The Indian Pharmacopoeia Commission (IPC), an autonomous body under the Ministry of Health and Family Welfare, held a two-day national conference in September 2026 to discuss quality standards and safety practices for biosimilars—medicines manufactured using living cells or organisms. The event brought together 160 participants from drug regulators, pharmaceutical companies, universities and research bodies to address challenges in developing and evaluating these complex biological drugs.
The conference aligns with the Government’s Biopharma SHAKTI Vision, which aims to make India’s biopharmaceutical sector more innovative, self-reliant, competitive and globally recognised.
What the conference covered
The two-day meeting, held on September 10–11, 2026, at the Centre for Cellular and Molecular Platforms in Bengaluru, examined scientific and regulatory issues related to biosimilars. Topics included pharmacopoeial standards (quality benchmarks), how to measure and compare critical qualities, testing methods, how the body responds to these medicines, safety monitoring systems, and changing regulatory requirements worldwide.
A significant announcement was the release of the Indian Pharmacopoeia Reference Substance (IPRS) for Enoxaparin Sodium for bioassays. Enoxaparin Sodium is a blood thinner used to prevent and treat blood clots. This reference substance will serve as a standard material for laboratories testing the biological activity of this medicine, ensuring consistent and reliable results across India.
The conference featured technical sessions with experts from India’s drug regulators, international bodies like the World Health Organization and the United States Pharmacopeia, and leading biopharmaceutical organisations. Panel discussions brought together senior officials from regulatory agencies, industry and academia to discuss how India can improve its biosimilar sector through better quality assurance, stronger analytical capabilities, and alignment with global regulatory standards.
What this means for you
For patients, improved biosimilar quality standards mean safer, more reliable medicines at lower costs. For pharmaceutical companies and researchers in India, stronger reference materials and clearer quality guidelines support innovation and global competitiveness. The availability of authenticated Indian reference substances reduces dependence on imports and strengthens India’s pharmaceutical infrastructure under the self-reliance vision.