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The efforts of the Indian Pharmacopoeia Commission (IPC) to get the Indian Pharmacopoeia (IP), which proves the standards of Indian made drugs, recognized and accepted by foreign countries will be supported by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) as the council feels that promotion of IP worldwide will help increase the country’s pharmaceutical exports.
“Pharmexcil will work together with the IPC in that endeavour because IP has been accepted by only four countries as a book of standards and it needs to be accepted by more. IP promotion is also a responsibility of the council,” says SV Veeramani, vice-chairman of the Pharmexcil.
According to him, efforts are being made by the council to get the IP accepted by all the countries in the world one by one. Currently, countries such as Afghanistan, Ghana, Nepal and Mauritius only have accepted the Indian Pharmacopoeia as a book of standard to ensure drug quality. Among these, Afghanistan is the first country that accepted the IP by their national ministry of public health.
He said it is high time other countries recognized our IP as a book of quality standards as India has already become the ‘pharmacy of the world’. India exports, mainly generics, to more than 250 countries and one out of the three drugs consumed by a patient in any part of the globe is from India. But, Indian Pharmacopoeia is not recognized by these countries. Whereas, the US Pharmacopoeia (USP), the British Pharmacopoeia (BP) and the Pharmacopoeia of the European Union (EP) are accepted by all the countries. Medicines to the USA, UK and to the EU countries are supplied by India, but they are reluctant to recognize IP. Veeramani said the IPC and the Pharmexcil, through the government of India, are taking steps with other countries for acceptance of IP. He pointed out that the forthcoming international regulators’ meeting in New Delhi in September would also take this issue as an agenda for discussion.
Talking about the advantages of recognition of IP by foreign countries, the industry doyen said acceptance of Indian pharmacopoeia by foreign countries will help the merchant exporters to do their business easily. The medicinal products in IP can be exported to overseas markets as they are. There is no need to apply 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 done in their quality and safety perspectives as per each country’s pharmacopoeia.
“The superiority complex of the western countries is the major hurdle in accepting the IP by them. Our medicines are acceptable for them, but standards cannot be accepted. That poses a paradox. However, Pharmexcil is taking all efforts to get the IP accepted by all countries and we hope that it will happen in a gradual manner,” Veermani told Pharmabiz.
On the second of this Month, the Indian Pharmacopoeia Commission released the 9th edition of the IP which contained 92 new monographs for drugs, 12 new general chapters, 1,245 monographs for formulations, 930 monographs for active pharmaceutical ingredients (APIs).
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