National Conference on Quality and Safety of Biosimilars

The Indian Pharmacopoeia Commission (IPC) organised a two-day National Conference on "Quality and Safety of Biosimilars: Strengthening India's Biopharma SHAKTI Vision" in Bengaluru.

Key Highlights

  • The conference aimed at strengthening India's biopharmaceutical ecosystem through quality, innovation and regulatory excellence.
  • It focused on improving the quality, safety, regulatory evaluation and development of biosimilars through collaboration among regulators, industry, academia and research organisations.
  • IPC released the Indian Pharmacopoeia Reference Substance (IPRS) for Enoxaparin Sodium for bioassays, providing an authenticated reference material for accurate and consistent testing of biological activity.

About Biosimilars

  • Definition: Biosimilars are highly similar versions of approved biological medicines.
  • Uses: Treatment options for cancer, arthritis, kidney diseases, psoriasis, Crohn's disease and colitis.
  • Benefits: Improve patient access to essential medicines, offer additional treatment options and may reduce healthcare costs.

Biopharma SHAKTI Vision

  • Announced in the Union Budget 2025-26 with an outlay of ₹10,000 crore over five years.
  • Aims to strengthen India's ecosystem for biologics and biosimilars, promote domestic manufacturing and reduce import dependence.
  • Research and Clinical Infrastructure:
  • Establishment of three new NIPERs (National Institutes of Pharmaceutical Education and Research).
  • Upgradation of seven existing NIPERs.
  • Creation of over 1,000 accredited clinical trial sites.

About Indian Pharmacopoeia Commission (IPC)

  • An autonomous institution under the Ministry of Health and Family Welfare.
  • Responsible for developing standards for medicines and strengthening pharmaceutical quality infrastructure.
  • Publishes the Indian Pharmacopoeia (IP), the official book of drug standards for India.

Significance for India

  • Strengthens India's position as a global hub for affordable biosimilars and generics.
  • Supports Atmanirbhar Bharat by reducing import dependence in biologics.
  • Enhances regulatory credibility, boosting exports and global trust in Indian biopharma products.