Biopharma SHAKTI Scheme

• The Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology, and Innovation) scheme is a flagship initiative designed to transition India from a leader in generic drugs to a global powerhouse for high-value biologics and biosimilars.
  • It aligns with the National Biopharma Mission (NBM), 2017, which aims to transform India into a USD 100 billion leading global biotech industry by 2025 and capture 5% of the global pharmaceutical share. 
• Financial Outlay: The government has allocated Rs 10,000 crore over 5 years (starting FY 2026–27) to build an end-to-end ecosystem for advanced biopharmaceuticals. 
• Disease Focus: Prioritises affordable domestic production of therapies for non-communicable diseases (NCDs) such as cancer, diabetes, and autoimmune disorders. 
• Manufacturing Shift: Encourages the adoption of NAMs like organoids, organ-on-a-chip, and 3D bioprinting to reduce costs and improve the predictive accuracy of drug safety (replicate human biology more accurately than animal cells). 
• Infrastructure & Academia: Establishment of 3 new National Institutes of Pharmaceutical Education and Research (NIPERs).
  • Upgradation of 7 existing NIPERs into centers of excellence for translational research. 
  • Creation of a national network of over 1,000 accredited clinical trial sites to accelerate drug development. 
• Regulatory Reform: Strengthening the Central Drugs Standard Control Organisation (CDSCO) with a dedicated “Scientific Review Cadre” to align approval timelines with international benchmarks. 
• Significance: The initiative responds to the rise of NCDs like diabetes, cancer, and cardiovascular diseases—which now account for 63% of all deaths in India—as well as to 100% (and potential 250%) US tariffs on branded and patented pharmaceutical drugs.  

India’s Pharmaceutical Sector 

• Global Market Standing: India remains the 3rd largest pharmaceutical producer by volume (11th by value), supplying 20% of global generic medicines and a majority of the world’s diphtheria, tetanus and pertussis (DPT), Bacillus Calmette-Guerin (BCG) and measles vaccines. 
• Economic Scale: As per the Economic Survey 2025-26, the sector reached an annual turnover of Rs 4.72 lakh crore in FY25, with over 10,500 manufacturing units and a 7% CAGR in exports over the last decade. 
• Expansion into Med-Tech: India has become globally competitive in medical devices, exporting high-end equipment like MRI scanners, CT scanners, and cardiac stents to 187 countries. 

Biologics and Biosimilars 

• Biologics (Innovator Drugs): Unlike traditional “small-molecule” drugs (like Aspirin) made through chemical synthesis, biologics are produced using living systems (bacteria, yeast, or animal cells).
  • They are massive—often 200 to 1,000 times larger than chemical drugs—with complex 3D structures. E.g., Insulin, Monoclonal Antibodies (mAbs) for cancer, vaccines, and gene therapies. 
• Biosimilars (Generic of Biologics):  Biosimilar is a biologic product that is highly similar to a previously approved “reference” biologic, with no clinically meaningful differences in safety or efficacy. They are typically 30%–70% cheaper than the original biologic.
  • Because they are made in living cells, it is impossible to create an identical copy. Therefore, they are “similar,” not “generic.” 

Non-Animal Methodologies (NAMs)

• About:NAMs, also known as New Approach Methodologies, are a suite of innovative scientific technologies used to assess the safety and efficacy of drugs, chemicals, and biologics without relying on traditional animal testing.
  • NAMs prioritize human-relevant data by using human cells, tissues, and sophisticated computer models, aiming to replace, reduce, or refine (the 3Rs) the use of animals in research. 
• Core Technologies of NAMs:
  • Organ-on-a-Chip (OoC): Microfluidic devices lined with living human cells that mimic the physiological environment and mechanical forces (like blood flow or breathing) of specific organs. 
  • Organoids: 3-dimensional, self-organizing “mini-organs” grown from human stem cells that replicate the complex structure and genetic profile of a patient’s actual organ. 
  • 3D Bioprinting: Use “bio-inks” (cells and nutrients) to print human tissue structures layer-by-layer, allowing researchers to study how drugs penetrate solid tumors or skin. 
  • In Silico Models: Advanced AI and computer simulations that predict how a new molecule will interact with the human body based on massive datasets of known chemical reactions. 
  • Ex Vivo Systems: Using human tissues or organs (often from surgical leftovers or donors) kept alive outside the body for short-term testing. 
• Advantages for Drug Development: NAMs offer higher predictive accuracy by using human biology, avoiding tragedies like the 2006 Northwick Park trial where a drug safe in monkeys proved toxic to humans (multiple organ failure).
  • They also deliver cost and time efficiency, reducing drug development costs by 10–26% and shortening candidate identification by nearly 20%. 
  • It enables precision medicine through patient-derived organoids for personalized treatment.  
  • Regulatory support has strengthened with laws such as India’s New Drugs and Clinical Trials (Amendment) Rules 2023 formally recognizing NAMs as valid alternatives to animal data.