The Karnataka government has 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 licencing 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 for the state with immediate effect.

The Ayush department will not be merged with the drugs control department but will be responsible for the administration of licensing and consent to the prosecutions following violations in the drug quality standards. However, licences will be issued by the directorate of Ayush after we clear the applications and the inspections will be conducted by their enforcement wing under our supervision, Raghurama Bhandary, Karnataka drugs controller, told Pharmabiz.

The move would enable control of the quality standards of the Ayush drugs in the state. The directorate had been facing an acute shortage of inspectors to oversee the 215 Ayurveda units, 10 Homoeopathy and two Unani units.   It would help to keep tabs on the not-of-standard quality drugs and spurious herbal ingredients that are at times sourced by unwieldy small and tiny manufacturers, said sources.

Pharmabiz had reported that 27 years ago, the two departments worked in unison. The key reason to combine the two departments according to officials was to bring in more efficiency and transparency.  Now with the paucity of manpower, lack of required infrastructure and in an age of holistic medicine, the control of the directorate of Ayush by the state drugs control department is viewed to bring in speedy approvals.

JSD Pani, president of Karnataka Indian Medicine Manufacturers Association (KIMMA) who had been aggressively working to ensure that the control would not come under state drugs department said that prima facie the notification is against the uniformity of the central Act.

“It is against the provisions of the Chapter 4 A of the Drugs & Cosmetics Act and KIMMA hopes that the government of India will intervene and advice the state government on the need for consistency in administration. Under section 33 D of the National Policy & Programmes on Ayurveda, Yoga & Naturopathy, Unani, Siddha And Homoeopathy, a Drugs Consultative Committee needs to suggest to the Karnataka government to secure uniformity of administration, said Pani.

“In the light of the approval of the National Ayush Mission, by the central government on September 15, 2014, which also envisages better drug enforcement mechanism for Ayurveda Siddha, Unani and Homoeopathy drugs then the state government has gone against NAM objective”, KIMMA president said adding that he hopes the control by the state drugs department would not affect the sector’s growth prospects.