The Department of Ayush has once again asked the state licensing authorities (SLAs) to constitute an expert committee to screen the applications for new Ayurveda, Siddha and Unani (ASU) products in future. The Ayush department's new directive comes in the wake of complaints that some state ASU drugs controllers are issuing licenses to antacids and other products which are not Ayurveda drugs as per the norms.
"It has also come to the notice of the Department of Ayush that some antacids and other products have also been licensed as Ayurveda drugs in various states, even though they do not contain ayurvedic ingredients mentioned in various classical texts in the Schedule appended to Drugs and Cosmetics Act, 1940," the Ayush department directive to the SLAs said.
The Ayush department has been receiving complaints that some of the ASU drugs controllers are issuing licenses for manufacturing soaps, shampoos, hair tonic and tooth pastes as Ayurveda drugs. This practice has been prevalent for several years now. As these items come under the purview of cosmetics and not Ayurveda, complaints have started flowing to the department.
In fact, in order to weed out irrational Ayurveda drugs from the market, the Ayush department had earlier asked all the SLAs to constitute an expert committee as per the provisions of Rule 154 (2) for advising the SLAs before any patent and proprietary Ayurveda, Siddha and Unani medicine is licensed for production by any manufacturing unit. As per the new ministry directive, submission of 'proof of concept' and 'testing protocols' along with the application for obtaining license for any new patent and proprietary ASU medicines shall be made mandatory. Development of testing protocols for patent and proprietary medicine will be the responsibility of the manufacturers.
While some state authorities followed the directive of the Ayush department, a large number of the state are yet to constitute the committee.
As per the Ayush department directive, the expert committee would be headed by the Health Commissioner or director of the state. It would consist of experts in the field. In case of divergence of opinion either within the expert committee or between the expert committee and state licensing authority, the matter will be referred to the department of Ayush for advice.