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THE IP AND ITS ACCEPTANCE

Ramesh Shankar
Wednesday, April 17, 2024, 08:00 Hrs  [IST]

Nicaragua has become the sixth country, after Afghanistan, Ghana, Nepal, Mauritius and Suriname, to officially recognize Indian Pharmacopoeia (IP) as a book of standard.  Recently, an MoU was signed on Pharmacopoeia Cooperation between the governments of India and Nicaragua. Certainly, Nicaragua's recognition of the IP adds another accolade to its global reputation and acceptance. But, it is unfortunate that though India is the world's largest supplier of generic medicines and accounts for 20% of the worldwide supply of generics by volume, only six countries, including Nicaragua, have so far accepted IP as a book of standards. 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 and 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 retesting them. For the merchant exporters, the medicinal products in IP can be exported to overseas markets without further testing. There is 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.

It is a fact that the Indian government has of late been taking several steps for acceptance of IP in more and more countries. But, the result has not been that much encouraging. 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. Earlier 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. There are no two opinions about the fact that because of the proactive efforts of the government, the IP is getting greater acceptance in foreign countries which is clear from the fact that the IPC has now become a member of the Pharmacopoeial Discussion Group (PDG). PDG consists of Pharmacopoeia Commissions from US, Europe and Japan as members to harmonise pharmacopeial standards globally with the WHO as the observer. Earlier last year, IPC was selected by PDG for its year-long pilot for global expansion. IPC was the only pharmacopoeia body in the world to be selected for pilot phase of global expansion initiated in September 2022. Inclusion of IPC in PDG will definitely increase the visibility of the IP on international platform. It will establish IP as progressive pharmacopoeia which designs drug quality standards at par with global standards. But still, the fact remains that though we have become ‘Pharmacy of the World’ by specialising in generic drugs, and by supplying affordable medicine to the world, IP is still not accepted by the world. For that, the government has to walk the proverbial extra mile.

 
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