Govt test for ayurveda drugs

Pre-clinical studies under the aegis of CSIR.

Days after a public controversy broke out over the contents of a popular ayurvedic medicine, the government has decided to infuse a dose of transparency into the traditional system of medicines.

The move begins with clinical trials and pharmacology studies of ayurvedic formulations.

Under a programme termed Golden Triangle, the medicines will have to pass through the department of AYUSH (ayurveda, yoga and naturopathy, unani, siddhi and homoeopathy), the Council for Scientific and Industrial Research (CSIR) and the Indian Council for Medical Research (ICMR)before going to the Drug Controller-General of India for approval.

At present, ayurveda, yoga and naturopathy, and unani and siddhi medicines, only need a clearance from AYUSH, which can be obtained by citing traditional scriptures from which formulations are ostensibly derived.

Allopathic medicines, on the other hand, go through extensive clinical testing and trials before they are approved by the DCGI.

Extensive investigation may also help traditional medicines pass muster in developed markets like the US, the UK, Canada and Australia, which now frown upon traditional Indian medicines.

"Ayurveda will have to be more transparent if it has to go global. Benchmarks for quality have to be established and adhered to," said an analyst.

The Golden Triangle project, which is expected to be completed in five years, entails detailed documentation of formulations by AYUSH. This will be followed by pre-clinical studies, under the aegis of CSIR.

In the third and the final stage, formulations will go to ICMR, the research wing of the ministry of health and family welfare, which will conduct phase I, II and III clinical trials in various hospitals in the country.

AYUSH has been entrusted with the task of identifying formulations in 14 disease conditions. It has already begun work, on a priority basis, on five conditions: benign prostrate, sleep disorders, cardio-vascular, neurological and joint disorders.

"There is a need to usher in greater transparency and acceptance of the safety profiles of traditional medicine. We have begun with ayurvedic medicines... but we have also had meetings with unani and siddhi councils," said Vasantha Muthuswamy, senior deputy director-general of ICMR.

Traditional medicines, documented in scriptures, escape scientific investigation and get easily embroiled in controversies. With this initiative, at least ayurvedic medicines will be considered at par with any modern medicine.

While the CSIR, the nodal agency for scientific research, will look at animal pharmacology, toxicity data and pharmacokinetic data, the ICMR will document the therapeutic effect of ayurveda medicines on humans through clinical trials.

"Once the medicines reach us, we will conduct clinical trials in modern as well as ayurvedic hospitals across the country to check for their efficacy and safety," Muthuswamy added.

However, developing medicinal chemistry for ayurvedic formulations will be no easy task as it does not have tight molecular structures like modern drugs.

Modifying even a small quantity of a single ingredient can make it a new formulation with dramatically different therapeutic effect. This makes it that much harder to homogenise traditional medicines. Magic pill

The 3 stages of Golden Triangle

Detailed documentation of formulations by the department of ayurveda, yoga & naturopathy, unani, siddhi and homoeopathy

Pre-clinical studies, under the aegis of Council for Scientific and Industrial Research

Conduct of Phase I, II and III clinical trials by the Indian Council for Medical Research