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Implementation of Biopharma SHAKTI

March 20, 2026 5 min read Science & Technology Economics GS Paper 3 (Science & Technology Economy/Industrial Policy)
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What Happened

  • The government has announced implementation details for the Biopharma SHAKTI scheme, first proposed in Union Budget 2026–27, with a total outlay of ₹10,000 crore over five years.
  • SHAKTI stands for Strategy for Healthcare Advancement through Knowledge, Technology, and Innovation.
  • The scheme aims to build a globally competitive domestic ecosystem for biologics and biosimilars, targeting a 5% share of the global biopharmaceutical market.
  • Key components include: establishment of 3 new National Institutes of Pharmaceutical Education and Research (NIPERs) and upgrading 7 existing ones; creation of a network of over 1,000 accredited clinical trial sites across India; and strengthening the Central Drugs Standard Control Organisation (CDSCO) with a dedicated scientific review cadre.
  • The scheme targets non-communicable diseases (NCDs) such as cancer, diabetes, and autoimmune disorders through domestic production of high-value biologics and biosimilars, reducing import dependence.
  • India currently has over 135 approved biosimilars domestically and is already the world's largest supplier of generic medicines; SHAKTI aims to replicate this generics success in the biologics space.

Static Topic Bridges

Biologics and Biosimilars — Science and Market

Biologics are large, complex molecules derived from living cells (bacteria, yeast, mammalian cells) rather than chemical synthesis. They include monoclonal antibodies, vaccines, recombinant proteins, and gene therapies. Biosimilars are approved copies of reference biologic drugs whose patents have expired, demonstrated to be highly similar in structure, efficacy, and safety.

  • Biologics are the fastest-growing segment of the global pharmaceutical market (estimated $500 billion by 2030), driven by treatments for cancer, rheumatoid arthritis, diabetes (insulin analogues), and rare genetic disorders.
  • Unlike small-molecule generics (identical copies), biosimilars require extensive clinical testing to demonstrate similarity because slight differences in manufacturing can affect therapeutic outcomes — hence their approval pathway is more rigorous and expensive than standard generic drugs.
  • India's biosimilars market is projected to grow from $184 million in 2026 to $1.02 billion by 2035 (CAGR ~21%), driven by patent expirations of major biologics and government incentives.
  • Monoclonal antibodies (mAbs) account for ~55% of India's biosimilars market; major products include trastuzumab (breast cancer), bevacizumab (colorectal cancer), adalimumab (autoimmune), and rituximab (lymphoma).
  • Indian companies with significant biologics capability include Biocon, Dr. Reddy's, Zydus, Reliance Life Sciences, and Intas Biologicals.

Connection to this news: Biopharma SHAKTI is designed to accelerate India's transition from small-molecule generic dominance to leadership in biologics and biosimilars — a strategically important shift given global patent expiries and growing NCD burden.

CDSCO and India's Pharmaceutical Regulatory Framework

The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority for pharmaceuticals, medical devices, and clinical trials. It functions under the Ministry of Health and Family Welfare. The Drug Controller General of India (DCGI) heads CDSCO.

  • Regulatory basis: Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945; New Drugs and Clinical Trials Rules, 2019.
  • Biosimilar regulation: CDSCO and the Department of Biotechnology (DBT) jointly released the "Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India" in 2016, providing the approval pathway for biosimilars.
  • Approval pathway includes physicochemical characterisation, preclinical studies, comparative clinical trials, and post-marketing pharmacovigilance.
  • CDSCO faces a longstanding criticism of understaffing and slow review timelines compared to the US FDA (PDUFA timelines: 10–12 months) or EMA.
  • Biopharma SHAKTI's commitment to strengthen CDSCO with a "dedicated scientific review cadre" directly addresses this regulatory capacity bottleneck.
  • India also launched the PLI scheme for pharmaceuticals (₹15,000 crore) covering biologics as a priority segment, complementing SHAKTI.

Connection to this news: A stronger, faster CDSCO is a prerequisite for the Biopharma SHAKTI ambition — global companies need regulatory predictability to partner with Indian firms on clinical trials and biosimilar development.

India's Pharmaceutical Industry — Policy Context

India is the world's largest supplier of generic medicines by volume, supplying ~20% of global generic exports. The pharmaceutical sector contributes ~$25 billion in annual exports. Biopharma SHAKTI is the most significant policy intervention specifically targeting the high-value biologics segment.

  • India's pharma sector context: "Pharmacy of the World" tag earned through small-molecule generics; ~3,000 pharma companies, 10,500 manufacturing units.
  • PLI Scheme for Pharmaceuticals (₹15,000 crore): Covers 41 products in 3 categories including biopharmaceuticals, complex generics, and patented drugs nearing expiry.
  • NIPERs (National Institutes of Pharmaceutical Education and Research): Autonomous institutes under the Department of Pharmaceuticals; 9 currently exist across India (Ahmedabad, Hyderabad, Kolkata, Lucknow, etc.). SHAKTI will add 3 more and upgrade 7 existing ones.
  • Clinical trials: India has long been underutilised as a clinical trials hub due to regulatory uncertainty and infrastructure gaps; the target of 1,000+ accredited sites aims to make India a top-3 global clinical trial destination.
  • INDIABiosimilars initiative: Part of the National Biopharma Mission (₹1,500 crore), an umbrella programme co-funded by the World Bank, of which SHAKTI is the scaled-up successor.

Connection to this news: By combining R&D infrastructure (NIPERs), regulatory strengthening (CDSCO cadre), clinical trial infrastructure, and financial incentives, Biopharma SHAKTI takes a full-ecosystem approach rather than a single-intervention strategy — the lesson learned from why the generic medicine success took two decades to build.

Key Facts & Data

  • Scheme name: Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology, and Innovation)
  • Outlay: ₹10,000 crore over 5 years
  • Announced in: Union Budget 2026–27
  • Target: 5% share of the global biopharmaceutical market
  • New NIPERs: 3 new establishments + 7 existing upgraded
  • Clinical trial sites: Network of 1,000+ accredited sites to be created
  • Regulatory reform: Dedicated scientific review cadre for CDSCO
  • India's current biosimilars portfolio: 135+ approved
  • Biosimilars market growth: $184 million (2026) → $1.02 billion by 2035 (CAGR ~21%)
  • Complementary scheme: PLI for Pharmaceuticals (₹15,000 crore)
  • Regulatory authority: CDSCO under Drug Controller General of India (DCGI); Ministry of Health & Family Welfare
  • Focus diseases: Cancer, diabetes, autoimmune disorders (NCDs)