Why in the News

India is the 3rd largest pharmaceutical producer by volume and 14th by value, yet remains heavily dependent on imports for high-value biologic medicines. Biologics dominate modern treatment for cancer, diabetes, rheumatoid arthritis, and infectious diseases, while biosimilars offer cost-effective alternatives. The Union Budget 2026-27 announced Biopharma SHAKTI, a ₹10,000-crore initiative over five years to strengthen domestic production of biologics and biosimilars. This is the first dedicated national framework for biopharma, contrasting with earlier schemes that treated biologics as sub-components of biotechnology or pharma policy. The announcement is significant as biologics now account for a major share of therapies for cancer, diabetes, autoimmune disorders, and vaccines, while India aims to capture 5% of the global biopharmaceutical market.

What Is Biopharma and Why Does It Matter?

1. Biopharma, or biopharmaceuticals, refers to the part of the pharmaceutical industry that focuses on developing and manufacturing medicines using living biological systems, rather than relying solely on chemical synthesis.
2. Biopharma medicines are produced by working with cells, microorganisms or other biological materials. These may include human or animal cells, bacteria, fungi or similar biological platforms that are used to grow or produce therapeutic substances
3. Biopharmaceuticals: Medicines produced using living biological systems such as human or animal cells, bacteria, fungi, or microbes rather than chemical synthesis.
4. Product categories: Include vaccines, therapeutic proteins, monoclonal antibodies, gene and cell therapies, modern insulin, and recombinant protein drugs.
5. Biosimilars: Near-identical versions of approved biologic medicines that offer affordable alternatives once patent protection expires
6. Biologics: They are complex medicines derived from living cells, while biosimilars are highly similar, equally safe, and effective, lower-cost alternatives to already approved biologics.
   1. While biologics are the original, brand-name, and often more expensive drugs, biosimilars are approved after the original patent expires, offering similar, high-quality, and, on average, 15%-35% cheaper, therapeutic options for diseases like cancer and arthritis.

What is Biopharma SHAKTI?

1. It is a dedicated national initiative with an outlay of Rs. 10,000 crores over five years, aimed at strengthening India’s end-to-end ecosystem for biologics and biosimilars.
2. Aim: It is designed to:
   1. support domestic development and manufacturing of high-value biopharmaceutical products and medicines
   2. reduce import dependence
   3. enhance India’s competitiveness in global biologics supply chains.
3. Institutional expansion: Expansion and strengthening of the Biopharma-focused network through the establishment of three new National Institutes of Pharmaceutical Education and Research (NIPERs) and the upgradation of seven existing NIPERs
4. Creation of a large-scale clinical research ecosystem, with a proposal to develop over 1,000 accredited clinical trial sites across the country.

How Is Clinical Research Capacity Being Strengthened?

1. Trial infrastructure: Proposes 1,000+ accredited clinical trial sites nationwide.
2. Advanced trials: Enhances capacity for complex biologics and biosimilar trials.
3. Global credibility: Positions India as a preferred destination for ethical and efficient clinical research.

What Regulatory Reforms Are Emphasised?

1. Institutional strengthening: Enhances capacity of the Central Drugs Standard Control Organisation (CDSCO).
2. Technical expertise: Induction of specialised scientific personnel for biologics evaluation.
3. Global alignment: Synchronises approval timelines with international regulatory standards.

What Is the Role of the National Biopharma Mission (NBM)?

1. Budgetary linkage: Biopharma SHAKTI builds upon the National Biopharma Mission (NBM) launched in 2017.
2. Mission objective: Transform India into a $100 billion biotech industry and capture 5% global share.
3. Financial scale: ₹1,500 crore, co-funded by the World Bank.
4. Implementing agency: Biotechnology Industry Research Assistance Council (BIRAC) under DBT.

How Do Other Government Schemes Support Biopharma?

1. BIRAC-led Innovation Support
   1. Infrastructure: 95 bio-incubation centres.
   2. Funding: BIG, SEED, LEAP funds for early-to-commercial stage innovation.
   3. Outcome: Nearly 1,000 innovators supported.
2. Manufacturing Support Schemes
   1. PLI for Pharmaceuticals: Enhances domestic manufacturing capacity.
   2. Bulk Drug Parks Scheme: Reduces import dependence for APIs.
   3. SPI Scheme: Upgrades MSMEs to WHO-GMP standards.
3. PRIP Scheme (2023)
   1. Focus: Biosimilars, complex generics, precision medicine, MedTech innovation.
4. BioE3 Policy and Bio-RIDE Scheme
   1. Objective: Promote biomanufacturing, biofoundries, and bio-AI hubs.
   2. Sectors: Precision biotherapeutics, climate resilience, biobased chemicals.

Conclusion

Biopharma SHAKTI represents a consolidation of India’s decade-long investments in biotechnology, innovation, and pharmaceutical manufacturing. By prioritising biologics and biosimilars, the initiative addresses emerging disease patterns, strengthens regulatory credibility, and positions India for higher value capture in the global pharmaceutical economy.

PYQ Relevance

[UPSC 2021] What are the research and developmental achievements in applied biotechnology? How will these achievements help to uplift the poorer sections of society?

Linkage: Biotechnology and applied life sciences are repeatedly tested areas in GS-III, especially in the context of public health, indigenous innovation, manufacturing, and affordability of medicines. Recent UPSC trends show a clear shift from static biotech definitions to policy-driven questions linking science, economy, and governance.

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