The Karnataka Ayush industry with its 215 Ayurveda units, 10 Homoeopathy and 2 Unani units are now apprehensive about the possible merger with the State drugs control department that is responsible for the approval of allopathy 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 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, Karnataka Indian Medicine Manufacturers Association (KIMMA).
Pani further pointed out that he was in discussion with the Karnataka government to defer the merger. In this regard, he had called upon State health minister UT Khader and highlighted that proposed notification to merge the two departments needed a legislation. This was because the Drugs & Cosmetics Act Chapter 4 was dedicated for Ayush and therefore the move to merge would require clearance from the State law department.
“We believe that the Ayush and FDA should function as autonomous bodies. Their roles and responsibilities are very different as also the qualifications required to their members. Most states in India have set up independent regulatory bodies to govern Ayush and allopathy drugs, in recognition of the fact that these are two different systems of medicine, requiring different sets of expertise. In our opinion, efforts must be made to strengthen the Ayush at the state and national level, giving it the support needed to promote traditional systems of medicine in India and overseas”, said Dr.Vijendra Prakash, senior manager, Domestic Regulatory Affairs, The Himalaya Drug Company.
According to Dr. Chitra Phadnis, chief executive officer, Madhur Pharma which is primarily engaged on contract manufacture of herbal formulations, in the event of a possible merger of Ayush with the state drugs control department the big fear is that the Indian System of Medicine would lose its identity.
The effort to merge is seen to be a serious blow to the Ayush industry which has invested time and funds to bring up the sector to be recognised as a quality herbal supplier in the global markets and also as dependable contract manufacturer, said Dr. Phadnis adding that apprehensions prevailed that the image of Indian System of Medicine would take a beating.
Airing similar views with the industry was Dr. K Venketesh, Ayur pharma consultant who said that there are differences in the regulatory mechanism and approval of quality standards in Ayush. The audit of herbal, Homoeopathy, Unani and Siddha production plants needed a different mindset with knowledgeable and qualified personnel from Ayush mainstream.
Dr. Venketesh stated that the Ayurveda Pharmacopeia of India and the Indian Pharmacopeia are poles apart in terms of content. The raw materials in Ayush are sourced from regions with diverse geographical locations. Each of herb quality is varied as it is dependent on the climatic and water resources. In order to approve the final Ayurveda or herbal formulations, the raw materials are to be taken into consideration and this requires qualified-trained candidates who are either graduates or post graduates of Ayush and related fields.