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Global recognition to the Indian Pharmacopoeia (IP) as a book of standard has been a major issue the Indian pharmaceutical exporters, including the merchant exporters, have been facing for a long time now. Though India is the world's largest supplier of generic medicines and accounts for 20 per cent of the worldwide supply of generics by volume, only a handful of countries have so far accepted IP as a book of standard. Afghanistan, Ghana, Nepal, Mauritius, Suriname, Nicaragua, Bhutan, Mozambique, Solomon Islands, Sri Lanka, Nauru, Malawi and Guyana are the countries which have accepted IP as the book of standard so far. Though India exports, mainly generics, to around 200 countries and one out of the three drugs consumed by a patient in any part of the globe is from India, IP is still not recognized by these countries. On the other hand, US Pharmacopoeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP) are accepted by all these countries. Medicines to the US, the UK and to the EU countries are supplied by India, but they are even now reluctant to recognize IP as a book of standard. If IP is accepted by more countries, it will be a huge relief for the exporters as it will help the pharma exporters, including the merchant exporters, to export their products to these countries without further retesting. There will be no requirement of applying a separate production method. Like the supply in the domestic market, medicines manufactured in IP can be bought and exported to the IP accepted countries which will treat them like their locally manufactured drugs. But, to the non-accepted countries, a separate method of production has to be followed in their quality and safety perspective as per each country’s pharmacopoeia.
There can be no two opinions about the fact that because of the proactive efforts of the Indian government, IP is getting greater acceptance in foreign countries. Of late, the Indian government has been taking several steps for acceptance of IP in more and more countries. Indian Pharmacopoeia Commission (IPC) had some time back submitted proposals to various countries to increase its efforts towards recognition and acceptance of IP in foreign countries. Besides, in 2022, the Union Health Ministry had released the 9th edition of IP containing 92 new monographs for drugs, 12 new general chapters, 1,245 monographs for formulations, 930 monographs for APIs as well as dissolution specifications for all prolonged release formulations. Several monographs and general chapters have also been revised to update them as per current global requirements and to harmonize with other pharmacopoeias like USP, BP, and EP. The harmonization of standards with global standards is expected to help IP getting recognized and accepted in foreign countries. Global recognition to the IP is crucial in boosting the credibility and competitiveness of Indian pharma products. The government should now leave no stones unturned to ensure that Indian pharmacopoeia is acknowledged and appreciated worldwide. Even though we have become ‘Pharmacy of the World’ by specialising in generic medicines and by supplying affordable medicine to the world, IP is still not accepted by the world. The Central government should now engage with other governments in the world for accepting IP as an international pharmacopoeial standard. The Indian government should be able to convince the countries in the world about the quality attributes of Indian drugs.
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