After acting tough on the allopathic irrational combination drugs, the Union Health ministry has issued a notification asking the state licensing authorities (SLAs) to weed out irrational ayurveda, sidda and unani formulations in the country. The ministry has asked the SLAs to constitute an expert committee to screen the applications for new ayurveda, siddha and unani products in future.
"It has come to the notice of the central government that a large number of irrational ayurveda, siddha and unani formulations are being licensed for production by the state licensing authorities as Patent and Proprietary medicines. Further, these products are being licensed without insisting on the manufacturers providing testing protocols which can enable the regulatory authorities to get these products tested for their quality and safety.
"In view of the above, it has become expedient for the central government to issue a directive to the state licensing authorities under section 33P of the Drugs & Cosmetics Act, 1940 to streamline the system for licensing of Patent and Proprietary ayurveda, siddha and unani products under Rule 144 and 154-A of the Drugs & Cosmetics Rule, 1945," the notification said.
The ministry has asked 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. The expert committee will be headed by the Health Commissioner or director of the state.
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 ayurveda, sidda and unani medicines shall be made mandatory. Development of testing protocols for patent and proprietary medicine will be the responsibility of the manufacturers.
Application received from any ayurveda, siddha and unani manufacturers along with required documents should be submitted to the expert committee and the SLAs will take any decision on the application for issue of licenses on the basis of the advice of the expert committee only.
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. The state licensing authority, however, will be free to take a decision on the allocation if no reply is received from the department of Ayush within 60 days of the reference made to the department of Ayush.