Biopharma SHAKTI Scheme

• 26 Mar 2026

Source: TH 

Why in News? 

The Union Budget 2026-27 introduced the Biopharma SHAKTI scheme to revolutionise the domestic production of biologics and biosimilars by shifting from traditional animal testing to advanced Non-Animal Methodologies (NAMs), e.g., organoids. 

What is the Biopharma SHAKTI Scheme? 

• About: 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." 

What are 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. 

Frequently Asked Questions (FAQs) 

1. What is Biopharma SHAKTI scheme? 
A Rs 10,000 crore flagship initiative (Union Budget 2026-27) to boost domestic production of biologics and biosimilars using Non-Animal Methodologies (NAMs). 

2. What are Non-Animal Methodologies (NAMs)? 
Innovative technologies like organoids and organ-on-a-chip that use human cells to replicate human biology, offering higher predictive accuracy than animal testing. 

3. How does the scheme address India’s disease burden? 
It prioritizes affordable therapies for Non-Communicable Diseases (NCDs), which account for 63% of all deaths in India. 

4. Why are organoids superior to animal models for testing biologics? 
Organoids are derived from human stem cells, allowing them to replicate human receptor binding and immune responses more accurately than animal cells. 

UPSC Civil Services Examination, Previous Year Question (PYQ) 

Q. Which of the following are the reasons for the occurrence of multi-drug resistance in microbial pathogens in India? (2019) 

1. Genetic predisposition of some people 
2. Taking incorrect doses of antibiotics to cure diseases 
3. Using antibiotics in livestock farming 
4. Multiple chronic diseases in some people 

Select the correct answer using the code given below.  

(a) 1 and 2   

(b) 2 and 3 only  

(c) 1, 3 and 4   

(d) 2, 3 and 4  

Ans: (b)