The Ayurveda, Siddha, Unani (ASU) industry vehemently opposes to the provisions enlisted in the draft guidelines regarding good clinical practices and clinical trials of ASU drugs, stressing that if implemented it will have strong implications on the growth prospects of the industry. They are also worried over the government’s inability and lack of interest in involving the stakeholders opinion while framing such rules for the industry.
The latest circular from the Department of Ayush mandates for clinical trials for all the existing and new ayurvedic medicinal products under the proprietary and patented criteria. Sources inform that the Department is contemplating to implement this draft guidelines from April onwards, which unfortunately will pose a great problem.
Expressing concern over the future of the traditional medicines in the country, an industry insider pointed out, “There is no need for clinical trials for traditional medicines especially for the ones that are already well established in the market from years, since their active profile is already known and used in traditional medicines from centuries. The government would have understood this if that they had a better understanding of ASU sector. Unfortunately for us neither do they have any background information of the industry which they are representing nor do they involve the stakeholders in any of their meetings to guide them.”
Industry is afraid that if this guideline gets implemented it will have a huge impact on around 7000 small and medium scale manufacturers across the country who do not have enough resources to invest on clinical trials. Experts from the industry said that the Department of Ayush which is supposed to address the problems of the industry is only adding its trouble by drafting such anti industry guidelines. “On top of that they are not even ready to involve the stakeholders in any of their decision making discussions while drafting these guidelines,” he stressed.
He said, “The industry is not against any progressive or positive ideas that promises to benefit the sector, but what the government is trying do through this guidelines is anything but that. This draft guidelines is an example of their lack of interest in helping the industry towards growth. This is a very complicated issue affecting an industry at large thus rather than making a rash decision the Government should consider taking a calibrated approach towards this issue after requisite discussions and deliberation with the stakeholders.”
Many in the industry claim that the Department of Ayush has hardly put any efforts to understand the needs of this unique industry and has simply mimicked the new molecule guidelines for modern medicines while framing the guidelines for traditional medicines.
It is understood that ADMA and other associations representing traditional medicines in the country are in the process of submitting representation to the Department soon demanding them to change some features in the present guidelines before implementing it.