Hypothetical cure

in india, herbal medicines worth Rs 900 crore are produced annually while the revenue earned through their yearly export has risen to Rs 120 crore. Despite this there is no check to ensure that only genuine medicines make it to the shelves. Even the drug controller of India, P Sengupta, says his office acts only on specific complaints.

"We urgently need to have a regulatory body if we are to utilise our traditional knowledge of Ayurveda in an effective manner, without losing credibility," says Ranjit Roy Chaudhury, chairman, scientific advisory committee on traditional medicine, Indian Council of Medical Research ( icmr ).

Owing to the absence of any regulation -- for instance, an expert body declaring the traditional drugs and injectables to be below prescribed standards under the Drugs and Narcotics Act, 1940 -- companies are simply collecting the plants, making a preparation and marketing it.

The Indian System, of Medicine ( ism ) includes Ayurveda, omoeopathy, Unani, and Siddha. While traditional medicine hospitals account for 1,690 hospitals in India, there are at least 13,770 dispensaries of traditional medicine.

According to the office of the Drug Controller of India, there were 7,843 licensed pharmacies manufacturing drugs used in the ism and 857 licensed pharmacies manufacturing homoeopathic medicines, in 1991. In addition, a number of small scale and unlicensed enterprises operated in the small scale sector.

The working group on Indian Systems of Medicine and Homoeopathy ( ism and h ) brings together policymakers from various ministries and departments dealing with traditional medicine and medicinal plants. For the Ninth Five Year Plan, the group sought an outlay of Rs 1,840 crore. A considerable proportion of this has been recommended for developing some standards and ensuring that quality is maintained.

Over 7,000 plants are known to be used for medicinal purposes. In addition to domestic consumption, India is a major exporter. Three-fourths of the plant-based drugs are found in the natural state in India. Over 7,000 licensed manufacturers supply 55,000 pharmacies and 14,000 herbal dispensaries with plant based products. The herbal medicine industry generates over 200 million days of employment annually, according to rough estimates.

The industry gets its raw material from traders, who subcontract collectors in the rural areas to provide them the plant material. Due to this method of obtaining raw materials, it is easy to adulterate the products.

Plants, a major source of therapeutic medicine, are used in allopathic as well as traditional medicines. However, in the absence of quality control measures one is not sure whether one is indeed consuming the unadulterated herbal preparation as mentioned on the container, or the relief is due just to a placebo effect.

While making an herbal preparation, the development of the plant is important. This is because the quality of the active ingredients responsible for the therapeutic activity is affected by different environmental parameters, the time of harvest, and duration of storage.

"The importance of these factors has been laid down in ayurvedic literature and cannot be ignored," says A K S Rawat, scientist at the National Botanical Research Institute ( nbri ), Lucknow. "For instance, the liver protective action of the active chemical from the punarava plant root ( Boerhaavia diffusa ) is highest among the plants collected in May, when the plant is under acute stress. The amount of picroliv, the active chemical of another liver protective drug used for the treatment of hepatitis b from the plant Picrorhiza kurrooa decreases with storage. The amount of alkaloids, the active chemicals from the plant Coscinium fenestratum used in fevers and as a tonic, varies with the location where it is grown," he adds.

A number of plant parts such as stems, roots and leaves that resemble the medicinal plant parts are being sold as genuine herbs. Companies buy the substitutes since their cost is low. "When we went to the market to purchase Saracca asoca, the real source of Asoka that goes into the preparation of Asokarishta, used for treating menstrual disorders, we were offered a choice between a substitute at the cost of Rs 20 per kilogram and the genuine herb costing Rs 200 per kilogram. You can well imagine what a small company with no checks on quality or specifications will choose," says S Mehrotra, nbri scientist, who has been working on standardisation of herbal medicine preparations.

The nbri has developed protocols whereby at least some of the ingredients of herbal drugs can be identified even in the powdered form. For instance, the leaves of Taccus baccata subspecies wallichiana , a plant found in the Himalaya are very similar to the Abies spectabilis . The chemical constituents are, however, totally different. While the former contains taxol, a drug used in the treatment of cancers, the latter contains an alkaloid used in the treatment of cough and cold, loss of appetite (anorexia), constipation, and nausea.

The leaves of Taccus baccata are used in the preparation of Talishpatra, a drug used in many Ayurvedic preparations. "If the leaves are supplied in powder form it is impossible to distinguish between the two," says Mehrotra. "We have developed a simple technique for distinguishing between the two, but who can force the manufacturing companies to maintain standards?" she questions. "Commercial preparations of the drug Talishpatra from Delhi, DehraDun, and Lucknow were identified to be containing Taccus baccata, while those procured from Amritsar and Calcutta contained Abies spectabilis. "

Often the plant material is contaminated by bacteria or fungus. Amla, for instance, being a fleshy fruit is easily contaminated by fungus while drying.

"In absence of any quality control for selling these preparations, we could well be eating contaminated products," says Mehrotra.

Agreeing with this, Chaudhury says "The area of regulation of ayurvedic drugs is like no man's land with no regulation on the companies or the products. In absence of any law, virtually anything is being sold in the name of ayurvedic medicine." The scientists at the nbri did make an effort to know the quality control measures being adopted by the companies. Questionnaires were sent to 80 companies engaged in the manufacture of herbal medicines. However, only four of them responded.

Presence of toxic material in herbal medicine, variation of the constituents from batch to batch and the alleged mixing of allopathic medicines have raised serious concern about the safety of the consumers .

While most of the studies have been based on Chinese herbal medicines, few reports on the quality of Indian herbal medicines exist.

"In our study of 21 herbal medicines commonly used in the ayurvedic and unani systems of traditional medicine for the treatment of hypertension, rheumatoid arthritis, renal stones, and male infertility, high levels of arsenic and lead were found," says S B Lall, additional professor at the Department of Pharmacology, All India Institute of Medical Sciences, New Delhi.

Often, no clinical trials are undertaken before an ayurvedic drug is launched. They do not undergo the testing that allopathic drugs have to undergo. An allopathic drug is first tested for harmful effects in at least two animal species. The effect on the foetus of animal species is also tested. If the two tests are negative and no toxicity is established, the drug then goes through various phases of human clinical trials

Firstly, the drug is administered to about 15-20 patients and the blood pressure, perspiration, and breathing monitored. If the drug shows no side effects in the first stage, the efficacy of the drug is tested on 50-100 patients under close observation. If the efficacy is established, the drug then enters into the third phase trials where it is administered to about 250-300 patients in three or four different centres. The efficacy is then monitored. The drug is then ready to be released. A post market surveillance is conducted on the first 2,000-3,000 patients who have been administered the drug to check for any side effects. If all is well, the drug is ready to be launched.

In the preparation of ayurvedic drugs, companies and farmers resort to cultivation rather than collection from the wild. This means that pesticides are used. "These residues could then find their way in preparations where the plant is used in the crude form," says Mehrotra. "Brahmi, the basic ingredient of the drug Memory Plus, is known to absorb heavy metals like cadmium. What effect this could have on the body has not been looked into."

"No toxicity testing, efficacy testing, or clinical trials are required for the launching of an ayurvedic drug. The ayurvedic medicine industry is really a short cut to making money," regrets Chaudhury.

"We need to set up a separate directorate of Ayurvedic medicine which would ensure standardisation, quality control, and authenticate the claims of the drugs. This would play a regulatory role too. Only then will effective and genuine ayurvedic medicines be available to the people," feels Chaudhury.