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WIDEN THE IP NET

Ramesh Shankar
Wednesday, September 18, 2024, 08:00 Hrs  [IST]

Recently, the merchant exporters in the country have called for a collaborative approach involving the Indian Pharmacopoeia Commission and the Union ministries of Health, External Affairs and Commerce & Industry to promote global acceptance of Indian Pharmacopoeia (IP) approved products. The merchant exporters have demanded formation of a joint task force, comprising representatives from these bodies, to work together to promote the acceptance of IP approved products in smaller countries. It is a fact that exporters are facing challenges in exporting IP approved products due to their lack of acceptance in many countries. Several countries still do not accept IP approved products, making it difficult to export products in small quantities. The primary issue lies in the batch sizes, which do not align with the requirements of these countries, creating barriers for Indian exporters. This situation hinders the export of products in small quantities, as batch sizes do not meet the requirements of these countries. So, there is a need for concerted efforts by a joint task force to address these challenges and promote the acceptance of IP products globally. This joint task force should communicate with various trade bodies such as the Caribbean Community (CARICOM) and the East African Community (EAC), to name only a few, to advocate for the acceptance of IP standards. This effort would involve highlighting the quality and safety of IP approved products and addressing any concerns or misconceptions these countries may have about the IP approved products. There is a need for uniform acceptance of IP approved products to streamline the export process. This would enable them to meet the demands of smaller countries without having to alter batch sizes, thereby reducing costs and increasing efficiency.

Of late, the Indian government has been taking several steps for acceptance of IP in more and more countries. 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 US Pharmacopoeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), etc. But, it is unfortunate that 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 six countries have so far accepted IP as a book of standards. 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. If IP is accepted by more and more country, 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. So, the government should pay heed to the demand of the merchant exporters and form a joint task force to advocate for the acceptance of IP approved products.

 

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