Why in news?
Finance Minister Nirmala Sitharaman announced the Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology and Innovation) scheme in the Union Budget 2026‑27. With an outlay of ₹10,000 crores over five years, the programme seeks to make India a global hub for manufacturing biologics and biosimilars.
Background
India’s biopharmaceutical sector has grown rapidly, supplying affordable vaccines and generic medicines worldwide. However, domestic capability in complex biologics—medicines derived from living cells—and biosimilars (near‑identical versions of biologics) remains limited. Meanwhile, the burden of non‑communicable diseases such as diabetes, cancer and autoimmune disorders is rising, necessitating greater access to these therapies. Geopolitical uncertainties, such as proposed U.S. tariffs on patented drugs, further underline the need for self‑sufficiency.
Key components of Biopharma SHAKTI
- Infrastructure expansion: The scheme will establish three new National Institutes of Pharmaceutical Education and Research (NIPER) and upgrade seven existing ones to build specialised human capital.
- Clinical trial network: A nationwide network of over 1,000 accredited clinical trial sites will be created, improving the capacity and quality of clinical research in India.
- Regulatory strengthening: The Central Drugs Standard Control Organisation (CDSCO) will be equipped with scientific committees and specialised cadres to reduce approval timelines and meet global standards.
- Support for biologics and biosimilars: The programme will fund research, scale‑up manufacturing, and promote innovation for biologics used in treating cancers, autoimmune diseases and genetic disorders.
Significance
- Helps India move beyond generics into high‑value biologics, enhancing resilience against external trade shocks and price controls.
- Strengthens the clinical trials ecosystem, making India more attractive for global research collaborations and faster introduction of new therapies.
- Supports public health goals by ensuring availability of affordable biologics for non‑communicable diseases, which account for a significant share of mortality.
Source: PIB
