Stringent regulations halt research on Ayurvedic drug

New proprietary drugs have stopped coming into the market after government-mandated clinical trials for Ayurvedic medicines. Even drug control authorities do not have clarity about the clinical trial procedures for Ayurveda.

Before 2010, when the central government introduced Allopathy-modeled clinical trials for Ayurveda, the companies had to present documented research about the new product and its efficacy before the state-level drug controller to get a license.

After the new regulation, no Ayurvedic company has got any new proprietary drug licensed and very few have undertaken the clinical trial procedures. Even in a state like Kerala more than 50 proprietary products used to get licenses prior to 2010. The new procedures are very complicated and unclear. The Ayurvedic industry is stuck due to the new regulations.

Under the Drugs and Cosmetics Act, the central government had mandated that ingredients of herbal, mineral and animal origin mentioned in the 56 authenticated texts of Ayurveda only should be used for product development. These ancient texts only mention limited number of such ingredients available on earth that can potentially be used to prepare an Ayurvedic drug. If permission is granted to include other herbs and ingredients, it will advance the cause of herbal medicine and science in general and patents in particular.

In modern medicine, drug companies come out with new molecules, but in Ayurveda it is mostly in the form of formulations. The clinical trials should also be conducted only in the limited number of Ayurvedic colleges in the country. Unfortunately, the personnel in these colleges do not have any clue on how to go about with clinical trials. Financial constraints too are holding back the Ayurvedic houses in the country. There are about 9,000 Ayurvedic drug manufacturers of which 8,500 are micro and tiny. Small and medium account for about 100 and only very few companies have the wherewithal to conduct clinical trials, the cost of which can run into crores of rupees. Once a company goes through the trial and launches a product, the patent systems too are not clear for Ayurvedic products so that they have exclusive rights to market it for seven to 10 years and recover the cost on trials and production.

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