Bad Medicine

Bad Medicine

Gresham revisited
Demand for herbal drugs has surged. Riding the crest of the wave are spurious and adulterated medicines

the market for herbal medicines and cosmetics is booming. Herbal products have flooded urban markets in India and are being exported. Advertisements of 'ayurvedic' preparations in newspapers and magazines and on television vie for attention. 'We can cure anything,' they claim, 'from acne to consumption and cancer.' But what ails the system that is consuming more and more resources? Has anything changed, or are these companies run by quacks in a new guise?

Consumers, tired of the limitations of allopathy and ready to believe in 'tried and tested' systems, are increasingly turning to herbal products. But clinical and field trials are not carried out on most of these products. There are no warnings on labels about the side-effects, no mention of the date of manufacture and of expiry, and sometimes no recommended dosages. Consequently, the 'tried-and-tested' becomes a trying and testing experience for the consumer.

On the other hand, manufacturers are having a field day. The market for herbal products, as against that for the raw material, is supply-led. Consumers are promised the moon by advertisements of products that were not meant to be 'curative' at all. The very philosophy of Ayurveda revolves around prevention. Moreover, in the absence of market regulation and standardisation of products, substandard preparations are being sold. In the past, vaidyas prepared and prescribed ayurvedic preparations themselves. Their efficacy was a question of self-esteem and reputation. For mass manufacturers, short-term gain from such a large market appears to be the only guiding principle.

Even more alarmingly for the nation, the increased demand for plants has placed a heavy strain on resources. Populations of some herbs are being rapidly annihilated. Poor conservation practices, in turn, are affecting supply. Adulteration of rare plant products has become common in the domestic market. As a result, genuine and quality herbal products are becoming scarcer. It's Gresham's law in its new avatar: the bad medicine drives out the good.

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Perjury and other afflictions

plants are used in both traditional and allopathic drugs. Around 600 million people in the country depend on Indian systems of medicine -- Ayurveda, Siddha and Unani. Export of crude herbs has also grown. A 1997 World Bank report says that revenue earned by India from export of crude herbal drugs in 1994-95 was us $53.2 million (approximately Rs 197 crore). While no precise figure is available, the size of the domestic market is nearly ten times the export market. According to one estimate, about Rs 900 crore worth of herbal medicines are produced annually in India. This excludes illegal trade and sales by unregistered firms.

While the average success rate for enterprises in other sectors is rarely above 10 per cent, this sector of the industry has faired better. Both small and big fish thrive. According to the office of the Drug Controller-General of India, there were 7,843 licensed pharmacies manufacturing drugs used in the Indian systems of medicine (ism). Currently, over 7,000 licensed manufacturers supply 55,000 pharmacies and 14,000 herbal dispensaries with plant-based products. There are also some unlicensed enterprises producing these medicines.

In this market, small companies may be doing as they will, but the big ones are raking in profit by the millions. These large manufacturers -- which almost constitute an oligopoly -- claim to have perfected the quality of their products, which sell well. Until a new brand arrives, that is. Even so, none of these products meets the standards laid down in the ancient texts. Unfortunately, only a handful of people know about the originally prescribed ingredients and there is no system to check up on standards. The law, too (the Drugs and Cosmetics Act, in this case), is silent on many points.

"One does not get the ideal combination of ayurvedic ingredients in commercial preparations. These 'herbal products' contain 90 per cent chemicals and only 10 per cent herbal material," contends Vaidya Balendu Prakash, director of the Vaidya Chandra Prakash Cancer Research Foundation, and chairperson of the Ayurveda, Siddha and Unani Drugs Technical Advisory Board (asudtab). He alleges that mass manufacturers resort to this tactic to make easy money.

Traditional practitioners agree that most medicines of herbal origin available in the market are spurious and adulterated, and violate the standards of the Drugs and Cosmetics Act (dca). "These preparations are quasi-ayurvedic and quasi-allopathic", says Hakim M A Lari, in-charge of the Unani section and head of the department of tashreeh (anatomy) at the Ayurvedic and Unani Tibbia College, New Delhi.

