Biopharma SHAKTI Initiative

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