Pharmaceutical Industry across the globe is making a shift in search of entities from synthetic active constituents towards substances which are of natural origin.

                Safety being prime concern, herbal drugs are back in vogue. Ayurvedic medicines known to treat & prevent various diseases since eons are now being re-validated for Safety, Efficacy & Quality.

                Regulatory bodies in India like Department of Ayush in association with Ayurvedic Pharmacopeia Committee (APC) has taken the initiative for standardization of crude herbal drug & published monographs in compendium of API Part-I (Vol. 1 to Vol. 8). Similar initiatives have been followed by various committees/ associations like AHPA (American Herbal Products Association), BP(British Pharmacopoeia), USP(United States Pharmacopoeia), IPC( Indian Pharmacopoeia committee), ICMR( Indian Council of Medical Research). BIS (Bureau of Indian Standards) is also working to issue monographs of Herbs.

                Whilst such monographs are in publication, the specifications of these drugs are not uniform across these compendia. It is known fact that there may be variations in the methods applied across the countries while analyzing these drugs.

                A case study of Ashwagandha (Withania somnifera) monographs was carried out (Table 1). Variation in parameters defined in each compendia and variation in specification can be noticed here.

With more and more monographs being added in various pharmacopeias, who should take the initiative to harmonize these standards?

An important observation is that within India there are atleast 4 different committee’s working simultaneously for publication of Monographs. Will it create a bias in the mind of user? 

Looking to our Heritage and Wisdom of Ayurvedic Medicines, major contribution should be ideally in the hands of agencies like Ayush & APC with collaborative technical support from IPC,ICMR &BIS. 

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