Bring more clarity in draft guidelines to ensure production of high-quality cost-effective biosimilars SJM to CDSCO

New Delhi, Jul 30 (PTI) The Swadeshi Jagran Manch has urged apex drug regulatory authority CDSCO to bring more clarity in its draft guidelines to ensure production of high-quality and cost-effective biosimilars in the country.
    The RSS affiliate also sought safeguard measures for the Indian industry from "international pressures for regulations" that favour multi-national pharma companies.
    The Central Drugs Standard Control Organisation (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 said in a letter to the CDSCO.
    The SJM said it 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.
    "These methods are often faster and more precise than animal studies, reducing both ethical concerns and development costs," it added.
    However, the draft guidelines stipulating that it will be the discretion of the CDSCO to decide whether a requirement of "additional non-clinical in vivo animal studies" should be waived or not, poses a "risk" of increasing biosimilar development cost, the SJM noted.
    This provision also goes against the practices of the leading regulatory authorities in other countries, it added.
    "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 national co-convenor Ashwani Mahajan noted in the letter.
    "Against this background, we recommend waiving animal studies entirely when comprehensive laboratory tests demonstrate high similarity between a biosimilar and its reference product," he added.
    According to the SJM, the draft guidelines' provision to waive certain clinical trials when biosimilarity is established through analytical and functional studies is a forward-thinking measure, saying this approach can significantly reduce development costs and expedite market entry, which is critical for patients awaiting affordable treatments.
    However, the lack of explicit criteria in the guidelines for when waivers are permitted introduces ambiguity, potentially leading to inconsistent application and delays as well as "room for corrupt practices", it said, stressing the need to establish "clear conditions" for conduct of clinical trials.
    "To enhance clarity and efficiency, we urge the CDSCO to define specific, evidence-based conditions when clinical efficacy trials will be needed as reflected in the case of EMA Reflection Paper, ensure consistent application of these criteria for waivers across all biosimilar applications," the SJM said.
    "A transparent and standardized waiver process will enable manufacturers to prioritise the production of high-quality, cost-effective biosimilars, ultimately benefiting patients across India," it added.
    The SJM suggested that clear provisions be made to streamline the approval process to eliminate cost-driving requirements and ensure that biosimilars are priced affordably for all the patients, calling for safeguarding India's generic and biosimilar industry from "international pressures to adopt costly regulations that favour multinational pharmaceutical companies".

(This story has not been edited by THE WEEK and is auto-generated from PTI)