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

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

 

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 first-hand.

 

“We met the Drugs Controller in Delhi and had a fruitful discussion with him on how the Indian regulatory system is working to ensure inspections and quality audits. We also discussed the nuances of Indian Pharmacopoeia,” said Abebe. 

 

The delegation is currently touring Maharashtra, which hosts nearly 900 allopathic manufacturing facilities, to study how state Food and Drug Administrations (FDAs) monitor and audit industry operations.

 

Abebe also said that Ethiopia is evaluating the Indian Pharmacopoeia standards against other global pharmacopoeias and her ministry’s technical team would soon offer a recommendation.

 

“We understand that if we allow the Indian Pharmacopoeia to be the standard when we import drugs from India, there would be at least a 15-20 per cent price differential. As a result, we can import more volumes,” she said.

 

Ethiopia’s pharmaceutical procurement agency underscored the country’s reliance on India for essential medicines. Abdulkedir Gelgelo, director general, Ethiopian Pharmaceutical Procurement Services, said Ethiopia imports nearly 70 per cent of its medicines from India, and almost its entire vaccine requirement through global agencies. Most antibiotics, anti-cancer drugs apart from common medicines are sourced from India.

 

Industry representatives argue that global acceptance of Indian Pharmacopoeia could significantly reduce export costs and make Indian drugs more affordable to developing nations.

 

Bhavin Mehta, vice-chairman of Pharmexcil and director, Kilitch Drugs, said that United States Pharmacopeia (USP) is currently used in over 140 countries, but is significantly more expensive to adopt.

 

“It is expensive to buy impurities and standards from USP, while Indian Pharmacopoeia is relatively affordable. Similar sets of tests are mentioned in Indian Pharmacopoeia as well. We are working to ensure Indian Pharmacopoeia is accepted more globally. For now, we have set a target to ensure Indian Pharmacopoeia is accepted in 50 countries. Already 18 countries accept it and Ethiopia is actively studying it,” Mehta said, adding that adoption would lower export costs for Indian manufacturers.

 

In her response to the Rajya Sabha in August, Minister of State for Health Anupriya Patel said the Indian Pharmacopoeia Commission has stepped up foreign engagement, organising two Policy Makers’ Fora in 2024 and 2025 with participation from 37 countries, mostly from the Global South. Additionally, India hosted the 15th international meeting of World Pharmacopoeias in February 2025, in collaboration with World Health Organization (WHO), to strengthen global regulatory cooperation.

 

“These initiatives have resulted in Indian Pharmacopoeia currently being recognised in 17 countries, of which 12 have recognised it in the last two years,” she said, adding that efforts continue to expand acceptance via bilateral technical discussions and participation in global conferences.

 

India’s growing influence also stems from the Indian Pharmacopoeia Commission becoming a permanent member of the Pharmacopoeial Discussion Group (PDG) in September 2023, alongside the US, European, and Japanese pharmacopoeias — an important milestone in harmonising global standards.

 

Countries that already recognise Indian Pharmacopoeia include Afghanistan, Ghana, Nepal, Mauritius, Suriname, Nicaragua, Bhutan, Mozambique, Solomon Islands, Sri Lanka, Nauru, Malawi and Guyana, along with the recently added Fiji, which signed a pact enabling Indian Pharmacopoeia-based approvals for Indian-made medicines, eliminating duplicate testing and easing market access.

 

India is the world’s largest supplier of generic medicines, accounting for 20 per cent of global volume and exporting to 200 countries, yet Indian Pharmacopoeia has historically struggled for recognition compared to USP, BP, and EP. The push to expand acceptance is expected to boost exports, cut regulatory costs and strengthen India’s position as the “pharmacy of the world.”

 

For developing countries grappling with rising healthcare costs, the adoption of Indian Pharmacopoeia could translate into cheaper essential medicines and expanded access.

 

With growing diplomatic outreach, regulatory credibility and industry backing, India is gradually building a global ecosystem around its pharmacopoeial standards — quietly but assertively reshaping pharmaceutical trade dynamics.

 

What is Pharmacopoeia?

 

A pharmacopoeia is an official book of standards for medicines published by the government or an authorised body which lays down guidelines that ensure the quality, purity, strength, and identity of drugs, and related substances. 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 also protect patient safety.