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Biopharma SHAKTI Scheme
Overview:
The Union Budget envisions the Biopharma SHAKTI scheme with an outlay of Rs. 10,000 crores over the next 5 years. The scheme provides for building an ecosystem for domestic production of biologics and scaling up biosimilar production, along with infrastructure, clinical research capacity, and regulatory strengthening.
Biopharma SHAKTI Scheme (Strategy for Healthcare Advancement through Knowledge, Technology and Innovation):
| Dimension | Key Details |
|---|---|
| Full Form | Strategy for Healthcare Advancement through Knowledge, Technology and Innovation |
| Purpose | Making India a global manufacturing hub for biopharma |
| Objectives | Building the ecosystem for domestic production of biologics; provides for scaling up production of biosimilar medications |
| Definition | Complex medicines derived from living organisms (cells, bacteria, or animals) or their components, such as proteins and genes |
| Biological Medications | Used to treat severe conditions including cancers, autoimmune diseases (arthritis, IBD, psoriasis), and genetic disorders |
| Manufacturing Characteristics | Mandates focus on medicines that tend to be complicated to purify, process and manufacture |
| Biosimilars | Highly similar but not identical versions of biological drugs |
| Period | Applies for 5 years |
| Infrastructural Support | Launching 3 new National Institutes of Pharmaceutical Education and Research (NIPER); provides for upgrading 7 existing institutes as part of a Biopharma-focused network |
| Clinical Research | Creating a network of over 1,000 accredited sites for clinical trials in India |
| Regulatory Strengthening | Strengthening the Central Drugs Standard Control Organisation to meet global standards and approval timeframes through a dedicated scientific review cadre and specialists |
| Disease Statistics | NCDs are responsible for 63% of all deaths in India; cardiovascular diseases comprise 27% of overall mortality, followed by chronic respiratory diseases (11%), cancers (9%), and diabetes (3%) |
| Pharmaceutical Sector Turnover | In FY25, annual turnover reaches Rs. 4.72 lakh crore; exports grow at a CAGR of 7% over FY15 to FY25 |
| Medical Devices Exports | Exports to 187 countries in FY25; exported items comprise high-end equipment including MRI and CT scanners, linear accelerators, cardiac stents, and ventilators |