Preparations that are toxic are being openly sold in the market (see box: Lead in the medicine). Exaggerated claims about the effectiveness of herbal medicines through advertisements have become quite common. To check violation of standards, asudtab recently approved guidelines for punitive action against manufacturers and advertisers of these medicines under the Drugs and Remedies (objectionable advertisement) Act, 1954. There are 51 diseases for which advertisement of treatment is prohibited under Schedule J of the dca . These include aids , cancer, encephalitis, leukaemia, blindness, bronchial asthma, diabetes, change in sex of the foetus through drugs, disease and disorders of the uterus, baldness, obesity and paralysis. Violation of the prohibition is punishable by imprisonment or fines, or both.

Some drug manufacturers have represented to the department of Indian systems of medicine and health, as well as to the Drug Controller-General of India, asking for change in the rules governing use of certain chemicals mentioned in the section on patent and proprietary (p&p) medicine of the dca. State authorities have been issuing licences for manufacture of p&p medicine, but these often contain chemicals that are not included as ingredients of ayurvedic medicine in Schedule I of the dca.

"A number of herbal cosmetics available in the market are labelled 'ayurvedic drugs', even though they contain preservatives, additives and foaming agents, which should not be present. This way, manufacturers evade the higher excise duty applicable to chemical cosmetics," says Balendu Prakash. The duties payable for the p&p items and cosmetics are 8 per cent and 40 per cent, respectively. A case in point is Shahnaz Husain's upmarket 'herbal products' (see box: In the dock ) which had been doing well at home and abroad.

But even regularly sold downmarket products are below standard. "Take any brand of chyavanprash available in the market," says Ranjit Roy Chaudhary, chairperson of the scientific advisory committee on traditional medicine, Indian Council of Medical Research (icmr). "You will not find the date of expiry of the product." (see box: Chewing trash ) "There is no control over manufacture of these products in India. On the other hand, traders are exporting herbs used in these preparations, which are standardised in other countries," he adds.

It is not that ayurvedic products last forever. Like all organic things, they decay. Moreover, the potency of the organic chemicals in the herbs decreases over time. Unlike allopathic drugs, these preparations depend on low to moderate levels of chemicals. For this, it is necessary to determine even the season or month for collection of the herbs used, according to ancient ayurvedic texts. So the practitioners of the ancient system were fully aware of the limitations of time on potency and efficacy of a medicament.

The biggest loophole in the system is the absence of regulation and standardisation. Says Roy Chaudhary: "The absence of regulation has meant that traditional drugs can be manufactured without approval of any expert body."

A second and related problem is that no tests are carried out for toxicity of the drugs. Allopathic drugs are subjected to a battery of tests. Tests for harmful effects are carried out on at least two mammals, including their foetuses. If a drug passes these tests, it goes for a three-stage clinical trial and field trials. Some 15-20 volunteers, whose blood pressure, rate of perspiration and breathing is monitored, are administered the drug in the first phase. If it passes this test and no side-effects are noted, the drug is tested on 50-100 patients under close observation. In the third phase, it is given to 250-300 patients at three or four centres to test its efficacy. The drug is then ready for marketing. After this, however, a fourth and final test is conducted on over 2,000 patients -- a field trial.

But clinical and field trials are rarely undertaken for ayurvedic and unani medicines. Consequently, manufacturers can make claims which would be hard to substantiate. "Companies are simply collecting plants, making a preparation and marketing it -- without data to substantiate claims about their effectiveness or knowledge about its side-effects," points out Roy Chaudhary. "Sometimes ingredients are substituted, accidentally or by design, with dangerous consequences for the consumer.

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Building bridges

traditional systems of medicine may not be perfect. Their deficiencies - lack of quality control in preparations, poor standardisation, absence of controlled testing and clinical trials - are common knowledge. Yet, as more people turn to Ayurveda and herbal remedies, they are disappointed by the experience. Has that to do with the traditional system itself? Opinions differ. "Consumers have become more aware and expect allopathic benefits from ayurvedic medicines. Most of these contain chemicals and are far from the preparations prescribed in the ancient texts. Despite this, people are turning to Ayurveda because they are dissatisfied with artificial chemicals-based drugs and cosmetics," says Balendu Prakash.

At present, there are over one million practitioners of indigenous medicine in India. Ayurveda -- based on the Panchmahabhutas and derived from 5th century bc classics, the Charaka Samhita and Susruta Samhita -- appears to be a gold mine for the pharmaceuticals industry, encouraging the view that there is no need for basic research. "People are making money from Ayurveda but have an incomplete knowledge of the ancient texts," avers Balendu Prakash.

