RECENTLY in Delhi, a top banker’s wife was admitted to hospital after doctors detected a liver malfunction. On examining the patient’s blood samples, pathologists found very high levels of heavy metals — arsenic, lead and mercury. This baffled the doctors, till they were told the lady, in her 50s, had been taking ayurvedic medicines for the past five years to try and fix a constipation problem.
The case may be alarming but is not unusual, insist seasoned medical practitioners. A similar incident was reported in a Boston hospital some years ago, when a patient complained of intractable seizures. Tests showed his blood’s lead level to be 89 units. Normal levels for an adult are under two units.
It was later found that the Indian-born patient, also in his 50s, was taking an ayurvedic medicine for arthritis. The medicine was found to have high metal levels, and he’d been on the dose for six years.
The incident lead to a survey by Harvard Medical School, the results of which were published in the December 2004 issue of the Journal of American Medical Association. The study associated lead, mercury and arsenic intoxication with ayurvedic medicinal products.
Figure it out The herbal drugs industry in India is estimated at Rs 2,300 crore, with a 15 per cent annual growth rate. It covers 5,000 companies. The global ayurvedic products market is reportedly worth $14.2 billion. It found one in every five such products had more than acceptable levels of heavy metal. This, said the survey, put users at risk of metal toxicity.ARE unsafe medical products being labelled ‘‘ayurvedic’’ as a marketing gimmick and giving India’s ancient system of healing a bad name? Certainly, the Union Health Ministry is taking it seriously enough to order an inquiry. ‘‘We are waiting for the report before any decision is taken,’’ says Anbumani Ramadoss, India’s health minister.
According to the Harvard researchers, although the health hazards posed by these products vary — depending on the degree of metallic content and the characteristics of the person taking it — a direct link with ayurveda cannot be ruled out. In interviews, Robert B. Saper, chief investigator of the Harvard study, has spoken of over 50 published accounts since 1978 of heavy metal poisoning in infants, children and adults where use of ayurvedic products was a possible cause. The list includes a study of 12 patients treated for lead toxicity, under the aegis of the Centers for Disease Control and Prevention (CDC), Atlanta.
While cautious in rushing to judgement, some doctors in India voice similar concerns. ‘‘We come across cases of metal toxicity where the underlying cause is longtime use of ayurvedic medicines,’’ says Dr Ajay Kumar, senior consultant and liver specialist at Delhi’s Indraprastha Apollo Hospital.
According to doctors, the toxicity is most damaging to the digestive tract and the liver, and has adverse effects on the nervous system. While arsenic and mercury can cause liver failure, lead tends to affect the nerves, brain and intestines.
‘‘The problem with the metals is that even if we take them in very small doses, they can accumulate in the body,’’ says Dr Anil Arora, senior consultant gastroenterologist at Delhi’s Ganga Ram Hospital.
In 1996, the Supreme Court had ruled no doctor practising modern medicine could prescribe ayurvedic drugs, as he or she was perceived to lack knowledge of the subject. Even so, many ayurvedic medicines are available over the counter, and require no prescription.
‘‘As the medicines don’t require a prescription for purchase, nobody knows how long to take them and when to stop,’’ says Dr Kumar, ‘‘people use the medicine for a long time without knowing what the proper dosage is.’’
Even Dr Ashwani Kumar, who holds the office of drug controller general of India, agrees: ‘‘You require no sales licence, so anybody can sell the drugs.’’
‘‘In ayurvedic medicines, once the formulation is made you can’t check the ingredients. So you can assess quality but not quantity.’’ Ashwani Kumar drug controller general ‘‘People who are making an issue of the heavy metal presence don’t know ayurveda. Heavy metals are integral to some formulations and have been used for centuries. There is no point of doing trials as they have been used safely and have mention in our ancient texts. A separate part of the Drug and Cosmetic Act, 1956, deals with ayurvedic formulations. We have pharmacopia, like allopathic medicine, and manufacturers have to follow that. We ensure quality.’’ Tara Dutt Joint secretary, Department of AYUSH ‘‘The Department of Indian Systems of Medicine (AYUSH) had offered to certify manufacturers for the safety of the drugs. But there are no takers. There should definitely be some checks and regulation.’’ Ranjit Roy Chaudhary chairman, Delhi Society of Promotion of Rational Use of Drugs ‘‘No quality and lack of regulation is ... discrediting ayurveda. I believe they use heavy metals, we have always suspected it. We have had cases of toxicity — of kidney and liver damage due to mercury deposition, nerves and abdominal problems due to lead.’’ Anoop Misra professor of medicine, Delhi ‘‘The heavy metal toxication is an important issue. It will be taken up at the drug consultative meeting in June ... to be attended by all state drug controllers. We will discuss listing of ingredients, labelling, claims made by companies and licensing issues’’ Anbumani Ramadoss Union health minister
The problem may be regulatory. As per Dr C.M. Gulati, former World Health Organisation consultant and editor of the Monthly Index of Medical Sciences, the laws governing ayurveda are extremely amorphous.
