To bring in more efficiency and transparency, the Karnataka government will soon merge the state department of Ayush with the state drugs control department. The order is expected to be issued early next week. So long, the department of Ayush was a separate entity with a dedicated workforce under the state directorate of health and family welfare.
The move which is a first in the country will bring the regulatory enforcement wing covering issue of manufacturing and marketing licenses for Ayurveda, Homeopathy, Unani and Siddha drugs under the purview of the state drugs control department which focusses on modern medicine or allopathy drugs.
Around 27 years ago, the two departments worked in unison. The key reason to combine the two departments according to officials is to bring in more efficiency and transparency.
Confirming that the state government was contemplating on the merger of the Ayush with the state drugs control department, Raghurama Bhandary, Karnataka drugs controller said that the effort to combine all drug licencing approvals and administration under one umbrella was the need of the hour. It would be easy to monitor every drug manufacturing and sale licensing in the state.
“We would look at training our enforcement teams in Ayush licencing norms. In terms of infrastructure and ease of administrative control, our department was way ahead primarily because of computerisation and networking. It will be far more convenient for the Ayush manufacturing units to seek licenses and clearances for new units. Moreover, our inspectors were well conversant with the good manufacturing practices, good lab practices and also in detecting suspicious spurious drugs in the supply chain”, he added.
Now with the paucity of manpower, lack of required infrastructure and in an age of holistic medicine, the merging of the department is viewed by experts to bring in speedy approvals.
Karnataka minister for health and family welfare UT Khader confirmed that the there would be only one regulatory authority for both Ayush and allopathy. Therefore, the state drugs control department would be made responsible for issues of licenses for Ayush drugs and the administration of the department. However, Vijaykumar Gogi, director, Karnataka department of Ayush refused to comment.
Pharmabiz had gathered that the total shortfall of personnel is 20 per cent in the Ayush department, colleges and hospitals. However, certain sections of the Ayush depicted almost 50 per cent paucity of personnel. The department had been devising ways to utilise the existing infrastructure by deploying the qualified human resources.
Currently, the D&C Act features Ayush manufacture and licensing norms under Chapter 4. Last year, 10,000 units of the Indian Ayush sector were demanding for a separate Act. A Parliamentary committee was formed to bring out a draft on the same. Now the industry is surprised at the move in Karnataka.
In Karnataka there are 215 Ayurveda units, 10 Homeopathy and 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.
Criticising merger of Department of Ayush with allopathy a section of the small industry feared that closure of units would be imminent. They argued that inspecting an Ayush unit was a different ball game and could not be handled by the drugs control department.
An industry expert who appreciated the move pointed out that it was the vaidyas who propounded pharmacology of herbs. However, had no suggestions on quality control standards, microbial contamination of herbs, heavy metal content or the modern scientific methods of analysis. If the Ayush department came under the purview of drugs control department, then there would be increased focus on quality standards enabling higher export earnings, he noted.