New volume of Ayurvedic Pharmacopoeia to cover 60 monographs of plant extracts

As one step ahead to keep quality standard norms for Ayurveda products in tune  with the present trends in the Indian ayurvedic medicines industry, the Ayurvedic  Pharmacopoeial Committee (APC) is coming up with the new volume of Ayurveda  Pharmacopoeia of India (API), Part I, exclusively comprising monographs of plant  extracts for the first time.The Committee has lately published the draft copy  of the new edition, the eighth volume of API, Part-I, with 60 monographs based  on upgraded monographs on 15 source plants, their powders, their aqueous and  hydro-alcoholic extracts, to ensure quality of these traditionally well known  medicinal plants for use as drug ingredients, according to sources from APC. The monographs included in the draft are Amalaki, Arjuna, Asvagandha, Bibhitaka,  Bhrngaraja, Brahmi, Haridra, Haritaki, Kalamegha, Kantakari, Mandukaparni,  Satavari, Tamalaki, Vasa and Yasti. The Part I of API consists of monographs  of single drugs even as the Part II consist monographs of compound formulations  in Ayurveda.The committee explains that the present trend of more manufacturers  shifting their traditional preparation like Vatis and Gutikas to compressed tablets  and capsules and attempts to adopt newer techniques of extraction, chemical preservation  and application of modern principles to achieve greater shelf life for ayurvedic  products has increased the importance of plant extracts. “A recent trend in ayurvedic manufacturing pharmacy aims at (1) enhancement of  potency and reduction in bulk of dosage form (2) convenience in administering doses  and (3) acceptability by improving palatability,” says the draft volume. “The trend, an  outcome of significant gains is knowledge in phyto-chemical contents of the source  plant and improved methods of assessing the pharmacological and therapeutic actions  of such phytochemical contents, has directly resulted in introduction of extracts of  plants as a more effective means of obtaining desirable results”, it added. The latest amendment in Drugs and Cosmetics Rule,2010  under 158 (B) clause IV issuing guidelines with respect to  medicinal plant extracts obtained from plants mentioned  in books of First Schedule of the Act including aqueous,  hydro-alcoholic and other than aqueous and hydro-alcoholic  extracts, also lead the committee to conclude that it is appropriate to prepare monographs on plant extracts and the standards for aqueous and hydro-alcoholic extracts are  presented for the first time, according to this, says the APC  in the draft. The work of preparing extracts using identical standard operating  procedures was allotted to three extract manufacturers – the  Bangalore-based Natural Remedies, Sami Labs and the  Vijayawada-based Chemeloids - and coordinated by Natural Remedies.Monographs on the fifteen plant drugs have been already included in earlier volumes of API Part I and they have now been upgraded to addition of Thin Layer Chromatography finger print profiling using Phyto-Chemical  Reference Standard (PRS). New addition of assay for the PRS has been also added to make the monograph comparable  to international standards. Monograph of an extract in the pharmacopoeia is to provide  qualitative and quantitative standards of quality for the extract for its use as a food item or a food supplement, dietary supplement or nutraceutical, as a drug or as an ingredient in cosmetics. Source:Pharmabiz