Need of the hour : clinical trials on AYUSH Drugs

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Although physicians of modern and ancient medical systems have not reached a scientific conclusion in integrating appropriate therapies of their systems due to lack of scientific evidence, integration has already taken place at the patient level by consuming drugs of multiple systems by the patients themselves, observed scientists of both the systems while attending a workshop at Manipal University in Karnataka state.

The only thing now needed is clinical research on medicines of all Ayush streams and a Pharmacovigilance report to develop integration. This area should be given preference in the ‘Make in India’ schemes of the Central government, they opined.

Contemplating on the hurdles for the Ayush drugs and therapies to become ubiquitous in countries outside India, the two days workshop has found that the major barrier for the universal growth of India’s ancient treatment systems is the impossibility of conducting clinical trials on traditional medicines outside India. Since no Ayush drug has been approved by the US FDA, no clinical trial on any of the Ayurveda or Siddha medicines is possible in a foreign country. It is possible only in India. So, integration of Ayush and Allopathy drugs and therapies can be done in India only.

The researchers and physicians attended the workshop are of the opinion that integration can be possible if the government shows special interest by providing ample support. For proof of efficacy, the clinical research data should be taken as evidence in medical field, animal experiments data should be supplementary.

“World is seeking clinical evidence for Ayush drugs from India. Government should take special interest in conducting clinical researches on Ayush drugs. For this, the government has to allocate special funds and initiate special projects for the programme”, said Dr. Arul Amuthan, team leader at the department of integrative medicine at Manipal University.

Commenting on the subject, physicians and scientists from both the sides have said that immediate step needed for it is to draft the ethical guidelines to conduct clinical research in integrative medicine. Without guidelines, no research can be conducted. Government should form a panel of experts from various medical fields to frame the guidelines for clinical research and for the regulation of integrative medicines and therapies. Allopathy physicians having additional qualification in Ayush systems or Ayush practitioners with qualifications in modern system/pharmacology should be included in the team.

In the beginning, government should take steps for creating a foundation for research in the area of integrative medicine and thereby. Measures should be made for collecting data, safety reports helping patient autonomy, training for practitioners of both modern and ancient systems and a set of guidelines for treatments at international level. Finally it requires insurance for integrative medical care.

The workshop on integrative medicine was attended by scientists and researchers from universities in India and from Sri Lanka. Prof. Dr. R.S. Ramaswamy, Director General, CCRS New Delhi, Dr. Rajendra Kumar, Siddha Regional Research Institute, Puducherry, Dr. Sathish Pai and Dr. Sudhir Nayak from  Department of Dermatology, Kasturba Medical College, Karnataka, Dr. Krishna Sharan, Department of Oncology, Kasturba Medical College, Dr. Shyamala, Department of Obstetrics & Gynaecology, Kasturba Medical College and Dr. Vasudha Devi, Dept. of Pharmacology, Melaka Manipal Medical College were among the prominent speakers.

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