Despite the notification issued by Department of Indian Systems of Medicines (ISM) prescribing specified qualification for officers assigned for licensing Ayurvedic drug manufacturing units in the state drug control departments, the Central Department now seems bewildered on the same. While commenting on the enforcement status of the notification, S K Sharma, Advisor (Ayurveda), Department of ISM, said that the government is not very clear about the impact of the same, so that it may or may not proceed further on it.

Nevertheless, the Centre's directive (GSR 76 (E)) under which the qualification for the State Drugs Licensing Authority for licensing of Ayurveda drugs has been prescribed as B Pharm in Ayurveda or BAMS, on February 3, 2003, is still not been considered by the state governments as well.

Talking to www.pharmabiz.com, Sharma said “I cannot comment anything about the implementation part of the Notification as I am not aware how serious is the government to go about it.” As far as the directive is concerned it remains unchanged as on today, and it may change as well if the government want to do so, he added.

Following the central government Notification to the State Drug Control departments in Maharashtra, Gujarat, Kerala, West Bengal and Tamil Nadu, the All India Drug Control Officers' Confederation (AIDCOC) had protested the same citing that while issuing the draft rules on the subject under G.S.R. 607 (E) dated 20/8/2002, the Government of India has overlooked the fact that the licensing authorities for licensing of Ayurveda, Siddha and Unani drugs in the State of Maharashtra, Gujarat, Kerala, West Bengal and Tamil Nadu do not posses the proposed qualification. While finalizing these draft rules, the comments received from FDCA, Gujarat, FDA Maharashtra and All India Drugs Control Officers' Confederation have not been taken into consideration.

According to S W Deshpande, secretary general, AIDCOC, logically and practically speaking the qualification of the licensing authority should be consistent with the qualification of the drugs inspector prescribed under Rule 167 of the Drugs and Cosmetics Rules, 1945. “Since this Rule prescribes the qualification of inspectors as a person who is appointed an Inspector under section 33G shall be a person who has the qualification laid down under Rule 49 and shall have undergone practical training in the manufacture of Ayurvedic drugs, in these five states an integrated approach has been adopted and licensing and implementation as regards allopathic and Ayurvedic drugs is done through one agency such as FDA Maharashtra, FDCA Gujarat etc.

He said that in these states, the Drugs Inspectors appointed under section 21 having qualification prescribed under Rule 49 have been duly trained and then appointed as Inspectors under Section 33G of the Act. “Obviously, in view of the hierarchy and the recruitment rules, such Drugs Inspectors on promotion to the post of Joint Commissioner or Commissioner or Director have been appointed as the licencing authority for the purpose of licensing of Ayurvedic drugs. Therefore, these licensing authorities have qualification prescribed under rule 49 and most of them are graduates or post graduate in Pharmacy,” he says.

Elaborating on the real impacts of introducing new parameters for appointing licensing officers, Deshpande informed that if the notification no. 76(E) is to be implemented, all these authorities in the above said five states will become ineligible and will have to be immediately replaced by another person who may not be having sufficient experience and knowledge of licensing and the implementation. This is bound to adversely affect the quality monitoring exercise as regards Ayurvedic Drugs. In State of Maharashtra, licensing as regards manufacturing is delegated to the divisional Joint Commissioners and therefore, the Government will have to appoint seven additional persons as the Licensing Authority for each division, which will be unnecessary additional cost or the Government will have to take a retrograde step of centralization.

The AIDCOC had in March 2003, soon after the Notification, had requested the Secretary, Dept of ISM, that to stay the operation of the notification no. 76(E) and issue suitable instructions to all concerned immediately. And the Confederation had also requested the Department to give it a personal hearing so as to enable them to explain the issues related to implementation and necessity to have integrated approach and keep the job of implementation and licensing authority with the Drugs Control Administration in the Country to ensure uniformity and effective implementation of the provisions related to manufacture, sale and distribution of Ayurvedic Drugs.

However, when asked about the AIDCOC plea to re-examine the revision of qualification for licensing authority for Ayurvedic, Unani and Siddha drugs, the Advisor, Dept of ISM (Ayurveda), said that he is not aware about the same and there has been no serious discussion over the issue held at the Department after the notification was issued in February.