Swadeshi Jagran Manch (SJM), economic wing of the Rashtriya Swayamsewak Sangh (RSS), urged the Central Drugs Standard Control Organisation (CDSCO), the apex drug regulatory authority, to bring more clarity in its draft guidelines to ensure production of high-quality and cost-effective biosimilars in the country.
In a letter to the Director General of CDSCO, SJM sought safeguards for the Indian industry from “international pressures for regulations” that favour multi-national pharma companies.
The CDSCO had recently issued the 2025 draft guidelines on similar biologics, also called biosimilars.
“Though the draft guidelines represent a pivotal advancement in making affordable, life-saving biosimilars accessible to millions of Indians suffering from chronic and life-threatening conditions such as cancer, diabetes, and autoimmune disorders it requires more clarity and direction,” the SJM letter reads.
The SJM appreciated the draft guidelines for embracing the “3Rs principle” (replacement, reduction, refinement) as it reflects 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, it said.
