Pharma Voice

Stark realities of traditional medicines

Herbal drugs are increasingly being used worldwide since the last few decades, but the number of reports of people experiencing negative effects caused by the use of these drugs has increased to a larger extent

J Ramniwas

Although ayurvedic medicines have been used for thousands of years, basic research programmes need to be focused on the quality assurance. To overcome contamination from pesticide residues and heavy metals, there should be control measures to implement necessary standard operating procedures (SOP) at source. Good laboratory practices (GLP) and good manufacturing practices (GMP) are also needed to produce good quality medicinal products. Without all these measures, it is not possible to realise the dream of having a major share of herbal drug industry despite having gold mine of well documented and well-practiced knowledge of traditional herbal medicines.

Many ayurvedic companies are dedicated in spreading the magic of ayurvedic medicines all over the world. As we know, the traditional medicines have been used for centuries. We all have faith in their curing effects as our forefathers had adopted the same for their own treatments. But now the situation has changed. The stark realties are different. Herbal drugs are increasingly being used worldwide during the last few decades as evidenced by rapidly growing global and national markets of herbal drugs. According to WHO estimates, the present demand for medicinal plants is about $14 billion a year and by the year 2050, it would be about $5 trillion. Now people rely more on herbal drugs because of high prices and harmful side effects of synthetic drugs, and this trend is growing, not only in developing countries but also in developed countries.

Unfortunately, the number of reports of people experiencing negative effects caused by the use of herbal drugs has also been increasing. There may be various reasons for such problems. One of the major causes of adverse effects is directly linked to the poor quality of herbal medicines. Therefore, it has been recognised that insufficient attention was being paid to the quality assurance and control of herbal medicines. WHO has developed guidelines for the quality control of herbal drugs, which provide a detailed description of the techniques and measures required for the appropriate cultivation and collection of medicinal plants. Despite such guidelines, there is still a lacuna between this available knowledge and implementation, because farmers and other relevant people like producers, handlers and processors of herbal drugs are not much aware of WHO's guidelines and they continue their work as before without any quality control measures which results in inferior quality of herbal drugs with umpteen contaminants like heavy metals, pesticides and microbes. Therefore, the training for farmers and other relevant persons is an important measure to be taken to ensure good quality of raw herbal drugs.

Poisonous remedies

In the name of herbals or ayurvedic ingredients, people are using contaminated and banned drugs for quick remedies of their diseases. But investigations conducted by several organisations have revealed amazing results. The medicines used by people in the name of traditional medicines are contaminated with dangerous drugs. Instead of recovering quickly, there are chances of succumbing to health hazards. People have faith in the traditional medicine system and they use these medicinal products without any hesitation as they know there are no side effects. But when they come across this stark reality, it will be a big blow to their faith and they will have to say good bye to these medicines.

When money takes over…

Many are adopting unfair means to make money through this business. In stead of using ethical herbs, they are procuring illicitly traded extracts to make herbal or ayurvedic preparations. This is a pathetic state of affairs. The healthy philosophy and holistic approach of this business is losing its charm because of unfair trade practices being adopted by some people, not for the betterment of human society, but for their own selfish interests.

Today allopathic medicines are under the probe of different regulatory bodies and efforts are going on for their harmonisation. There is a strong data base for their quality, purity, and safety and efficacy parameters. Except from what have been published by the ayurvedic pharmacopoeia of India and WHO guidelines with regard to quality attributes of hurbs, this sector is almost unregulated unlike the traditional allopathic medical system. Yet we have to go a long way to establish the authenticity of the test parameters where impurity profile for the organic, inorganic and source of origin are yet to be established.

Safety (un)guaranteed

All the medicines before therapeutic usage have to pass through phase-I, phase-II and phase-III of clinical trials by taking the different geographic locations, age, sex, body mass and number of patients covered under the clinical trials. If the medicine is found safe without any adverse reactions, it qualifies the test of therapeutic usage. In case of traditional medicines, no scientific studies have been carried out to determine their efficacy and adverse drug reactions. This needs to be addressed in the days to come to increase usage of these medicines with proper scientific outlook.

The patients across the world prefer medicines that do not have any side effects. In this hope, they go for traditional medicines because of their trust and faith that their forefathers were getting while using these medicines. But they do not know that environment, which is the source of origin of these medicinal plants, is highly polluted and the soil contains hazardous chemicals like pesticides, insecticides and herbicides. Also, the ground water where these herbs are grown is contaminated with various kinds of hazardous pollutants and trace elements that are absorbed by these plants. If the same herbs are used for medicinal purpose, chances are that they will put the patients' health at a potential risk.

All the regulatory bodies in the world over must recognise and reach for harmonisation in establishing the guidelines and regulations so that in the days to come, people may feel more comfortable to protect themselves and enjoy their life with full potential.

Several cases of adverse effects of herbal drugs have been reported in developed countries during the last few years, which are allegedly caused by taking herbal products or traditional medicines prescribed by the practitioners of indigenous systems of medicine. These products may be contaminated with excessive banned pesticides, microbial contaminants, heavy metals and chemical toxins which cause various deformities like congenital paralysis, sensory-neural defects, liver and kidney damage etc. These contaminants may be related to the source of herbal drugs, if these are grown under a contaminated environment. Chemical toxins may come from unfavourable post harvest techniques and wrong storage conditions or chemical treatment during the storage period. Some of these environmental factors may be controlled by implementing good source; good agricultural practices and standard operating procedures (SOP) for producing good quality herbal products.

(The author is Director-Quality Management and Regulatory Affairs, PharmaOcean. He can be contacted at jramniwas@pharmaocean.com)