Ayurvedic Pharmacopoeia Committee (APC) has appointed Natural Remedies and six other herbal companies to commence work on the ASU extracts for Ayurvedic Pharmacopoeia of India.
For this project, each company has been granted Rs.10 lakh for a period of one year. The other five companies which are part of the project are Kerala-based Arjuna Natural Products, Indore's Amsar Private Limited, Sanat Products Limited at Bulandshahar in Uttar Pradesh, Bangalore-based Green Chem and Chemiloids in Vijayawada, Andhra Pradesh.
The Ayurvedic Pharmacopoeia of India is ready and will be implemented from December 1, this year. The focus of the Ayurvedic Pharmacopoeia of India (API) was to develop 60 monographs on the 15 herbs selected for the project.
This is for the first time that solvent extracts were assessed for the 15 herbs. So long the previous Volumes covered only herbs per se, but this edition went ahead to be different, Dr Amit Agarwal, director, Human Health Products, Natural Remedies told Pharmabiz in an interaction.
While narrating the methodology adopted in this project, he added that of the 15 herbs selected for monograph development, each company was allotted five herbs and a common protocol for extraction. All the companies prepared water and hydro alcoholic extracts of these five plants and shared these extracts with other participating companies. Thus, three different batches of each extract were analysed by the participating laboratories/companies. Their findings were analysed and verified by the sub-committee of experts at APC. Only after ensuring that the results were found to be reproducible consent was given to convert the data into monographs for approval of APC.”
Four monographs were developed on each herb which covered the herb itself, herb in powder form, hydro-alcoholic extract and the water extract. Thin Layer Chromatography (TLC) was used to ascertain the identity along with High-Performance Liquid Chromatography (HPLC) for assay using phytochemical reference standards. "This is for the first time that the Ayurvedic Pharmacopoeia Committee has developed advanced monographs which by design and intention are on par with international standards including US Pharmacopoeia and British Pharmacopoeia,” said Dr Amit.
There are a couple of unique features of the API, Volume VIII. These include the incorporation of TLC and HPLC chromatograms within the monographs. Until now, the determination of shelf life/expiry date for all ASU drugs was governed by the gazette notification GSR764(E) dated October 15, 2009 as per which the shelf life was assigned to various dosage forms.
The ASU industry had been asking the Dept. of Ayush and its Drug Technical Advisory Board (DTAB) to issue official guidelines based on which interested manufacturers could undertake stability studies and determine the shelf life of their products based on those studies instead of being guided by a standard shelf life for a particular dosage form. The Ayurvedic Pharmacopoeia of India, Volume VIII, for the first time, has provided the protocol for scientific determination of shelf life/expiry date.