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The Union Budget 2026–27 introduced the Biopharma SHAKTI scheme, aimed at transforming India’s pharmaceutical sector by promoting advanced biologics and reducing reliance on animal testing through Non-Animal Methodologies (NAMs). This marks a shift towards innovation-driven, human-relevant drug development.

Background: India’s Pharmaceutical Strength and Emerging Needs

India has established itself as a global leader in pharmaceuticals, ranking among the top producers of generic medicines and supplying a significant share of vaccines worldwide. The sector has achieved substantial scale, with a turnover of ?4.72 lakh crore (FY25) and strong export growth.

However, the next phase of growth requires a transition from generics to high-value biologics and biosimilars, especially in response to the rising burden of non-communicable diseases (NCDs) such as cancer, diabetes, and cardiovascular disorders.

Biopharma SHAKTI Scheme: Key Features

• Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology, and Innovation) is designed to create an end-to-end ecosystem for advanced biopharmaceuticals.
• With a financial outlay of ?10,000 crore over five years, the scheme focuses on strengthening research, manufacturing, and regulatory capacity. It aligns with earlier initiatives such as the National Biopharma Mission.
• The programme promotes the development of affordable biologics, enhances infrastructure through expansion of institutions like NIPERs, and builds a nationwide clinical trial network to accelerate drug development. It also aims to streamline regulatory processes by strengthening institutions such as CDSCO.

Understanding Biologics and Biosimilars

Unlike conventional small-molecule drugs, biologics are produced using living systems and have complex molecular structures. They include products such as insulin, monoclonal antibodies, and vaccines, which are crucial for treating chronic and life-threatening diseases.

Biosimilars are cost-effective alternatives to these biologics, offering similar therapeutic benefits at significantly lower costs. Their development is critical for improving accessibility and affordability of advanced treatments.

Non-Animal Methodologies (NAMs): A Paradigm Shift

A central feature of the scheme is the promotion of Non-Animal Methodologies (NAMs), which aim to replace or reduce traditional animal testing.

NAMs rely on human-relevant models and advanced technologies such as organoids, organ-on-a-chip systems, 3D bioprinting, and AI-based simulations. These approaches replicate human physiology more accurately, enabling better prediction of drug safety and efficacy.

They also align with global ethical standards and the principle of the 3Rs—Replace, Reduce, Refine in animal testing.

Advantages of NAMs

NAMs offer several advantages over conventional methods. They improve predictive accuracy, reducing the risk of adverse outcomes in clinical trials. They also enhance efficiency by lowering development costs and shortening timelines.

Furthermore, they enable precision medicine, as patient-derived models can be used to design personalised therapies. Regulatory recognition of NAMs in India has further strengthened their adoption.