PB, Bengaluru: European Pharmacopoeia and the European Medicine Agency have commenced the preparation of ‘Community Monographs’ for herbal remedies. To begin with, the monographs will be made applicable for single herbs.
The decision to create monographs is driven by the increasing shift in consumers opting for dietary supplements and nutraceuticals developed from herbs. The development of pharmacopoeia monographs would provide the much-needed information, stated Dr D B Anantha Narayana, leading scientist in herbal drugs and plant medicine.
Even the government of India through the Indian Pharmacopoeia or Ayurveda Pharmacopoeia needs to take up this. It would be the best way to ensure India gets its prominent position in the global herbal map. In an age of growing consumption of herbal nutraceuticals, there is need for authentic information on products, its usage, quality, dosage forms and disease indications, he added.
Pharmacopoeia monographs would serve not just for consumers but is important for physicians and pharmacists. US Pharmacopoeia (USP) is now primarily a regulatory quality specifications for all categories of drugs which can be extended to cover the ‘Dietary Supplements’.
Although, mere presence of a herb in a Pharmacopoeia does not mean it is approved as a drug, yet its importance cannot be underestimated. Pharmacopoeia monographs provide a reference globally for quality specifications for the authentic identity, content, component quality. It is an assurance that the product sans contaminants like microbial, pesticides and heavy metals. The very mention of a herb in the pharmacopoeia monograph allows easy trade and reduces rejections in the global market. It is also an indication to ensure batch-to-batch consistency for researchers. While the herb with a monograph can promote future technology developments, it provides regulators a confidence on the history of usage and safety profiles in the large scale production of a product, said Dr Narayana.
Globally, in the area of traditional knowledge based treatments, over 90 per cent of the products are botanical based. Despite the considerable discussions on need for standardization for herbal products, there has been a rise of use in herbal botanicals as supplements which do not come under the category of drugs. But the Pharmacopoeia experience coming handy has been largely to access the specifications of the herbs.
Indian Pharmacopoeia 2010 [IP2010] has 89 monographs for herbs, processed herbs, including for extracts/oils, and herbal products. USP has over 180 monographs for herbs, powdered herbs, processed herbs including extracts, oils, and herbal products. British Pharmacopoeia (BP) has over 50 monographs for herbs, powdered herbs, processed herbs including extracts, oils, and herbal products. European Pharmacopoeia (EP) has over 60 monographs for herbs, powdered herbs, processed herbs including extracts, oils, and herbal products. Pharmacopoeia of Republic of China [PRC] has over 180 monographs for herbs, powdered herbs, processed herbs including extracts, oils, and herbal products besides being the one that has quality specifications for large number of Traditional Chinese medicines (poly herbal).
With international regulators insisting now insisting on authentic herbs with defined botanical identity India will need to look at building a ‘Minimum Therapeutic Guarantee’ basis and establish a natural window of few compounds and test for the compliance to the window, pointed out Dr Narayana.