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Policy Matters

AMMOI to protest against proposed GCP guidelines for ASU drugs

Chennai (PB): The Ayurvedic Medicine Manufacturers Organisation of India (AMMOI) will soon approach the Department of AYUSH seeking modifications in the draft guidelines that the department is planning to introduce with regard to Good Clinical Practices for ASU drugs, under Schedule T of the Drugs and Cosmetics Act, 1940.

According to ayurvedic medicine manufacturers of Kerala, the guidelines are against the basic principles of the age old Ayurveda system practised in the country, and need to be revised. Before implementing it in its present form, the government should reconsider the proposed guidelines in the interest of the age old system and the traditional medicine manufacturers. If they are introduced without amendment, it will help only some multinational companies to enter into the sector and monopolize India’s traditional healing method. Besides, it will bar the treatment meted out to the foreign patients here.

While releasing a statement in Thrissur in Kerala, the secretary of AMMOI, Dr D Ramanathan said the ayurvedic medicines are purely classical medicines and are manufactured after complying with the provisions of the Drugs & Cosmetics Act of 1945, hence there is no need for further regulations like clinical trials. He said for the last 65 years, the ayurvedic industry in India is following the provisions of the Act and so far no case of side effects was reported elsewhere in the country. He said the draft guidelines are not different from those for the modern medicines.

He further said if they are introduced to encourage research and development activities in the ASU sector, it should be introduced after considering the opinions of the stakeholders of the industry. He said AMMOI will submit a memorandum signed by all the manufacturers and practitioners of ayurvedic drugs from Kerala to the union health minister and to the Ayush department in next week.

According to him, the guidelines become hurdles to the traditional practitioners of India to treat their patients according to their physical conditions. If the practitioners are forced to follow the guidelines, they will be dragged into the court in the end, he alleged. The Indian scientists and regulators should design GCP guidelines after considering the knowledge related differences between Ayurveda and western biomedicines. He pointed out that the ayurvedic system of medicine has survived and thrived over a long period of time, which is an indication that it works. So to foster good clinical research, it is greatly desired that the principles driving these guidelines should be ethical, transparent and scientifically unbiased, Dr Ramanathan argued.

The department of Ayush is planning to introduce the guidelines to develop methodologies for research and evaluation, to improve the quality and value of research, to provide appropriate evaluation methods to facilitate the development of regulation and registration in ASU medicines and other traditional medicines in a phased manner.

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