The Indian Pharmacopoeia may lay down standards for herbal extracts for the first time to bring in quality levels for the products manufactured and exported from the country. The upcoming supplements or editions of Pharmacopoeia will cover many of the herbal extracts within next two years.
The Indian Pharmacopoeia Commission (IPC) will soon initiate efforts to include monographs of herbal extracts in supplement to the Indian Pharmacopoeia 2007. The Crude Drugs and Herbal Products Committee of IPC, in its meeting at Delhi in December 12, have decided to prepare a list of extracts to be included in the Pharmacopoeia. The committee will collect information from the industry and initiate the project after consulting with the Commission on the available resources including availability of funds.
"As of now, there is no minimum regulatory standard available for herbal extracts in the country. If IPC establishes a minimum standard for these products, the industry can follow the guideline for quality assurance," said Dr D B A Narayana, chairman of crude drugs and herbal products committee.
The market, especially the export market, demands specific standards for the products, and the industry is currently relying on their own standards in preparing herbal extracts. Once the IPC sets standards, it would cover all the areas including the standards of heavy metals, pesticides residue and the marker compounds, he added.
Though there is no published data on the size of herbal extracts market, experts say that the total exports market for the extracts will be more than Rs 1200 crore. Introducing minimum standards for the products would help the Indian companies to grab more market in foreign countries. "Moreover, the move may gain more importance even as the US Pharmacopoeia, the European Directorate for the Quality of Medicines (EDQM) and the British Pharmacopoeia have shown their interest to adopt herbal monographs from Indian Pharmacopoeia," averred Dr Narayana.
The committee has discussed the methods to set standards for herbal extracts, finished products and inclusion of additional herbs in the Pharmacopoeia edition. The experts are also considering how to introduce certain Ayurvedic properties of the respective herb while entering new herbal monographs, in order to help the Ayurvedic industry. However, a decision on this suggestion is yet to be taken, he maintained.