Domestic ayurveda companies, eying a bigger pie of the Western markets, have embraced clinical trials in a bid to provide a scientific basis to their therapeutic claims.
The move is part of the effort by the likes of Dabur Pharma, Zandu, Himalaya, Ozone Ayurvedic and Charak Pharma to create a "scientific bank of knowledge" for ayurvedic medicines.
The export potential of ayurveda is pegged at Rs 11,500 crore (Rs 115 billion) and the domestic market size is Rs 2,000 crore. However, the reputation of these medicines had recently taken a beating as they were being panned internationally for alleged heavy metal content.
"Clinical trial is the first step towards standardisation, evaluation and credibility of a medicine," said S C Sehgal, managing director, Ozone Ayurvedics, which would have two products entering trials by mid-2006.
Zandu Pharmaceutical Works would soon have its liver drug, Heptalog (being co-developed with the Council of Scientific and Industrial Research), entering clinical trials. It has already tested Rumayog, Livotrit, Abhayasan and Trishun, involving over 200 volunteers.
Charak Pharma has lined up 8-10 products for clinical trials. Dabur Pharma, which has conducted such trials for chyawanprash, ashokarisht, dashmoolarishta and honitus, among others, has more products lined up in several indications.
"Newer formulations or combination of several combinations, too, are now being tested," said Apollo Spectra Research Foundation's clinical project manager, Jayanti Swaminathan.
New entrant Apollo Spectra Research Foundation, which has conducted herbal research for Himalaya and Wipro and dermal testing for Cholayil Pharmaceuticals (makers of Medimix soap), will be clinically testing drugs on vitilgo, wound care management and even weight loss.
Ayurvedic medicines were developed ages ago and documented in the languages of that era, leaving a disconnect with standardisation protocols. However, since the benefits are known, one just needs to work backwards and build the data.
"For product registrations abroad, one has to produce toxicity tests and scientific data to support claims," said Surinder Kher, chief executive officer, Jubilant Clinsys. Contract research organisations such as Clinsys are now being approached increasingly for such ayurveda trials.
The government, on its part, has started an initiative called Golden Triangle for pharmacology studies and clinical trials of Ayurvedic formulations.
The project, which would cover 14 disease conditions, involves the nodal agencies of Ayush, Council for Scientific and Industrial Research and Indian Council for Medical Research.
However, Ayurvedic formulations have no tight molecular structure, as unlike allopathic drugs, they have several active ingredients (18 herbs are mixed to obtain the Medimix soap).
"The formulation changes even if one ingredient is changed. One cannot establish bioequivalence in these polyherbal formulations," comments N S Bhatt, chief executive officer, Zandu Pharma.
Ayurveda is regulated by department of Ayush under the health ministry. Besides publishing the Ayurvedic Pharmacopoeia in 4 volumes, Ayush has 54 traditional recognised scriptures.
For a medicine emanating out of them, the manufacturer has to conduct only Phase III trials on humans.