Indian Pharmacopoeia Commission (IPC) Organizes National Conference on Quality and Safety of Biosimilars: Strengthening India’s Biopharma SHAKTI Vision

Key Highlights:

• The Indian Pharmacopoeia Commission (IPC) organized a National Conference on Quality and Safety of Biosimilars in Bengaluru on September 10–11, 2026.
• The conference aimed to strengthen India’s Biopharma SHAKTI Vision through innovation, self-reliance, quality, and global competitiveness.
• A major outcome was the release of the Indian Pharmacopoeia Reference Substance (IPRS) for Enoxaparin Sodium for bioassays.
• This IPRS serves as an authenticated reference material for bioassay testing of Enoxaparin Sodium, an anticoagulant.
• The initiative aligns with the Atmanirbhar Bharat vision by enhancing India’s indigenous pharmaceutical quality infrastructure.

Detailed Insights:

• The conference addressed scientific and regulatory challenges in the development, evaluation, and safety of biosimilars.
• It emphasized pharmacopoeial standards, critical quality attributes, analytical characterization, and pharmacovigilance.
• The event fostered collaboration among regulatory authorities, industry, academia, and research organizations.
• Strengthening pharmacopoeial standards and regulatory cooperation is crucial for ensuring the quality and safety of biosimilars.
• The conference contributes to the vision of Viksit Bharat by advancing harmonized standards and regulatory excellence in the biopharmaceutical sector.

Key Concepts Involved:

• Indian Pharmacopoeia Commission (IPC): An autonomous institution under the Ministry of Health and Family Welfare, setting standards for drugs in India.
• Biosimilars: Biological products highly similar to an already approved biological medicine (the reference product).
• Indian Pharmacopoeia Reference Substance (IPRS): Authenticated reference materials used for testing and ensuring the quality of pharmaceutical products.
• Biopharma SHAKTI Vision: A government initiative to strengthen India's biopharmaceutical ecosystem through innovation and self-reliance.