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Biopharma SHAKTI Scheme

March 17, 2026 4 min read Science & Technology Economics GS2 GS3
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What Happened

  • The Government has formally launched the Biopharma SHAKTI scheme with a total outlay of ₹10,000 crore over five years, announced initially in Union Budget 2026-27 by Finance Minister Nirmala Sitharaman.
  • SHAKTI stands for BioPharma Strategy for Health Advancement through Knowledge, Technology and Innovation.
  • The scheme targets building a globally competitive domestic biopharmaceutical sector, specifically in biologics and biosimilars used to treat non-communicable diseases such as cancer, diabetes, and autoimmune disorders.
  • Key infrastructure components include establishing 3 new National Institutes of Pharmaceutical Education and Research (NIPERs), upgrading 7 existing ones, and creating a network of over 1,000 accredited clinical trial sites across India.
  • The Central Drugs Standard Control Organisation (CDSCO) is to be strengthened with a dedicated scientific review cadre to meet global regulatory approval timeframes.
  • India aims to capture 5% of the global biopharmaceutical market share through this initiative.

Static Topic Bridges

Biologics and Biosimilars: Definitions and Regulatory Context

Biologics are complex medicines derived from living organisms — including proteins, antibodies, and vaccines — as opposed to conventional small-molecule drugs synthesised chemically. A biosimilar (called "similar biologic" in India's regulatory terminology) is a product shown to be highly similar in quality, safety, and efficacy to an already-approved reference biologic. Because biosimilars are produced by living cells, they are inherently more complex than generic chemical drugs, requiring a separate and rigorous regulatory pathway.

  • In India, biosimilars are regulated under CDSCO guidelines jointly with the Review Committee on Genetic Manipulation (RCGM) under the Department of Biotechnology (DBT).
  • The regulatory framework was introduced in 2012 and revised in 2016; updated draft guidelines aligned with EMA and FDA standards were issued in 2025.
  • Biosimilars offer significantly lower treatment costs than originator biologics, making them critical for affordable healthcare in India.
  • Examples of biosimilar drugs with high market potential: trastuzumab (breast cancer), bevacizumab (various cancers), insulin analogues (diabetes).

Connection to this news: Biopharma SHAKTI directly seeks to expand India's domestic capacity to manufacture biologics and biosimilars, reducing import dependence for high-cost NCDs and positioning India as an export hub.

National Institutes of Pharmaceutical Education and Research (NIPERs)

NIPERs are autonomous institutions established under the NIPER Act, 1998, under the administrative control of the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. They function as apex national-level institutes for higher education, research, and development in pharmaceutical sciences.

  • There are currently 7 NIPERs located at Ahmedabad, Hyderabad, Kolkata, Lucknow, Mohali, Raebareli, and Guwahati.
  • They are autonomous bodies with deemed university status, offering M.S. (Pharm), M.Tech, M.B.A. (Pharm), and Ph.D. programmes.
  • Biopharma SHAKTI will add 3 new NIPERs and upgrade existing ones to include specialised biopharmaceutical research infrastructure.
  • The nodal ministry is the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers.

Connection to this news: Expanding the NIPER network is central to building India's indigenous R&D talent pipeline in biologics — a prerequisite for achieving the 5% global market share target.

India's Pharmaceutical Sector and Export Ambitions

India is known as the "pharmacy of the world," supplying over 20% of global generic medicine exports by volume. However, India's share in the biologics segment — the fastest-growing pharmaceutical category globally — is relatively small compared to its dominance in small-molecule generics. Biologics now represent over 30% of global pharmaceutical sales.

  • India's overall pharma market is valued at approximately $50 billion; biologics remain a fraction of this.
  • The global biopharmaceuticals market is projected to exceed $700 billion by 2030.
  • India already has some biosimilar export capabilities (e.g., Biocon, Dr. Reddy's), but fragmented manufacturing infrastructure limits scale.
  • The scheme's clinical trial network (1,000+ sites) addresses a long-standing bottleneck: India's clinical trial ecosystem contracted sharply after 2013 regulatory changes and needs rebuilding.

Connection to this news: Biopharma SHAKTI is a structural intervention to move India up the pharmaceutical value chain from generics to complex biologics, targeting both domestic affordability and export competitiveness.

Central Drugs Standard Control Organisation (CDSCO)

CDSCO is India's national regulatory authority for pharmaceuticals and medical devices, functioning under the Ministry of Health and Family Welfare. It is analogous to the US FDA and the European EMA. It grants market authorisation, regulates clinical trials, and enforces quality standards across the drug supply chain.

  • CDSCO is headed by the Drugs Controller General of India (DCGI).
  • It operates under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017.
  • India's drug approval timelines have historically lagged behind global regulators, which delays domestic availability of new biologics.
  • The scheme's mandate to strengthen CDSCO with a dedicated scientific cadre aims to align India's approval timelines with the FDA and EMA, attracting global clinical trials and investments.

Connection to this news: A strengthened CDSCO is essential for Biopharma SHAKTI's goal of integrating India into global biopharmaceutical supply chains and attracting international R&D partnerships.

Key Facts & Data

  • Scheme outlay: ₹10,000 crore over 5 years
  • Full form: BioPharma Strategy for Health Advancement through Knowledge, Technology and Innovation
  • Nodal ministry: Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers
  • New NIPERs: 3 new + 7 upgraded existing
  • Clinical trial sites: 1,000+ accredited sites to be created
  • Target diseases: Cancer, diabetes, autoimmune disorders (via biologics/biosimilars)
  • Global market target: 5% of global biopharmaceutical market
  • India imports significant volumes of high-cost biologics — this scheme aims to reverse that trend
  • Announced in Union Budget 2026-27 on February 1, 2026