The ayurvedic drug manufacturers in the country have pleaded with the Union health ministry to classify the products that use hydroalcoholic extracts as new category called 'herbal medicine'.
The products that use hydroalcoholic extracts should not claim to be ayurvedic medicines or suggest in any manner by way of claims that they employ an ayurvedic rationale in any manner because there is no apparent reason except commonality of medicinal plants resource between their use by ASU sector and phyto-chemical industry. Phyto-chemicals represent a new drug phenomenon and not traditional medicine, the ayurvedic drug manufacturers argue with the ministry.
In a letter to the Ayush department, the Ayurvedic Drug Manufacturers Association (ADMA) said that the products that use hydroalcoholic extracts or wish to use in future, catering to a global demand for phyto-chemical products, need a regulatory pathway which is different and more tuned to the nature of the products which cannot be fitted into the definition of 'new drug' or 'new chemical entity' as defined in the Drugs & Cosmetics Act, 1940.
Criticising the Ayush department's recent notification (GSR No. 893(E)) which accepts the use of hydro-ethonolic as well as extracts derived from other solvents (other than aqueous and hydro ethonolic) in Ayurveda, the ADMA described it as 'one more attempt to regularise the use of solvents other than ones prescribed by Ayurveda and to redefine traditional medicine on phyto-chemical parameters, thus loosing its identity as a traditional medicine with millenniums of safe use'.
The Ayurvedic principles are clear of an approach in formulation and standardization and all efforts to update the same with the use of modern technology, without compromising the fundamental principals laid down in authoritative texts needs to be encouraged and taken forward. At all times, the identity of Ayurved as a traditional science should be insulated from deviations that would mar this distinct identity and heritage, the ADMA opined.
Appreciating the global opportunity for Phyto-Chemical products, the ADMA said that in the coming times many medicinal plants which have been extensively used in traditional medicine would be demanded globally. These medicinal plants would have to be standardised on their phyto-chemical profiles and delivery of such products would require extraction with various solvents and not just hydro-ethanolic. This opportunity however needs to be viewed separately and outside the definition and domain of Ayurved.
The ADMA suggested a definition for this new category of 'herbal medicine' as: 'herbal medicine' means - a herbal drug or combination thereof, which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals, intended for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, manufactured by innovative non-conventional processes, which is included in the edition of the Indian Pharmacopoeia or the authoritative books in the First Schedule.