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18 nations and rising: India quietly builds global support for its Pharmacopoeia

Business Standard

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November 26, 2025

India is intensifying efforts to secure broader global acceptance of the Indian Pharmacopoeia, aiming to push its recognition to 50 countries.

- SOHINI DAS

This comes even as an Ethiopian government delegation, currently visiting India, said it is actively studying the Indian Pharmacopoeia and its regulatory ecosystem.

A Pharmacopoeia is an official regulatory reference published by a government or authorised body that defines legally binding standards for quality, purity, strength, and testing of medicines.

It includes detailed monographs outlining identification methods, allowable impurities, and analytical procedures for raw materials and finished drugs.

By setting limits for contaminants and ensuring uniform quality control, pharmacopoeias protect patient safety.

The initiative — largely pursued through technical diplomacy, regulatory collaborations and on-ground audits — has begun yielding measurable results, with 17 countries already recognising Indian Pharmacopoeia, including 12 in the past two years, according to a Rajya Sabha reply in August 2025. Currently the tally stands at 18.

A high-level Ethiopian delegation, led by State Minister Frehiwot Abebe from Ministry of Health, visited pharmaceutical and vaccine manufacturing facilities in India this week to assess quality standards and regulatory processes firsthand.

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