Ayurveda and allopathy have basic differences in theory and perception. Ayurveda treats the patient as whole. The history and genesis of any disease or malady, according to Ayurveda, is due to imbalance of three body humours (elements). Allopathy, on the other hand, does not believe in the ancient theory of 'humours'. There is often scant respect for such views among allopaths, who rely on detailed knowledge of physiology and anatomy for their diagnoses and prescriptions.

Traditional systems of medicine, however, sometimes have cures for diseases and disorders for which allopaths either have no cure or have remedies with many side-effects. Oral contraceptives for women, for example, are known to have many adverse effects in the long term. Contraceptives made from herbs, often used in rural and tribal areas in India, are a good alternative to the chemical ones available in the market. The icmr , with the help of the Central Council of Ayurvedic Medicine, is developing the first such contraceptive (see box: A viable alternative).

The traditional and the modern
While traditional practitioners and allopaths say that there can be no bridge between allopathy and Ayurveda and other Indian systems of medicine, the icmr brought the two together in a successful venture. About seven years ago, it decided to develop and test drugs with expertise from both fields. According to Roy Chaudhary, who is also chairperson of the scientific advisory group for clinical evaluation of herbal and ayurvedic medicine at the icmr , it was for the first time that such large-scale clinical and field trials have been conducted on traditional medicines. The aim was to enrich allopathy with indigenous knowledge, and to identify medicinal plants that are 'disease oriented'.

Certain common diseases like hepatitis, asthma, diabetes, development of kidney stones and filariasis were taken up. Groups consisting of experts on ayurvedic, unani and allopathic medicine, and pharmacologists, biochemists, chemists, statisticians, and epidemiologists were selected for each disease. The trials were conducted in modern hospitals and medical research institutions -- the All India Institute of Medical Sciences, New Delhi, and the Post-Graduate Institute of Medical Sciences at Chandigarh, for instance -- under the supervision of allopaths.

Full-scale analysis of the trials was done at four centres. The statistical analysis was done at the Institute of Statisticians in Chennai; pharmacological research at the Central Drug Research Institute, Lucknow, and the Regional Research Laboratory in Jammu. The medicines were manufactured in Varanasi.

The trials and testing were thorough and scientific, says Roy Chaudhary. To exclude any bias and eliminate the 'placebo effect' in the tests, control groups were maintained. Additionally, the names of participants -- both patients and doctors -- and drugs were kept secret during the trials. Though a number of these ayurvedic-allopathic combination drugs have been developed and tested, it will be some time before they become commercially available. The icmr , meanwhile, has successfully identified plants for treatment of hepatitis, diabetes, filariasis and bronchial asthma, and is developing a herbal contraceptive.

Doing away with barriers
People in developed countries are increasingly 'discovering' other systems, other medicines. Therapy and combinations of various systems of treatment have gained acceptance. Controversies are often thrown up by such 'alternative medicine'. Laws and regulation can help as well as hinder market development. One example is the controversy over the cholesterol-reducing drug Cholestine. Derived from the Chinese drug Hongqu , it is being sold at 30,000 stores in the us . Chinese drugs are banned in the us . But the California-based manufacturer of Cholestin, Pharmanex Inc., identified the ingredient in the herbal preparation from Hongqu , and produced it in its modern plant just like any other medicine. It then began a nationwide advertising campaign for the herbal medicine, which attracted the attention of the us Food and Drug Administration (fda). The fda charged Pharmanex with selling a drug in herbal disguise. Cholestin has not been banned yet, but the controversy still rages.

The case for ism is similar. If these systems can provide a better understanding of disease and medicine, allopaths should give it more importance. "The two systems should appreciate each other's viewpoint and enter into a productive relationship," says Anuradha Singh of nistads . "We need to identify areas of excellence in ism and integrate them with the mainstream."

To begin with, rules and regulations are required to ensure that the resource base -- traditions and raw material -- is not irreparably damaged. Such laws are still lacking in India. The business environment should not be biased against small-scale industry. But standards should be maintained so that public health is not compromised for the sake of profit. A better understanding of 'other' systems will enable both the traditional and the modern systems of medicine to benefit.

