How BioPharma SHAKTI Can Transform Biologics
Context:
The 2026 Union Budget introduced the Biopharma SHAKTI strategy to significantly boost the domestic production of biologics and their generic counterparts, biosimilars.
Scientists are increasingly advocating for a crucial shift away from traditional animal testing toward bioengineered, human-relevant systems, broadly categorized as non-animal methodologies (NAMs).
Understanding Biologics and Biosimilars:
Biologics:
Unlike traditional chemically synthesized small-molecule drugs, biologics are a growing class of large, highly complex molecules produced by living cells.
It includes critical therapeutics such as monoclonal antibodies, vaccines, and insulin, which are becoming globally popular for treating a variety of chronic diseases.
Biosimilars:
These are the equivalent of generic drugs for the biologics sector.
They are reverse-engineered versions of the original biologic product created once the original patent expires, designed to make expensive treatments more accessible to the wider public.
The Need for Non-Animal Methodologies (NAMs):
Limitations of Animal Testing:
A major flip side to developing biologics is that traditional animal models do not reliably predict their safety and efficacy in humans.
A tragic 2006 phase I clinical trial in London, where six healthy men suffered catastrophic reactions to a biologic drug despite it passing animal trials, serves as a stark reminder of these limitations.
Advanced Alternatives:
To address this fundamental flaw, scientists are shifting to bioengineered systems like organoids, organ-on-a-chip, and 3D bioprinting.
Policy Support:
India took a progressive step with the New Drugs and Clinical Trials (Amendment) Rules 2023, which formally promotes the use of NAMs in the development of novel drugs.
However, their full potential remains largely untapped specifically within the domain of biologics and biosimilars.
Challenges Hindering the Biopharma SHAKTI Vision:
Patent Evergreening:
Pharmaceutical companies often utilize strategies to extend their exclusive rights over an original biologic.
Regulatory Bottlenecks:
Before reaching the market, biosimilars must be approved by the Central Drugs Standard Control Organisation (CDSCO), India's apex regulatory body.
While India is updating its biosimilar guidelines to accommodate NAMs, implementation has been remarkably slow.
The updated guidelines remain in draft form, and the regulatory confidence in independently validated NAM models is still evolving.