Many Ayurvedic preparations work / contain pre-probiotics . How would the regulatory authorities view proprietary Ayurvedic medicines?
Article Novel probiotics and prebiotics: Road to the market
Probiotics are the live micro-organisms that confer a health benefit on the host when administered in adequate amounts. Prebiotics are the selectively fermented ingredients that result in specific changes in the composition and/or activity of the gastrointestinal microbiota, thus conferring benefit(s) upon host health. A number of Ayurvedic medicines called Aasawa/Aaristha are prepared through fermentation may contain pre- and/or pro-biotics. Regulatory norms are in place by which commercial manufacturing of Ayurvedic medicines is regulated. Manufacturers have to take prior license from the State Drug Controlling Authority for running an Ayurvedic Pharmacy. Formulations whether classical or patent proprietary have to be got cleared from the competent authority before starting commercial manufacturing. Imposition of GMP through an amendment in the current licensing procedures has been implemented.
thanks Dr.Tripathi for the comprehensive answer!
My question is still how does the competent authority clear th preparation? what is the process (actual scientific method) by which the preparation is tested before certifying? the remaining is administrative checks and balances!
Dear Dr. P Ramesh, To my knowledge, for testing of ayurvedic drugs, there are testing laboratories set up by some of the state of India like Gujarat, Orissa, Uttarakhand and some others states . Govt of India will establishing an exclusive drug control department to facilitate testing of Ayurvedic drugs, Pl seethe following link
http://www.thehindu.com/sci-tech/health/exclusive-drug-controller-to-test-ayurvedic-medicines-harsh-vardhan/article6571201.ece
Protocols are defined for testing of Ayurvedic, Siddha and Unani drugs. Pl refer the attached file.
The ayurvedic medicines have to be standardized by the SOPs set by the CCRAS.
Regarding probiotic and prebiotic additives in Ayurvedic preparations, I would still think that it will take long time to reach a conclusion for its general presence. Few studies including mine suggests few instances of presence of potential probiotic microbes but I am not sure of regulatory norms concerning this aspect in India.
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