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Loss of the wild

the heavy demand on plant resources has led to rapid depletion of populations. Some medicinal plants are now endangered. A recent report of the ministry of environment and forests (Medicinal plants of India: Guidelines for national policy and conservation programmes) acknowledges that medicinal plants are under serious threat due to habitat degradation, loss and over-extraction. The gap between demand and supply is increasing progressively. In 1987, for instance, the ministry of health estimated that the demand for Picrorhiza kurrooa (or kutki , used to treat liver diseases) was 5,000 tonnes, while that for Gentiana kurrooa (gentian, used in treatment of digestive disorders and as a tonic) was around 100 tonnes.

According to the World Bank, 96 per cent of the herbs used in commercially available preparations are collected from the wild. A number of herbs and medicinal plants can be cultivated for commercial use, but there is little effort on the part of the industry in this direction. Of the 400-odd plant species used, less than 20 are being commercially cultivated.

Herbs are supplied by traders, who buy it mainly from people in tribal or rural areas at cheap prices. Along the distribution chain, the herbs and plant products become costlier. Adulteration is common. Sanjay Aggarwal of the Delhi-based company National Herbs laments that there is no quality control on herbs available in Indian markets. "You are not sure of what you are consuming."

At the same time, the people -- farmers and tribals -- have been alienated from the resource. The ban on collection of forest products by the department of forests in various states has not helped. Trade still thrives. Since it is difficult to establish that a herb has been collected from the wild, rare and endangered medicinal plants are being sold. Some manufacturers claim that they cultivate the herbs that they use in their preparations. Even if these claims could be substantiated, the majority of manufacturers still depend on the open market for raw material. Since the people who collect these herbs profit the least for their efforts, collection continues at a rapacious pace. Moreover, the collection process usually involves destructive harvesting or uprooting of whole plants. As a result, there is a serious threat to India's genetic wealth of medicinal plants (see box: Neglected resources ).

The International Union for Conservation of Nature and Natural Resources (iucn) has listed over 200 species of medicinal plants across the world that are rare or endangered. It estimates that the global loss of medicinal plants per annum is us $6 billion. The loss of medicinal plants in India has neither been evaluated in terms of the plants that are endangered, nor in monetary terms.

"There is an urgent need for regulation of trade in medicinal plants in India. We are losing precious herbs," says Roy Chaudhary.

Though a ban has been imposed on export of 54 plants and plant products, little has been done to implement it.

Ad hoc measures
Banning sale of herbal products or trade in medicinal plants, in fact, does little to protect the resource. The Supreme Court pointed out in a recent judgement (Pratap Pharma vs Union of India) that the government cannot impose an ad hoc ban on ayurvedic and other herbal medicines. Before banning a traditional medicine, the authorities should investigate the case and establish that chemicals not allowed under the category have been used in the product.

This task should be assigned to an expert body, set up under the provisions of the Drugs and Cosmetics Act -- in this case the Ayurveda, Siddha and Unani Drugs Technical Advisory Board (asudtab). The apex court also directed that asudtab examine and certify whether ayurvedic and unani medicines are meeting standards.

The ban on export of some herbs, which may be extended to other medicinal plants, has been dubbed ad hoc by the industry. According to industrialists, the export makes up for import of plant products to meet domestic demand. Says National Herbs' Aggarwal: "Bamboo camphor is mostly imported from Indonesia. But it costs Rs 2,500 per kg while the domestic product is available for Rs 20. But to meet demand and to ensure quality, manufacturers frequently have to buy the imported product."

Conflicting opinion
Scientist at the National Institute of Science, Technology and Development Studies (nistads) Anuradha Singh points out that there is no data bank on plants used in various Indian systems of medicine (ism). "There is no reliable information on how many people depend on these systems, the number of local practitioners, their areas of specialisation, diagnostic strengths and other such aspects," says Singh (see box: Endangered traditions ).

The need for good clinical studies and scientific research is another matter of great concern. Though people continue to buy herbal medicines, there is a growing concern about the side-effects of ayurvedic products. "Ayurveda will have to adapt to modern standards to sustain itself," says a trader. "Quality control, adequate research and development and manufacturing facilities are essential."

"Authentic ayurvedic medicines are far better than those available in the market. But these are hardly obtainable," says HakimLari. "But how can manufacturers be expected to deliver the goods when the government does not provide adequate facilities for research? Look at this college. It is poorly staffed. They treat us as second-class physicians," he laments.