The United States Pharmacopoeia (USP) may soon adopt a set of herbal monographs from India into it with the support from the Pharmaceutical Export Promotion Council (Pharmexcil) and the Indian Pharmacopoeia Committee (IPC).The US Pharmacopoeia's quality standards are recognized and used in more than 130 countries across the world.

The USP has already identified nine monographs eligible for adoption and is on the process of scrutinising more monographs from a set of 32 herbal monographs prepared by the IPC. A group of members of advisory on herbals, formed under a memorandum of understanding (MoU) between the USP and Pharmexcil, will support the process of adoption, according to sources.

"The USP has already seen around 15 to 20 monographs from the IPC and has agreed to select more than 50 per cent of them," said a member of the advisory group. The USP is expected to call for a meeting for discussion on the selected herbal monographs within two or three months. The discussion will be on the method of adoption, including the procedures, tests and the level of standards to be adopted etc.

Once the method is finalised, the adoption could be completed in six to nine months by preparing regulations, conducting tests and publishing draft of standards. The changes to be effected in the monograph while adoption should be controlled by the advisory board to make it sure that the standards are rational and objective, sources said. The procedure will be easy if the USP agrees to adopt the monographs with standards set by IPC.

The USP and Pharmexcil signed the MoU in February 2007 to bring in a synergy for setting quality standards for the pharmaceutical products, especially the herbal products and make the Indian products more acceptable to the growing quality driven market.

Meanwhile, more countries and standard setting authorities are showing their interest in adopting herbal database into their Pharmacopoeia. "Apart from USP, the British Pharmacopoeia is also interested in adopting herbal monographs from India. They have already listed 20 herbal monographs and is on the process of discussion with the Indian experts for adoption," added the source.

As Pharmabiz reported earlier, the European Directorate for the Quality of Medicines (EDQM) - the key European Organisation involved in regulation and quality control of medicines - is considering adoption of some of the Indian herbal monographs to the European Pharmacopoeia (EP). If materialised, the project will support an easy entrance for the standard-proven herbal products from India to around 36 member states of European Union.