Karnataka Indian Medicine Manufacturers' Association (KIMMA) has raised serious objections to the selection of deputy director, Government Central Pharmacy, as the Drug Licensing Authority in the State Directorate of Ayush.

The Association has submitted detailed memorandum, in this regard, to various authorities in the State government including the Governor and the Principal Secretary, Karnataka department of Health and Family Welfare calling to withhold the orders which notifies the appointment of deputy director, Government Central Pharmacy as the Drug Licensing Authority.

According to J S D Pani, president, KIMMA, this appointment is not justified and it will attract a lot of objections from the industry and public. "This is because the selected deputy director is an herbal drug manufacturer and is also a licensee under the Drugs and Cosmetics Act," he added.

The qualification and experience for Drug Licensing Authority (Ayush) has been specified under Rule 162 A of the Drugs and Cosmetics Rules 1945. The Karnataka Director for the Directorate of Ayush in his proposal to the Principal Secretary of health and family welfare has clearly stated that Deputy Director, Government Central Pharmacy should not be notified as Drug Licensing Authority as was done earlier because Deputy Director (Government Central Pharmacy) designate himself is a drug manufacturer and holding license under the Drugs and Cosmetics Act 1940.

The director of Ayush has proposed the Principal, Government Ayurveda Medical College, Bangalore to be notified as Drug Licensing Authority as under Rule 152. The candidate also possesses the qualification and experience under Rule 162 A.

There are many more officers in the Government Ayurveda Medical College including Principal who are qualified under Rule 162 A of the Drugs and Cosmetics Rules for notification as Drug Licensing Authority. Moreover, the office of the principal and the college are adjacent to Drug Licensing Unit, whereas the office of the deputy director, Government Central Pharmacy is six kilometers away from the Drug Licensing Unit causing inconvenience to Drug Licensing unit staff and the drug manufacturers, stated Pani.

In case of any violations of the Drugs and Cosmetics Act observed by the Drug Inspector at the time of Inspection of Government Central Pharmacy, he needs to recommend for suitable action against the licensee to the Licensing Authority, which is not possible at all if the licensee and the licensing authority are one and the same. Hence, the order notifying the Deputy Director of Government Central Pharmacy as Drug Licensing Authority also amounts to violation of Drugs and Cosmetics Act 1940 and Rules, added Pani.