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Tuesday, February 27, 2018

Karnataka Ayush sector asks govt to provide clarity on new regulatory structure at CDSCO for drug approvals

The Karnataka Ayush sector sees that its new regulatory structure at the CDSCO to monitor Ayurveda, Siddha and Unani drugs need more clarity. While the industry in general appreciates the move, yet there are apprehensions on its implementation.

According to Dr DBA Narayana, chief scientific officer, Ayurvidye Trust and pharma consultant, this announcement of an exclusive regulatory structure at CDSCO for Ayush is the first step of long-term intent to unify and have one drugs controller or have only one powerful drugs controller machinery. The current order, while its intent may be good, requires a preamble to state its purpose and the future road map.

This is no doubt a step in the right direction and gives a booster shot to the Ayush sector taking it to the next level in the international market, he added.

"It is early for the industry in particular to comment on the development, as we are not aware what delegate powers are given to the new Ayush officials under DCGI. We hope that the new officers help the smooth implementation of the concerned regulations under the D&C Act, and hence facilitate the growth of Ayush sector,” Dr Vijendra Prakash, general manager - regulatory, corporate affairs, The Himalaya Drug Company told Pharmabiz in an email.

Industry observers stated that the announcement of exclusive regulatory structure at CDSCO for Ayush does not provide any details on the future role of the state licensing authorities. Now the National Medical Commission bill is here to regulate ayurvedic education and practise. But we are wondering how the Ayush drug monitoring will be separated and placed under one CDSCO where they will need a deputy or joint drugs controller with the expertise in Ayurveda, Siddha Yoga, Unani and Homoeopathy.

In allopathy, the regulation is by both the state and the central authorities. If this leads to a separate Central Drug Control Authority for Ayush drugs may not have a legal sanctity unless the Act is amended, said JSD Pani, president, Karnataka Indian Medicine Manufacturers Association.

It is a good move that they are going to recruit qualified personnel to handle the regulatory aspects and till such time the technical personnel in the Ayush Ministry will be handling it.

This seems to be okay for ASU drugs but for Homoeopathy I don’t find any technical officer in Ayush ministry having qualification under Rule 49 to notify as Inspector and Rule 49a as drug Licensing Authority, he added.

It is not clear about the functioning of these new posts created. We are keen to know if it is a parallel system to State Regulatory Authority or the supportive to regulatory is not known. There is a lack of comprehension as to what extra powers, the officers get by getting designations like, additional drugs controller, joint drugs controller, deputy drugs controller, assistant drugs controller among others, said Pani.

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Item Reviewed: Karnataka Ayush sector asks govt to provide clarity on new regulatory structure at CDSCO for drug approvals Rating: 5 Reviewed By: Ameer CT