Sunday, December 23, 2007

 

Changing definition for Ayurveda

Businessworld
Gauri Kamath

Can drugs that are derived from herbs described in India’s ancient ayurveda texts but using methods that might not be also defined as ‘ayurveda’? The answer to that question could be yes and no, depending on whom you ask.

The nub of the issue is a definition. According to the Drugs & Cosmetics Act of 1940, an ayurvedic drug is any medicine intended for external or internal use, manufactured exclusively in accordance with formulae described in the authortive ayurveda texts. The Act lists 54 such texts including the Charak Samhita dating back to the 3rd century BC.

A group of traditional ayurveda manufacturers alleges that this definition is under threat.

For some months now, the department of Ayush, under the ministry of health, which has oversight on Indian systems of medicine, has had plans to term ‘hydroalcoholic extracts’ of traditional herbs as ayurveda by including a group of them in the Ayurveda Pharmacopoeia. A pharmacopoeia is a compendium of known drug substances and their quality specifications. This, it believes, will help it standardise those extracts and their manufacture, thus raising the bar on quality, and hence, on safety.

But these extracts are not ayurveda at all, says Ranjit Puranik, CEO of ayurvedic drugs manufacturer Shree Dhoota Papeshwar, a member of the Mumbai-based Ayurvedic Drug Manufacturers’ Association. Ayurveda products involve the use of water as a solvent for the purpose of extraction. Herbs are boiled in water to a specific concentration before a decoction is obtained and then extracted to get the end-product. Using alcohol might provide some commercial advantages (you get more stable compounds, consume less energy) but this is not what the texts have prescribed, he says. And it might make the drug unsafe.


Others differ. Ghaziabad’s Association of Manufacturers of Ayurvedic Medicines (AMAM), which has FMCG company Dabur India as a prominent member, says the use of alcohol in extraction is prescribed in the texts. It points to Asav-Aristhas, a range of ayurvedic products made by fermentation — therefore, slightly alcoholic — as proof.

But there are two problems, says Puranik. One is that while alcoholic extraction uses 100 per cent proof alcohol as solvent, in the Asav-Arishta method of manufacture the alcohol content varies from 3 to 12 per cent proof. Two, unless the term ‘hydroalcoholic’ is well defined, companies might use a number of alcohols such as methanol, iso-propyl and ethyl. These could accumulate in the body. and over long term, cause toxicity and endanger the patient. Known side-effects of these compounds include blindness and pancreatitis. He fears this will also tarnish the image of ayurveda as a science.

Anita Das, secretary, department of Ayush, did not respond to telephone calls or answer an e-mail.

But Puranik has solutions. One is to prescribe a different regulatory pathway for products based on alcoholic extraction that requires more elaborate safety tests than ayurvedic products — whose safety has been established on the basis of ancient documents. These tests could be similar to what is required of chemical drugs. Some industry watchers agree there is enough ground for making the differentiation. “Just because you use the same plant does not make it ayurveda,” says Reenita Malhotra Hora, an ayurveda practioner in California who has authored two books on the science. “We are not against new medicine but let’s not call it ayurveda.”

Others, like drug maker Ranbaxy’s spokesperson, suggest a middle ground. “Water and alcohol extracts may be allowed as ayurvedic medicines as used traditionally. However, a separate regulatory pathway providing details of the studies, including safety, needs to be developed for the extracts using solvents other than water and alcohol,” he says। The government will be the final arbiter.

Also see:

Ayurveda

Ayurveda on mental health

Ayurvedic region in North Rajasthan



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