Representative image. | Photo Credit: AFP
It is urgently necessary to eliminate unnecessary animals on animals and to determine clear conditions for the requirement of comparative clinical evaluation for available biological similarities without risk and effectiveness, the members of the civil society said in a letter to the central drug standard control organization (CDSCO) instructions for biological instructions.
Also read: India is the first step to remove animals from the drug testing process
Biosimilar is biological medicine as other already approved biological medicine. Although it is not an exact copy, it is clinically similar in terms of safety, purity and efficiency. Biosimilars are developed as a more affordable alternative to reference biological, increasing access to treatment options and potentially reducing health care costs.
‘These instructions mean a significant step towards accessing affordable, rescue biologically similar biosimilars who suffer from serious diseases such as cancer, diabetes and autoimmune disorders. Biosimilars offers hope to provide lower alternatives to expensive biological drugs. Drugs to transform that it is that it is possible that it is necessary to be progressive, and that they are a progressive process that is a progressive process that is in a survey that is in survey that are released that are progressive that they are progressive procedures that are progressive that are progressive. They have been released, which is in the survey to be progressive.
“The proposed instructions for looking for reduced animal testing are encouraging. However, we look at increased cost and delayed access to available biologically similar. So by removing these tests, India can reduce production costs, accelerate biosimilation development and adhere to access to treatment and accessing Also dealing with treatment, as well as at the access level, as well as an approach to treatment and approach to treatment, as well as on the basis of treatment, as well as on treatment, and also cause access to and promoting ethical standards, as well as on treatment.
There is also a global trend to make a clinical effect of efficacy rather than the rule, added Mr. Goupemar.
“The draft instructions for skipping clinical evaluation, when biologically similar, is proven similar to laboratory tests, is a positive step. But the language used significant discretion to the licensing body and no risk of regulatory arbitrar.
The Group called CDSCO to ensure completed Biosimilars instructions remain exempt from any conflict of interest, she said that the design of 2025 instructions for similar biology offers the opportunity to promote the Indian health system.
“By eliminating animal studies, clarifying the exemption of clinical evaluation and priority, India can make Biosimilars available, reduce ethical concerns and strengthen Indian leadership in available medicine.
Published – 22 July 2025 17:30
