Source: The Economic Times
Context:
The Union Budget 2026–27, presented by Nirmala Sitharaman, announced a ₹10,000 crore allocation for the Biopharma SHAKTI Initiative, signalling a major policy push to transform India into a global biopharmaceutical manufacturing and innovation hub.
The initiative addresses:
- Rising burden of non-communicable diseases (NCDs)
- Heavy import dependence for high-value biologic drugs
- Need for innovation-led growth beyond generic medicines
What is Biopharma SHAKTI?
Biopharma SHAKTI stands for Strategy for Healthcare Advancement through Knowledge, Technology, and Innovation.
It is a flagship, multi-year initiative aimed at:
- Strengthening India’s biopharmaceutical ecosystem
- Scaling domestic production of biologics and biosimilars
- Enhancing research, clinical trials, and regulatory capacity
- Integrating biotechnology with manufacturing, healthcare, and exports
Key Features of the Biopharma SHAKTI Initiative
1. Financial Outlay and Time Horizon
- Outlay: ₹10,000 crore
- Duration: 5 years
- Focus on long-gestation, high-impact capacity building, rather than short-term subsidies
2. Disease Focus and Strategic Rationale
Target Areas
- Cancer
- Diabetes
- Autoimmune disorders
- Other lifestyle-related NCDs
Why Biologics & Biosimilars?
- Biologics account for a large and growing share of global drug spending
- India currently dominates small-molecule generics, but lags in:
- Biologic innovation
- Complex manufacturing
- Biosimilars offer:
- Affordable alternatives
- Export opportunities
- Health security
3. Institutional & Research Infrastructure
National Institutes of Pharmaceutical Education and Research (NIPERs)
- 3 new NIPERs to be established
- 7 existing NIPERs to be upgraded
Role of NIPERs
- Advanced training in:
- Bioprocess engineering
- Regulatory sciences
- Clinical research
- Industry-academia collaboration
- Talent pipeline for biopharma manufacturing
Clinical Trials Ecosystem
- Creation of a network of 1,000+ accredited India Clinical Trials sites
Regulatory Strengthening
- Strengthening Central Drugs Standard Control Organisation (CDSCO)
- Introduction of a dedicated scientific review cadre
- Aim: Match global approval timeframes
Addresses one of India’s biggest bottlenecks—regulatory delays.
4. Bio-Manufacturing and Allied Ecosystem Support
Chemical & Pharma Hubs
- Establishment of 3 Chemical Parks
- Cluster-based, plug-and-play model
Benefits
- Reduces import dependence on intermediates
- Ensures environmental compliance
- Lowers cost of biopharma inputs
- Strengthens life-sciences value chains
Agricultural Biotechnology Linkage
- Launch of Bharat-VISTAAR
- A multilingual AI platform integrating:
- Indian Council of Agricultural Research (ICAR) knowledge
- AI-based advisory systems
Relevance to Biopharma
- Better bio-resource management
- Supports medicinal plants, bio-inputs, and bio-raw materials
- Strengthens farm-to-lab linkages
Circular Bioeconomy: Biogas Blended CNG
- Entire value of biogas excluded while calculating Central Excise duty on biogas-blended CNG
Significance
- Promotes bio-energy and waste-to-wealth
- Encourages investment in anaerobic digestion
- Links life sciences with clean energy transition
5. Support for Traditional Knowledge Systems (AYUSH)
Evidence-Based Traditional Medicine
- Upgradation of the WHO Global Traditional Medicine Centre, Jamnagar
Objective
- Promote:
- Scientific validation
- Global acceptance
- Evidence-based integration of traditional medicine
Boost to Ayurvedic Exports
- Scaling production of quality Ayurvedic products
- Benefits:
- Farmers (medicinal plants)
- Processing youth and MSMEs
- Aligns with global demand for:
- Wellness
- Preventive healthcare
Overall Significance of Biopharma SHAKTI
Health Security
- Reduces dependence on imported biologics
- Improves access to advanced therapies
Economic & Industrial
- High-value manufacturing and exports
- Job creation in R&D, manufacturing, trials, and regulation
Scientific & Technological
- Strengthens India’s biotech research base
- Builds regulatory science capacity
Challenges
- High capital and skill requirements
- Ensuring regulatory agility without compromising safety
- Need for strong industry-academia collaboration
