Karnataka government has notified that the director of Ayush would be the Controlling Authority for Ayush sector in the state. This led the Federation of Ayush Industry (FAI), formerly known as the Karnataka Indian Medicine Manufacturers Association, to withdraw the case which was pending before Karnataka High Court.
In the notification by the state government via No. HFW 310 PIM 2014, dated April 1, 2015, stated that under Section 33 G (4) of the Drugs & Cosmetics Act 1940, read with Rule 162 of the Drugs & Cosmetics Act 1945, the government appoints director of Ayush as the controlling authority with immediate effect.
In September 2014, the Karnataka government issued a notification assigning powers of Controlling Authority to the state drugs control department which will now be in-charge of the administration of the Directorate of Ayush licensing and sanctioning of prosecution during violations.
The notification issued via No. HFW 310PIM 2014 indicated that the Karnataka Drugs Control department, Bengaluru will be the ‘Controlling Authority for the purpose of chapter IV A of the Drugs & Cosmetics Act 1940 immediately. The drugs control department was to be responsible for the administration of licensing and consent to the prosecutions following violations in the drug quality standards. However, licenses were to be issued by the directorate of Ayush after the drugs control department cleared all applications with inspections to be conducted by their enforcement wing under its supervision.
The Karnataka Ayush industry has 215 Ayurveda, 10 Homoeopathy and 2 Unani units .
Objecting to the government move in December 2014, Ayurpark Healthcare and eight representatives of the Ayush industry in Karnataka filed a writ petition in the state High Court following the notification issued by the department of health and family welfare which appointed the drugs control department as the controlling authority under Rule 50(2) of the Drugs and Cosmetics Act.
The petitioners stated that Rule 50(2) is not applicable to the Ayurveda, Siddha and Unani (ASU) drugs . The said notification is against the operational guidelines of the National Ayush Mission for quality control of ASU drugs.
Ayush and allopathy are different systems of medicine and should be separately monitored with different regulatory authorities. It makes no sense to combine regulatory enforcement wing and its administration under the State drugs control department. In fact, it is a not a question of advantages and disadvantages following merger of the regulators. But the need of the hour is to strengthen the existing department of Ayush, said JSD Pani, president, Federation of Ayush Industry.
Following the government efforts to revert its stand on the issue, Pani said that this was the best that could have happened to the industry.