New Delhi, Jan. 9: Swami Ramdev’s pharmacy in Hardwar is among hundreds across India producing cocktails of herbs and minerals that have never undergone the rigorous safety and efficacy testing mandatory for modern drugs.
While research on traditional medicine ' ayurveda, siddha and unani ' has intensified in recent times, medical experts warn that Indian drug laws allow traditional medicine products to slip into the market without adequate testing and with little data on how they interact with other medicines.
Existing laws allow the sale of traditional medicines without the scientific studies mandatory for modern drugs, provided the formulations are listed in one of 86 ancient texts of ayurveda and siddha.
“Ayurvedic drugs can use any of 2,500 products of plant origin, 150 products of mineral origin and 75 products of animal origin,” said Shiv Kumar Mishra, adviser to the Central Council for Research in Ayurveda and Siddha.
The formulations listed in the classical texts are considered safe because they have been used for centuries.
However, traditional medicine companies have introduced a number of proprietary formulations that might include new combinations of herbal compounds said to reduce high cholesterol, prevent infections, boost immunity and lower blood sugar, among other claims.
Medical experts say it is unclear how many of such proprietary combinations have been put through the rigorous studies required for modern drugs. “A correct interpretation of drug laws makes it mandatory for any new combination of herbal formulations to be treated just as a modern drug,” said Chandra Gulhati, editor of MIMS India, a drugs journal. Any new combination of even classical formulations would thus have to undergo studies to establish safety and animal and human studies.
They say safety concerns over combinations of herbal formulations stem from the possibility that herbal compounds might interact among themselves or with any modern drugs that patients might be taking simultaneously.
More than 110 modern drugs are based on plant extracts and possible interactions between them is always a concern when patients take more than one drug.
Pharmacology experts say traditional herbal products might be mistakenly assumed to be immune from interactions.
For instance, Gulhati said, concentrated extracts of garlic might interact with aspirin and raise the risk of bleeding in the stomach. A herbal compound claiming to boost memory might interact with the thyroid hormone, while extracts of fenugreek (methi) or karela (bitter gourd) taken with modern anti-diabetic drugs might lower blood sugar levels to precarious levels, he said. A traditional compound derived from sea conches might interact with an anti-epilepsy drug.
Traditional medicine experts argue that it would be difficult to apply the same rigorous standards that go into approving modern drugs on new herbal cocktails.
“Herbal formulations are mixtures of several compounds and we don’t always know the active ingredients in them and how exactly they act in the human body,” said Kulwant Singh, director of the Jammu Institute of Ayurveda Research. Deciphering the detailed pharmacology of herbal products, Singh said, is a long-term research goal that will require significant infusion of “funds and scientific staff”.
Herbal drug companies as well as academic researchers in India have indeed been conducting clinical studies to prove the safety and efficacy of some herbal products. “Many new combinations have been in the market for years. We’ve had no reports of problems from consumers,” said Jayaprakash Narayan, former head of the scientific advisory committee of the ayurveda research council.
However, pharmacology experts point out that India does not have an efficient system for tracking adverse reactions from any drugs ' whether modern or traditional.