The government of India is drafting a notification according to which drugs manufactured by traditional systems of medicines would have to go through the same process of drug testing and trials as required for allopathic drugs.
The guidelines issued in June by the Ministry of Health are to be followed for all new medicines manufactured by traditional systems like Ayurveda, Siddha and Unani for patent proprietary, at different stages of drug development.
If the guidelines are notified, a company which wants to market a drug prepared by alternative system, it would have to support the drug claims with data generated by tests and trials according to the norms laid by the government.
Janardan Pandey, joint advisor, Ayurveda, department of Ayush under the Ministry of Health and Family Welfare feels that the move has been initiated because today the acceptance of modern science is only for evidence based medicines. “International stress in on the evidence based medicines, today,” he said. If a company desires to export the ayurvedic medicines, the importing country wants the evidance for quality and efficacy of the medicine, he added.
However, the companies which manufacture traditional medicines believes that though tests are required but having a generalised approach towards all systems of medicines would not work. Ranjit Puranik, CEO of Mumbai based Ayurvedic drug making company, Shree Dhootapapeshwar Ltd said, “According to the ancient ayurvedic texts, the very basis of this traditional system is gundharma, which means rational use of ingredients and dosage. The claims in Ayurveda are based on results.” So, the notification guidelines seem very amateurish. It is a feeble and baseless attempt to ape the western practices without understanding the basic nature of Ayurveda.
However, GC Gaur, technical officer, department of Ayush said, “These are just draft guidelines of the notifications which are subject to change.”
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