The ayurveda, sidha, unani drug manufacturers in the country are concerned over the Union health ministry's decision to constitute an expert committee in each state to screen the applications for licences for new ayurveda, sidha and unani products in future. The health ministry had recently issued a notification in this regard.
Expressing concern over the health ministry's move, Ayurvedic Drug Manufacturers Association (ADMA) general secretary Ranjith Puranik said that the ministry's move will only further delay the entire licensing process. "There is concern among the manufacturers about the delay in licensing process. In fact, reports of such delays have already started pouring in from different states", Puranik said.
With the formation of Central Drug Authority (CDA) very much on the anvil, the formation of such committees at this stage is sheer waste of time and nobody will benefit from this. With the implementation of this scheme and the subsequent formation of expert committees, there will be difference of opinion on the efficacy and quality of drugs. "There could be endless debates and all these will help delay the entire process", Puranik said.
However, the ADMA is yet to convey its concerns to the health ministry in writing. The ADMA was hopeful that the health ministry will review the notification. In fact, there was talk about the review of the notification in the wake reports that the industry is not happy with the proposal.
In order to weed out irrational ayurveda, sidha and unani formulations in the country, the health ministry had recently issued a notification asking the state licensing authorities (SLAs) to constitute an expert committee to screen the applications for new ayurveda, sidha and unani products in future.
The health ministry's action came in the backdrop of complaints that a large number of irrational ayurveda, sidha and unani formulations are being licensed for production by the SLAs 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.
The ministry asked the SLAs to constitute an expert committee, headed by the Health Commissioner or director of the state, as per the provisions of Rule 154 (2) for advising the SLAs before any patent and proprietary ayurveda, sidha and unani medicine is licensed for production by any manufacturing unit.