Eliminate unnecessary animal studies, establish clear conditions for comparative clinical trials, say healthcare advocates

The Hindu

5 days ago

There is an urgent need to eliminate unnecessary animal studies, and establish clear conditions for requiring comparative clinical trials for affordable biosimilars without compromising safety and efficacy, members of civil society said in a letter to the Central Drugs Standard Control Organisation (CDSCO) on the draft guidelines on biosimilars.
Also read:India takes first step to remove animals from drug-testing process
A biosimilar is a biological medicine like another already approved biological medicine. While it is not an exact copy, it is clinically similar in terms of safety, purity, and potency. Biosimilars are developed to be a more affordable alternative to the reference biologic, increasing access to treatment options and potentially lowering healthcare costs.
'These guidelines mark a significant step toward making affordable, lifesaving biosimilars available to Indians suffering from serious illnesses like cancer, diabetes, and auto-immune disorders like arthritis. Biosimilars offer hope to patients by providing lower-cost alternatives to expensive biologic medicines. In India, where many struggle to afford basic healthcare, these drugs can transform lives. The draft guidelines are progressive as they have simplified the approval process, but we believe additional changes can make biosimilars even more accessible, ethical, and affordable, while maintaining safety and quality,'' the group, which includes patient advocates, healthcare organisations, and concerned citizens, said in its letter.
'The proposed guidelines on seeking reduced animal testing are encouraging. However, without a complete waiver, we are looking at increased costs and delayed access to affordable biosimilars. So, by eliminating these tests, India can lower production costs, speed up the biosimilar development, and uphold ethical standards, as well as make biosimilars more affordable for patients,' K.M. Gopakumar, co-convenor of the Working Group on Access to Medicines and Treatment, a civil society network for affordable healthcare, said.
There is also a global trend to make clinical efficacy studies an exception rather than a rule, Mr. Gopakumar added.
'The draft guidelines' provision to skip clinical trials when a biosimilar is proven similar through lab tests is a positive step. But the language used grants significant discretion to the licensing authority and carries the risk of regulatory arbitrariness. Moreover, it could be exploited by originator companies to initiate legal action against biosimilar manufacturers, alleging potential compromises in safety and quality,'' he warned, adding that the group is demanding a clear definition for the situation where a biosimilar developer needs to carry out comparative clinical trials.
Calling on the CDSCO to ensure the finalised guidelines on biosimilars remain free from any conflict of interest, the group said that the 2025 Draft Guidelines on Similar Biologics offer an opportunity to advance India's healthcare system.
'By removing animal studies, clarifying clinical trial waivers, and prioritising affordability, India can make biosimilars more accessible, reduce ethical concerns, and reinforce India's leadership in affordable medicine. We request that you incorporate these recommendations and engage with civil society, patient groups, and healthcare advocates as you finalise the guidelines,'' the group has urged the CDSCO.