SJM demands elimination of animal studies, more clarity on Biosimilar Guidelines
The Swadeshi Jagran Manch (SJM), a public interest platform committed to self-sufficiency and equitable access to medical treatments, has requested the central drug regulator to eliminate animal studies entirely when comprehensive laboratory tests demonstrate high similarity between a biosimilar and its reference product and ensure that biosimilars are priced affordably for all patients.
In a letter to the head of the Central Drugs Standard Control Organisation (CDSCO), the SJM has demanded enhancement to the draft guidelines on Similar Biologics, released by the drug regulator recently for finalisation.
“Biosimilars hold immense promise for transforming healthcare in India by offering cost-effective alternatives to expensive biologic medicines. In a country where many patients face significant financial barriers to accessing basic healthcare, these guidelines are a beacon of hope. However, to maximize their impact and ensure that biosimilars reach all who need them, we strongly urge the CDSCO to consider the following enhancements to the Draft Guidelines,” it said.
The Manch applauded the draft guidelines for embracing the 3Rs principle (Replacement, Reduction, Refinement), reflecting India’s commitment to ethical scientific practices and alignment with global standards for animal welfare. Modern technologies, including in-vitro assays, organ-on-chip models, and computational simulations, provide robust, accurate, and humane alternatives to confirm the safety and biosimilarity of these drugs. These methods are often faster and more precise than animal studies, reducing both ethical concerns and development costs.
However, it added, the Draft Guidelines the waiving of animal studies is at the discretion of the CDSCO. The Draft Guideline reads: “On the basis of the totality of quality and nonclinical in vitro data available and the extent to which there is residual uncertainty about the similarity of a similar biologic and its RBP, it is at the discretion of Licensing Authority to waive or not to waive a requirement for additional nonclinical in vivo animal studies”. As a result, the waiver is at the discretion of the CDSCO.
“This provision not only risks increasing biosimilar development cost but also goes against the practices of the leading regulatory authorities,” said, SJM. Prominent regulatory authorities like the UK MHRA, European Medicine Agency (EMA,) Health Canada, and USFDA have either eliminated or phased out mandatory animal testing for biosimilars.
“Waiving animal studies entirely when comprehensive laboratory tests demonstrate high similarity between a biosimilar and its reference product,” demanded SJM.
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