Policy Matter

Karnataka govt sets up exclusive Ayush Drug Licensing Authority to bolster inspection of mfg units, trade outlets

Karnataka government has set up a full time Ayush Drug Licensing Authority to strengthen inspections of the Ayurveda, Homoeopathy, Unani and Siddha medicine manufacturing and marketing activities in the state.Ayush-Drug

A notification via No. HFW 310 PIM, states that the government has now appointed an assistant drugs controller under Section 33 of the Drugs and Cosmetics Act 1940 and under Rule 152 of Drugs and Cosmetics Rules 1945.

The Ayush Drug Licensing Authority is now led by Dr HY Rathod who will report to the director of department of Ayush. There are five inspectors supporting Ayush Drug Licensing Authority: Dr. Naradamuni for Mysore division, Dr Shiv Kumar for Bengaluru, Dr Arun Kumar for Belgavi division,  Dr  Eshwar Kaolagi for Kalburgi division and Dr Jana Goud for Homoeopathy.

Establishment of a full time Ayush Drug Licensing Authority now enables the government to adhere to the Part XIV and XIX of the Drugs and Cosmetic Rules, according to the notification.

Further, the announcement is in suppression of the order No. HFW 202 PTD 1978, dated October 16, 1984 and HFW dated 658 PIM dated 2007 dated January 25, 2008.

“The state government has at last notified the regular full time Ayush Drug Licensing Authority, besides appointing five Ayush drugs inspectors. This will strengthen the regulatory mechanism in Karnataka. This is a significant achievement for the Karnataka Directorate of Ayush, said JSD Pani, president, Federation of Indian Ayush (FIA).

Last year, the Karnataka health and family welfare department had issued the notification No. HFW 310 PIM data September 17, 2014 appointing the drugs control department that inspects and approves only allopathic drugs as the controlling authority of Ayush. This was as per Section 33-G (4) which provides the government to appoint such an authority to whom the inspectors are appointed under Section 33-G (1) as subordinates.

But the 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 and their appeal was upheld.

According to Pani, the notification issued in September 2014 that as per Rule 50(2) of the Drugs & Cosmetics Rules this was not applicable to the Ayurveda Siddha Unani (ASU) drugs. Therefore the notification was viewed against the operational guidelines of the National Ayush Mission for quality control of ASU drugs. This led department of health and family welfare and concerned department revert to the earlier mode of administration.

In Karnataka,  there are 215 Ayurveda units, 10 Homoeopathy, 2 Unani units. There are seven approved Ayurveda, Siddha & Unani drug testing laboratories as per Rule -160 A to J of the D&C Rule 1945.

The leading Ayurveda players are–The Himalaya Drug Company, Natural Remedies, Maddur Pharma, Om Pharmaceuticals to mention a few.

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