The Union AYUSH Ministry’s recent directive to State governments to constitute expert committees to grant licences for patented and proprietary Ayurvedic drugs is expected to provide a fillip to the industry in Kerala.
No new licences had been issued for patented and proprietary Ayurvedic drugs in the State in the past five years because of the State government’s insistence on mandatory clinical trials. It was one among the reasons for the closure of a good number of small manufacturing units.
The government, however, lifted the provision on January 16, saying pilot studies supervised by an expert committee would be enough for granting licences.
Licensing process
In the order on February 12, the Deputy Drugs Controller in the Ministry pointed out that the expert panels, consisting of the senior-most Ayurveda officer in the office of the State Licensing Authority or Director, AYUSH; an expert on ‘dravyaguna’; an expert on ayurvedic pharmacy or ‘rasashasthra’; and an Ayurvedic drug inspector would streamline the licensing process.
They will have to examine the licence application and associated documents, proof of concept and testing protocols of the intended patent or proprietary drug as provided in Section 3 (h) (i) of the Drugs and Cosmetics Act, 1940, and the Rules under it.
Verification
They need to verify the reference of the proposed drug and its ingredients from authoritative books and ascertain that the excipients used in the formulation are in accordance with the provisions of the Rule 169 of the Drugs and Cosmetics Rules, 1945.
The expert panel will ascertain that the supporting evidence or proof of safety and effectiveness for the classical Ayurvedic drug with new dosage form or new indication and patent or proprietary drug is in accordance with the provisions of the Rule 158-B.
The committee should send in its advice and recommendations to the licensing authority within 15 days of the receipt of the application.
Expert panel
D. Ramanathan, general secretary, Ayurvedic Medicine Manufacturers Organisation of India, pointed out that the existing six-member expert panel was constituted in July, 2018.
The committee suggested by the State government in its order in January would not be effective now in the wake of the new Central order.
A new panel would have to be constituted and guidelines would have to be formulated for its functioning, Mr. Ramanathan added.
