|
On January 2, 2026, the Indian Pharmacopoeia Commission (IPC) released the Indian Pharmacopoeia 2026 (IP-2026) which is the 10th edition of India’s official book of drug standards. IP-2026 contains a total of 121 new monographs including 88 drug substances, dosage forms, and pharmaceutical aids, 5 vitamins, minerals, amino acids, fatty acids etc, 2 biotechnology derived therapeutic products, 3 human vaccines, 2 blood related products, 20 blood and blood component monographs, and 1 veterinary vaccine monographs. In addition, 5 new general chapters have also been introduced. More importantly, 18 general chapters and 22 excipient monographs have also been revised to update them as per current global requirements and to harmonize with the Pharmacopoeial Discussion Group (PDG) pharmacopoeias like the European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), and United States Pharmacopoeia (USP). Definitely, this harmonization of standards with global standards is expected to help IP getting recognized and accepted in foreign countries. The earlier 9th edition of the IP-2022 had introduced a total number of 3152 monographs, which included 92 new monographs of APIs, dosage forms and vitamins, 12 new general chapters, and categories for biotechnology-derived products, vaccines, and herbal products. Now, the 10th edition of the IP has introduced a total of 3340 quality standards for medicines with new blood, blood components and excipient quality standards to ensure safe and efficacious medicines for patient safety in India. IPC’s sustained efforts in strengthening pharmacopoeial standards and pharmacovigilance activities are surely promoting self-reliance, scientific excellence, and robust healthcare standards in the country.
No doubt, the IPC has done a good job in adding more and more monographs periodically as it will go a long way in getting acceptance for IP in more countries. That the IPC’s initiative is bearing fruit is clear from the fact that the Indian Pharmacopoeia is now recognised in 19 countries, reflecting the growing international confidence in India’s regulatory and scientific capabilities. Of course, this recognition of IP by more and more countries in strengthening India’s position as the Pharmacy of the World and underscores the credibility of Indian pharmacopoeial standards globally. In fact, 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, United States Pharmacopoeia, BP and European Pharmacopoeia 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 Indian Pharmacopoeia as a book of standard. As the Indian Pharmacopoeia Commission is doing its job well, it is now over to the Indian government to further intensify its efforts to widen the Indian Pharmacopoeia net in the entire world.
|