For one, there’s no scientific proof of efficacy. While allopathic drugs have to establish their efficacy and safety through trials, this is not required for ayurvedic drugs. The remedies have only to be listed in a ‘‘classical ayurvedic text’’.
There are 57 such formulations. Newer formulations come under the category of ‘‘Patent and Proprietary Drugs’’ and can be made only by licensed manufacturers. ‘‘But no trials are required for new drugs,’’ says Dr Gulati, ‘‘any mention of the plant, in any text, for a particular disease is considered to be safe.’’
Ayurvedic preparations are never tested before coming to shop shelves, neither do they require any certification to get there, points out Dr Gulati. Anybody can manufacture ayurvedic preparations provided he has a licence from a state-level drug controller. The manufacturer can sell his ayurvedic preparation throughout India.
Another problem relates to lack of standardisation and quality control. Each manufacturer obtains his raw material and plant inputs from varied sources. ‘‘We know what 500 mg of allopathic medicine contains,’’ says a doctor, ‘‘but different plants grown in different areas vary in their constitution of various elements.’’
Many manufacturers don’t bother with separation of the active ingredient in the plant. As such, the whole plant or plant part may be used in the making of the ayurvedic tablet.
Finally, there are no strict regulations for labelling and packaging, requirements of inserts and explaining side-effects, if any. ‘‘Nobody knows what is present in the drugs,’’ says Dr Gulati, ‘‘even if this is listed, the language isn’t comprehensive.’’
THE war between practitioners of allopathy and ayurveda is not new. Both systems of medicine have their believers and that’s fair enough. Indeed, India is justifiably proud of it’s traditional knowledge and heritage in the science of cure, of which ayurveda is a key parameter.
Yet what some fear is that quack theories of ayurveda are being deployed to produce medicines that bear fancy brand names but may just be a health hazard. The reputation of India’s ancient wisdom probably needs to be protected by tighter rules. Ayurveda needs governance.
The AIIMS alarm
A few years ago, in a study conducted in the Department of Pharmacology at Delhi’s All-India institute of Medical Sciences (AIIMS), Dr S.K. Gupta, then head of department and principal investigator, found misuse of corticosteroids in some drugs dispensed as preparations from alternative systems of medicine. The screening for corticosteroids was carried out on 120 samples of alternative medicines — mainly dispensed to patients suffering from asthma and arthritis. It found 38.32 per cent of samples adulterated with steroids. Most samples were submitted for testing by either a medical practitioner or patients themselves. They suspected effects of steroids after use of these drugs. The AIIMS researchers pointed out lack of proper quality control mechanisms that could verify ingredients or efficacy of ‘‘alternative medicines’’ had led to a proliferation of spurious drugs. These contained corticosteroids but passed themselves off as ayurveda or unani. Small matter of heavy metals Lead: Lead toxicity reveals itself in gastrointestinal (GI) complaints, neurological dysfunction, and anaemia. Children are more prone to Central Nervous System (CNS) dysfunction, including seizures. Arsenic: Arsenic toxicity symptoms vary with concentration, rate of absorption, and the chemical form ingested. GI complaints (even diarrhoea) are observed in some cases. Neurological complaints have been noted, as has kidney failure. Mercury: Mercury toxicity often presents itself as a CNS dysfunction, for instance, erethism. Chronic exposure may lead to tremors. Inorganic forms of mercury may cause severe GI complaints. Mercury affects the liver. Acrodynia (‘‘Pink Disease’’) is observed in children