SJM calls for streamlining approvals and waiving animal trials to improve access to biosimilar products

“Streamline the approval process for biosimilars and waive animal trials when laboratory data is available,” says the Swadeshi Jagran Manch (SJM), in its letter to the drug regulatory authority, on the draft guidelines for bio-similar products.

“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,” SJM, the economic wing of the Rashtriya Swayamsewak Sangh (RSS), said in its letter to the Central Drugs Standard Control Organisation (CDSCO), advocating a total waiver of animal studies when comprehensive laboratory tests demonstrate high similarity between a biosimilar and its reference product.

“We want international practices to be followed, and without delays,” so these products are made available to patients, Ashwani Mahajan, SJM’s National Co-Convenor, told businessline. “Requirements for animal studies or unclear clinical trial mandates can drive up production expenses, making biosimilars unaffordable for many Indians, particularly those in rural and low-income communities,” he said, in the letter.

Pointing to the draft’s inclusion of the “3Rs principle” (Replacement, Reduction, Refinement),” the letter said, it reflected 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,” the letter added.

Referring to certain clinical trials when biosimilarity to the innovator product is established, the letter called for “explicit criteria” when waivers are permitted to reduce ambiguity that could lead to “inconsistent application and delays,” besides leaving it open to corrupt practices. “Define specific, evidence-based conditions when clinical efficacy trials will be needed as reflected in the case of EMA Reflection Paper,” the letter said.

The letter further called for streamlining the approval process “to eliminate cost-driving requirements, ensuring biosimilars are priced affordably for all patients.” The 2025 Draft Guidelines on Similar Biologics shows an advancement in making affordable, life-saving biosimilars accessible to Indians suffering from chronic and life-threatening conditions such as cancer, diabetes and autoimmune disorders it requires more clarity and direction, the letter said, stressing the need for a framework that would enhance support and speedy access.

Published on August 1, 2025