I agree with Kamal Bani-Hani, I think there are no scientific and regularity norms for safety quality of herbal products. s i can`t say any thing about the extent of these. But to extent i now is just taxonomical confirmation of a targeted plant and the knowledge of its photochemistry is still at infantry. We are still looking for the standardization of metabolites...

Not at all Sir. Proper identification of herbal plants is one of the biggest problem now days.

I think we'll all agree that the regulation of alternative remedies require a different paradigm to that of allopathic western medicine. First of all, reproducible physicochemical characterisation, fairly predictable pharmacological effects within fairly precise limits of dosing, and so on, are not easy with herbal remedies. Granted, anecdotal evidence suggests some efficacy but, as far as strength of evidence is concerned, we'll have to agree that it is not good enough to conclude efficacy. Therefore, the "omic" paradigm seems a good epistemological start of grappling with these remedies, while figuring out how to ensure that, given conditions 1 and 2, batch A will be the same as batch B for the same product, and will further elicit a known physiological effect, of known magnitude. I'm admittedly biased toward the allopathic paradigm of medicines regulation and the western model of disease. I'm not sure whether Abdalla's sees "omics" eventually bridging that chasm.

The clear answer to that is an emphatic NO. The fact that a product is herbal and does not mention adverse effects does not mean that it is free from them. What is more worrisome is the fact that many patients who are disillussioned or otherwise biased against the alopathic drugs that mention a huge list of adverse effects, resort to these herbal medications that have not undergone extensive , scientific valudation. Many a time, they can even adversely interact with the regular medication that the patient may be taking.

Some proponents of herbal medicine claim that if it does not help, at least it willnot harm. But that is not true. It should be useful as well as as have a good safety profile to justfy its marketing..

The regulatory authorities need to really tighten the noose in this regard since many of them are availble as over the counter drugs. I am not against herbal products perse, but to label them as totally safe and devoid of adverse effects or interactions is like living in a fool's paradise.

Batch to batch variability and many other factors that have not been controlled as yet in an effective manner prevent this. We hope that with more time, herbal products can be brought up to standard ..

Regulatory bodies concern with herbal drugs should be more stringent

My answer is NO as well. In the EU and in the Netherlands there are (some) regulations, but this is not sufficient. There are two aspects: proper regulations are needed, and these regulations should be enforced. This enforcement is in a lot of cases hardly or not effectuated. Moreover, lots of herbals are bought on internet worldwide. So, national or continental (e.g. EU) standards might not be sufficient. To get worldwide and effective standards another issue arise: political will and agreement. Here is the real issue: what is not acceptable in a certain culture or region, is fully acceptable in the home region of a certain herbal or TM. For example: rhino horn. This has no medicinal effect, is however extremely harmful for the animals, and there is a large demand in another continent (Asia) than the continent (Africa) where the horns are collected illegally.

Dear Leo, I also agree with your statement. Neither the regulatory norms are adequate nor their enforcement are satisfactory. The situation in developing countries is quite worrying.

In most of the countriest there is no regulation to ensure quality, safety and efficacy. Some countries the existing regulation is not sufficient. Considering the fact some international agencies like WHO and some countries are in the process of framing stringent regulation. It is also require to harmonoze regulation globally.

With regard to previous comments, in particular the remark by Leo van Raamsdonk, I wish to add the following: It is worth reading an old article by Morgan MR and Fenwick GR (The Lancet 336:1492-1495; dec 15, 1990). Giving several examples of natural foodborne toxicants, these authors point out „that if these compounds were to be presented as synthetic chemicals to the appropriate governmental committes, their use in food would not even be considered.“ In the section on public perception and risk/benefit, Morgan & Fenwick state: „public concern and scientific investigation should be based on the bioactivity rather than on the origin of the chemical.“ In my own (more drastic) wording I use the term „chemical racism“ when man-made and naturally occurring compounds are treated differently. With regard to safety issues, we should recognize all hazards, e.g. pyrolizidine alkaloids, mycotoxins and other chemicals of natural origin which can be present in herbal preparations.

There is a remarkable disconnect between risk as perceived by the general public, and actual risk as perceived by toxicologists and other safety professionals. For example the public tend to perceive GMOs as very hazardous, despite lack of evidence, but perceive herbal remedies as safe, despite the evidence that some contain very harmful substances (e.g. pyrrolizidine alkaloids) and that there are well-documented issues with incorrect plant identification, contamination with toxic metals, and deliberate adulteration with pharmaceuticals. I find the disconnect quite perplexing.

'Natural' remedies should be much more strongly regulated for the safety of the public, in my opinion.

The existing scientific standards and regulatory norms are based on the principles of professional competence, to deliver adequate and effective for ensuring the quality and safety. They ensure that the validation is conducted at all times by competent and qualified persons who act with total integrity and impartiality and who have been made aware of, and are mindful of, preferably through training, the ethical considerations to be borne in mind in respect of such research or experiment

ICMR ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS

Dear Prof. Tripathi

Thank you for your message. I am sure you are aware of several WHO publications and guidelines on the subject. For essential oils country and international quality standards are available. Similarly country regulations and laws are existent for medicinal and aromatic plants and their products. Availability of stringent regulations/laws alone is not sufficient. The real concern is the strict implementation of these regulations and timely and tough punishments for wrong doers.

At no point of time all herbal plants were considered as safe in any traditional system of medicine globally. Fish poisonous plants. animal poisonous plants and herbs harmful to humans have been identified and people have been cautioned about their misuse.

Enacting new laws and imposing more regulations will not wipe out the problems you raised, self-regulations and strict implementations are the need of the hour.

Best wishes and good luck.

There is a good Review about safety of herbal products in other countries. Please, at Attachment.

Thanks a lot Prof  Vladimir for sharing an informative paper.

Dear All,

It depends on national standards and the implementation of these standards. Thus, it is country dependent. There are some countries where baby food and fluor have been falsified. In similar countries I do want to buy medicinal plants.

My answer is definitely NO. They are not adequate and effective for ensuring the safety and quality of herbal products.

In our University, we have medicinal and herbal plants in Herbal Park. I doubt these plants are used for medicine purposes.

Maintaining the plants, their usage for the purpose, and maintaining safety and quality of the herbal products are very essential.

I also think so Dear Brenda;  neither  prevailing standards and regulatory norms nor their enforcement are  adequate and to satisfaction of consumers. Thanks for providing informative threads.

Dear Yogesh, At least in India there appears no adequate regulatory control over claims made several herbal drug products. To cite some examples for  joint-pains ,osetoporaris etc.,we read tall claims made by some pharma-co.. They advertise in news papers also sometimes with leading personality about efficacy of their drug.  There seems to be no legal control over such products. Same thing about herbal product for HT and diabetis.

The control or regulations as it is a major issue in pharma trade. The challenges remain the same. The existing mechanism is inadequate. There is an urgent need to create an institutional structure and framework. Else it is becoming a free for all situation. Which so a large extent is the case now.

We also have to look at the situation from governance issue. Who are the drivers to the industry. So to say who calls the shots. Is there a platform for herbal manufacturers to raise their voice. or consumers to raise theirs. Is there a level playing field provided before we talk of controlling the herbal trade.

I am more worried about consumers. I think through consumer protection organization there ispossibility to create separate section for such matter.Otherwise in name of herbal medicinal products -since it is supposed not to create any side effects ( is it aways so?) consumers will be duped by spurious products.

Though several regulatory measures imposed on Quality & Safety & Efficacy of Ayurvedic, Unani & Siddha system of medicines during last decade, there are enough scope to improve regulatory requirements to ensure quality, Safe & efficacious herbal medicines. Please refer attached file.