BioPharma SHAKTI Scheme

The Biopharma SHAKTI scheme has the potential to fundamentally reshape how biologics are developed in India. It will aid in accelerating the transition from traditional animal-based testing to advanced human-relevant, non-animal models (NAMs). Read here to learn more.

The Union Budget 2026-27 marked a major shift in India’s pharmaceutical strategy with the launch of the Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology, and Innovation) scheme.

The initiative aims to move India beyond its traditional dominance in generics to become a global hub for high-value biologics and biosimilars, while embracing cutting-edge Non-Animal Models (NAMs).

What is the Biopharma SHAKTI Scheme?

• The Biopharma SHAKTI scheme is a flagship programme designed to upgrade India’s pharmaceutical ecosystem from volume-driven generics to innovation-driven biologics.
• It complements earlier initiatives like the National Biopharma Mission (2017), which aimed to position India as a $100 billion biotech economy.
• The BioPharma SHAKTI scheme reflects a strategic transition toward complex, high-value therapeutics such as monoclonal antibodies, vaccines, and gene therapies.

Financial Outlay and Duration

• The government has committed ₹10,000 crore over five years (starting FY 2026-27) to create a comprehensive ecosystem for research, development, and manufacturing of advanced biopharmaceuticals.

Focus on Disease Burden

The scheme prioritises affordable therapies for non-communicable diseases (NCDs) such as:

• Cancer
• Diabetes
• Cardiovascular diseases
• Autoimmune disorders

This is critical since NCDs account for nearly 63% of total deaths in India, necessitating scalable and cost-effective biologic therapies.

Key Pillars of the Biopharma SHAKTI Scheme

Transition to Advanced Manufacturing Technologies

A defining feature of the scheme is the promotion of Non-Animal Models (NAMs), replacing traditional animal testing.

Technologies include:

• Organoids (mini human organs grown in labs)
• Organ-on-a-chip systems
• 3D bioprinting
• AI-based in silico drug modelling

This shift enhances predictive accuracy, ethical compliance, and cost efficiency in drug development.

Strengthening Infrastructure and Academia

The scheme emphasises institutional capacity building:

• Establishment of 3 new National Institutes of Pharmaceutical Education and Research (NIPERs)
• Upgradation of 7 existing NIPERs into Centres of Excellence
• Creation of a network of 1,000+ accredited clinical trial sites

This integrated ecosystem aims to bridge the gap between basic research and commercial application (translational research).

Regulatory Reforms

The scheme proposes strengthening the Central Drugs Standard Control Organisation (CDSCO) by:

• Creating a Scientific Review Cadre
• Streamlining approval processes
• Aligning timelines with global standards

This will reduce delays and improve India’s attractiveness for global clinical trials and investments.

Strategic Response to Global Challenges

The scheme also responds to:

• Rising global protectionism (e.g., US tariffs on pharma products)
• Supply chain vulnerabilities
• Need for self-reliance in critical therapeutics

Understanding Biologics and Biosimilars

Biologics (Innovator Drugs)

Biologics are complex drugs produced using living systems such as bacteria, yeast, or mammalian cells.

Examples include:

• Insulin
• Monoclonal antibodies (for cancer)
• Vaccines
• Gene therapies

They are significantly larger and more complex than chemical drugs like Aspirin, making their development technically demanding.

Biosimilars

Biosimilars are highly similar versions of approved biologics with no clinically meaningful differences in safety or efficacy.

• Typically 30-70% cheaper than original biologics
• Cannot be exact copies due to biological complexity
• Crucial for improving affordability and access

What are Non-Animal Models (NAMs)?

NAMs are modern scientific tools that replace or reduce animal testing by using human-relevant systems.

They follow the 3Rs principle:

• Replace
• Reduce
• Refine

Core Technologies

• Organ-on-a-Chip: Microfluidic devices that simulate human organ functions such as blood flow or respiration.
• Organoids: 3D mini-organs derived from stem cells that replicate human organ structure and genetics.
• 3D Bioprinting: Layer-by-layer printing of tissues using bio-inks to study drug interactions.
• In Silico Models: AI-based simulations predicting drug behaviour using large datasets.
• Ex Vivo Systems: Testing on human tissues maintained outside the body.

Advantages in Drug Development

• Higher Predictive Accuracy: Based on human biology rather than animal models
• Cost Efficiency: Reduces drug development costs by 10–26%
• Time Saving: Speeds up candidate identification by ~20%
• Ethical Benefits: Reduces animal experimentation
• Precision Medicine: Enables patient-specific therapies using organoids

The importance of NAMs is underscored by incidents like the Northwick Park clinical trial (2006), where a drug safe in animals caused severe reactions in humans.

India’s Pharmaceutical Sector: Current Status

Global Standing

• 3rd largest producer by volume
• 11th largest by value
• Supplies 20% of global generic medicines

India is also a major supplier of vaccines, such as:

• DPT
• BCG
• Measles

Economic Scale

• ₹4.72 lakh crore turnover (FY25)
• Over 10,500 manufacturing units
• ~7% CAGR in exports over the last decade

Expansion into Med-Tech

India has emerged as a competitive exporter of:

• MRI scanners
• CT scanners
• Cardiac stents

Exports reach 187 countries, indicating strong global integration.

Significance of the Biopharma SHAKTI Scheme

• Moving Up the Value Chain: The scheme enables India to transition from low-cost generics to high-value biologics, increasing global competitiveness.
• Boost to Innovation Ecosystem: By integrating academia, industry, and regulators, it fosters a holistic innovation ecosystem.
• Healthcare Accessibility: Affordable biosimilars will improve access to treatment for chronic and life-threatening diseases.
• Strategic Autonomy: Reduces dependence on imports and strengthens Atmanirbhar Bharat in pharmaceuticals.
• Ethical and Scientific Advancement: Adoption of NAMs aligns India with global best practices in ethical research and advanced science.

Challenges

• High capital and technology requirements
• Skill gaps in advanced biomanufacturing
• Regulatory adaptation to new technologies
• Global competition from the US, the EU, and China

Way Forward

• Strengthening public-private partnerships
• Investing in biotech skilling and training
• Enhancing global collaborations
• Fast-tracking regulatory reforms

Conclusion

The Biopharma SHAKTI scheme represents a paradigm shift in India’s pharmaceutical strategy, combining innovation, affordability, and ethical science. By leveraging biologics, biosimilars, and NAMs, India is poised to emerge as a global leader in next-generation healthcare solutions, while addressing its domestic disease burden effectively.