx?PRID=2241168&reg=3&lang=1

India Brand Equity Foundation (IBEF). (2026). Biopharmaceuticals are Shaping the Future of Modern Healthcare, India Well-Positioned to Emerge as a Global Leader. India Brand Equity Foundation, 12 June 2026.
https://www.ibef.org/news/biopharmaceuticals-are-shaping-the-future-of-modern-healthcare-india-well-positioned-to-emerge-as-a-global-leader

Biotechnology Industry Research Assistance Council (BIRAC). (2026). BIRAC Impact Report 2026. Biotechnology Industry Research Assistance Council, Department of Biotechnology, Ministry of Science & Technology, Government of India.
https://www.birac.nic.in/webcontent/BIRAC_Impact_Report_2026.pdf

Association of Biotechnology Led Enterprises (ABLE). (2026). India BioEconomy Report 2026. Prepared for the Make in India Facilitation Cell for Biotechnology, Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology, Government of India.
https://ableindia.in/manage/images/resourceuploads/_IBER%202026_compressed.pdf

Biotechnology Industry Research Assistance Council (BIRAC). (n.d.). National Biopharma Mission. Department of Biotechnology, Ministry of Science & Technology, Government of India.
https://www.birac.nic.in/desc_new.php?id=738

India Brand Equity Foundation (IBEF). (2026). Indian Pharmaceutical Industry. Pharmaceuticals Industry Report.
https://www.ibef.org/industry/pharmaceutical-india

Press Information Bureau (PIB). (2026). Transforming India into a Global Biopharma Hub. Budget 2026–27 Series, Government of India, 2 February 2026.
https://www.pib.gov.in/PressReleasePage.aspx?PRID=2222079&reg=48&lang=2

Press Information Bureau (PIB). (2026). Bio Pharma SHAKTI Scheme. Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, Government of India, 10 March 2026.
https://www.pib.gov.in/PressReleasePage.aspx?PRID=2237416&reg=48&lang=2

About the Contributor:

Tanisha Hooda is a Research Intern at the Impact and Policy Research Institute (IMPRI) and a B.A. (Hons.) Economics graduate from Manav Rachna International Institute of Research and Studies (MRIIRS), Faridabad. Her research interests include competition policy, digital economy, public policy, and economic development, with a focus on analysing the socio-economic implications of emerging policy frameworks.

Acknowledgement:

The author extends sincere gratitude to the reviewers, Tanisha and Karnavi, and the IMPRI India team for their valuable guidance, support, and review of this Policy Update.