Notwithstanding the industry's opposition, the union health ministry has decided not to review its notification issued recently to weed out irrational ayurveda, sidha and unani formulations in the country. The ministry has given green signal to the state drug departments for the formation of expert committees in each state to screen the applications for new ayurveda, sidha and unani products in future.
In fact, the department of Ayush has invoked section 33(p) of Drugs & Cosmetics Act, 1940 and has given directive to the state licensing authorities (SLAs) to streamline the system for licensing of patent and proprietary ayurveda, sidha and unani products under Rule 144 and 154-A of the Drugs & Cosmetics Rule, 1945.
"The department is not reviewing the notification as is being made out by some people. We have given instructions to the SLAs to constitute expert committees. In fact, such committees have come up in several states", a senior official in the department of Ayush said.
Allaying fears of the industry, the official said that the formation of expert committees will go a long way in ensuring quality.
The department of Ayush issued the notification around two months back when it came to the notice of the central government that a large number of irrational ayurveda, sidha and unani formulations are being licensed for production by the SLAs as patent and proprietary medicines. Besides, it came to the government notice that 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 the notification, the ministry asked the SLAs to constitute an expert committee for advising the SLAs before any medicine is licensed for production by any manufacturing unit. As per the directive, submission of 'proof of concept' and 'testing protocols' along with the application for obtaining license for any new patent and proprietary ayurveda, sidha 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, sidha and unani manufacturer 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.