The Indian Pharmacopoeia Commission (IPC) is taking efforts to develop more biosimilar monographs or quality standards in alignment with the government’s Rs. 10,000 crore Biopharma Shakti scheme announced on February 1, 2026 in the Union Budget 2026 by Union Finance Minister Nirmala Sitharaman. Bio Pharma Shakti project will further boost the efforts of IPC in Biosimilars, says Dr V Kalaiselvan, secretary-cum-scientific director, IPC.
With a committed outlay of Rs. 10,000 crore over the next five years, the Biopharma Shakti programme is designed to build an end-to-end ecosystem for the Indian pharma industry to develop and manufacture biologics and biosimilar drugs, which represent the fastest-growing segment of the global pharmaceutical market.
Dr Kalaiselvan further added that Biopharma Shakti scheme is a significant development for the pharma industry as the Indian Pharmacopoeia (IP) is at par with other Pharmacopoeias globally in terms of developing biosimilar monographs. We have renewed our focus in developing more biosimilar monographs. Biosimilars are also called as complex molecules or next generation therapeutics and have paved the way for development of innovative therapies for non-communicable diseases (NCDs) like diabetes, cancer and autoimmune disorders.
Biopharma Shakti project marks a historic and strategic shift in India’s pharmaceutical journey from being a global leader in generics to emerging as a global bio-pharma manufacturing powerhouse. By strengthening critical enablers such as research infrastructure, clinical trial capacity, regulatory capability, skilled manpower, and advanced manufacturing facilities, Biopharma Shakti aims to significantly reduce India’s dependence on imports for complex biologic therapies. This is particularly vital in the context of rising NCDs, where biologics are becoming the standard of care.
IPC released the 10th edition of Indian Pharmacopoeia 2026 (IP-2026) on January 02, 2026 in which it has introduced a total of 3,340 monographs or quality standards for medicines. IP-2026 has covered key therapeutic categories, including anti-tuberculosis, anti-diabetic and anti-cancer medicines for use in national health programmes.
IP-2026 contains a total of 121 new monographs including 88 drug substances, dosage forms, and pharmaceutical aids, 05 vitamins, minerals, amino acids, fatty acids etc, 02 biotechnology derived therapeutic products, 03 human vaccines, 02 blood related products, 20 blood and blood component monographs, and 01 veterinary vaccines monographs.
Biosimilars play a critical role in managing NCDs by increasing access to high-cost, life-saving, biologic therapies. By offering a more affordable, highly similar alternative to reference products, they significantly lower healthcare costs, which is especially vital in low- and middle-income countries (LMICs) dealing with the growing, high-cost, burden of chronic illnesses.
Biosimilars typically offer a 15% to 35% lower cost than innovator biologics, allowing for wider patient access in resource-limited settings. Key areas benefiting from biosimilars include cancer (oncology), chronic autoimmune diseases (rheumatoid arthritis), diabetes, and blood-related conditions. The adoption of biosimilars helps reduce the overall financial burden on patients and public healthcare systems, enabling more patients to receive treatment. By providing accessible, quality-assured alternatives to expensive biologics, biosimilars assist in reaching targets to reduce premature mortality from NCDs. |