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Sunday, 23 October 2016

IPC's herbal monograph manual to spur exports of plant extracts, bioactive products

Indian Pharmacopoeia Commission issued a guidance manual on herbal monograph which is expected to spur exports of plant extracts and bioactive products among others, said Dr DBA Narayana, pharma consultant.

Marker compound isolation and supply after due characterization are indicating huge demand globally both for standardization and screening for biological activity. Researchers engaged in clinical research to assess the health benefits of herbs are already looking for  IP grade material so that their studies are done with quality materials. Therefore, herbal monographs will increase India’s chances of exports of Ayurveda drugs, Dr Narayana who is also the chairman, herbals committee, IPC, told Pharmabiz.

“Both ministry health and ministry of commerce are promoting exports of Indian herbal products. This guidance manual on herbal monograph will further propel the exports prospects,” he added.

The industry has already been using some of these monographs as part of their quality control practices. In fact, IPC Committee accepted inputs provided by the industry to improve these monographs. For many herbs/processed herbs/herbal products for which monographs do not exist in IP, this manual will help the industry to develop quality specifications in an objective way. Since these monographs have been appreciated and accepted globally, it would reduce rejections due to differences in specifications of testing methods, noted Dr Narayana.

The manual lays down the processes for development. Hence new teams replacing the existing committee members can continue to work as per processes for the manual. Researchers can get tremendous guidance from the manual. It is hoped that the departments of pharmacognosy and phyto-chemistry of pharmacy colleges in the country will adopt the manual for future research. The guidance of herbal monographs can also give a fillip to start-up research companies.

In the global arena, India has shown its capability and leadership in the area of quality monograph development. Perhaps India has shown leadership in publication of the processes involved in such a highly scientific and regulatory led work, which can help many developing nations to follow suit. The excellence in creation of the manual is now enabling the Indian Pharmacopoeia Commission to provide its inputs to draft the Chapter on Good Pharmacopoeial Practices (GPP) for herbals being prepared by WHO. 

This guidance expected to stimulate more scientists to contribute monographs and also hone their skills and competencies in this area.  The challenge was to develop objectively assessable, reproducible and globally acceptable monographs for herbs. It was critical to distinguish between routine research on herbs with regulatory enforceable quality specifications and methods. Difficult steps were adopted for the development of  specifications like mandatory TLC profile, DNA barcode test for botanical identity, reproducing photograph of the plant covered in the monograph, publishing TLC atlas/chromatograms of assay, said Dr Narayana. 

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