|
Botswana has become the 18th country to recognize Indian Pharmacopoeia (IP) as a book of standard for medicines when it signed an MoU with the Indian government during Indian President Droupadi Murmu’s recent visit to Botswana. This MoU will establish a framework for the recognition of the IP as a pharmacopoeia standard for assessing applications for market authorisation for medicinal products manufactured in India. Thus, it will significantly ease regulatory procedures and facilitate greater market access for Indian pharmaceutical products in Botswana. This growing recognition of IP reflects the growing international trust in India's robust scientific and regulatory frameworks. This recognition is expected to boost India's pharmaceutical exports to Botswana by removing the need for duplicate testing and post-importation checks. Global recognition to IP as a book of standard has been a major issue the Indian pharmaceutical 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 generic drugs by volume, very few countries accepted IP as a book of standard till early this year. But, things are now changing fast as the acceptance of IP is gathering momentum, thanks to the proactive measures of the Indian government which has been taking several steps for acceptance of IP in more and more countries. In this regard, the 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. In 2022, IPC had released the 9th edition of IP containing 92 new monographs for drugs, 12 new general chapters, 1245 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 US Pharmacopoeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), etc.
The result is there for everybody to see as a total of 18 countries have now accepted IP as a book of standard. The IPC signed its first IP recognition MoU with Afghanistan in 2019, making it the first country to officially recognize IP. The MoUs on pharmacopoeial cooperation has earlier been signed with countries like Ghana, Nepal, Mauritius, Suriname, Nicaragua, Bhutan, Mozambique, Solomon Islands, Sri Lanka, Nauru, Malawi, Guyana, Fiji, Cuba, Maldives, Trinidad and Tobago. These MoUs established the IP as the recognized compendium of standards for medicines in these countries. Recognition of IP by more countries will be a huge relief for the exporters as it will help the pharma exporters to export their products to these countries without 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 according to their quality and safety perspective as per each country’s pharmacopoeia. It is strange that 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, USP, BP and 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. The Indian government should further intensify its efforts to widen the IP net in the entire world.
|