While it is true that standardization attempts arose out of the need to deliver a quality-assured product, the situation has become all the more complex with the introduction of the so-called standardized herbal drugs.

• It is seen that ‘standardized’ herbals may not have the intended traditional functions attributed to the original formulae since they have now been strengthened with respect to a particular constituent for purposes of quality control.
• While a standardized extract can ensure that sufficient amounts of the herb’s constituents (marker compounds?) are present to deliver an efficacious product, standardization presents herbs as medicines in a way that is fundamentally different from the way they were traditionally meant to be given.
• Standardization renders herbal drugs into ‘phytopharmaceuticals’, which are more drug-like forms rather than herbs used in the traditional sense. Once a herb is regarded as a phytopharmaceutical, it is a short stretch for it to be considered as just another drug.
• Many herbs sold as standardized extracts are not consistently standardized to one marker, because it is not clear which of the constituents are responsible for their therapeutic action. Nettle root is standardized by one company to 5% amino acids, by another to 8% sterols, and a third uses 35 ppm scopoline. Likewise Echinacea can be standardized to at least three different constituents (echinosides, polysaccharides and polybutylides) and each is used as a marker by different companies.
• According to Joerg Gruenwald one of the editors for the German Commission E Monographs—one of the standard books on medicinal herbs and plant products in the western world, only 5% of botanicals are standardized to the one and only known active constituent. A maximum of 10–15 botanicals have undergone well-controlled clinical trials and it is doubtful whether all of them will hold up to Food and Drug Administration (FDA) standards.
• Standardization cannot be equated with efficiency and potency. While they may offer no advantage in terms of efficacy over the use of more traditional high-quality herbal products, developing a truly standardized extract would require such tremendous technology that not only will smaller companies that can manufacture quality products due to lesser quantity requirements be pushed out of the picture, but the technology applied to botanicals also will increase prices dramatically.
• This means that using a quality non-analysed herb product might be just as well or even better than a standardized extract based on known active ingredients. Also it will be cheaper in cost and even the quality of herb used is likely to be superior because the manufacturer would be selecting herbs based more on quality than quantity.
• According to Dr. Rudolf Bauer, one of the leading botanical research scientists in Germany, the three primary reasons for the standardization of herbs into phytopharmaceutical drugs are as follows:
  1. To be regarded as rational drugs, they need to be standardized and pharmaceutical quality must be approved.
  2. For pharmacological, toxicological and clinical studies, the composition of the herbal drugs needs to be well documented to produce reproducible results.
  3. WHO has published guidelines to ensure reliability and repeatability of research on herbal medicines.
• Herbs, unlike chemical drugs, themselves are not patentable. However, a standardized product used for research is patentable for the process of extraction and standardization.
• The high cost of standardization and patentability instigates more commercial interest rather than a desire to heal or to understand herbal medicine. As a result it seems like the pharmaceutical industry, the medical establishment and the herbal industry are more interested in capitalizing on the union of herbal medicine and science by making it more acceptable within their paradigm rather than being interested in being transformed by holistic herbal medicine.
• The regulation of herbal drug quality is thus an area of controversy. Some herbalists opine that herbs of long history of use do not require the level of safety testing as pure drugs. Others favour legally enforced quality standards, safety testing and prescription by a qualified practitioner.
• Thus while herbalists call for a category of regulation for herbal products, some others believe it can be managed through reputation without government intervention at the same time agreeing to the need for more quality testing. Also the legal status of herbal drugs varies from country to country.
• Presently there are shortcomings in currently used standardization methods and a better way of standardization may be a biochemical standardization on the majority of active constituents.
• Many processes of standardization are not standardized. To truly standardize every variable concerning the growth, harvest and preparation of a plant must be controlled. The very many variables related to plants in terms of components, interactions and interdependencies make it impossible to control by merely controlling one or a limited number of active constituents.
• One of the premises of standardizing herbal drugs is that before the availability of standardized herbal extracts, most herbal products were inferior.
• Historically there have been highly sophisticated methods of herbal extraction and processing. They abound in folkloric, traditional Ayurvedic, Chinese and western herbal medicine.
• Some of these methods such as detoxification of aconite by preparing it with salt and/or long boiling decoction are the mainstay of TCM.
• Ayurvedic medicine employed many ingenuous and complex methods of extracting, concentrating and preparing herbs for specific conditions. In this regard, purified guggulsterones are traditionally extracted from crude guggul resin (Commiphora mukul) in a botanical decoction consisting of equal parts of chebulic myrobalan, embolic myrobalan and beleric myrobalan, a formula widely known in India as Triphala.
• Thus it is possible to guarantee optimal levels of all plant ingredients without laboratory analysis by paying attention to the right growing requirements of the plant, best stage for harvest, right time of the day optimum for yielding the highest levels of all known ‘active’ constituents. Other factors such as proper drying and storage are also required to be adhered to. All of this requires training and experience thus making herbal medicine both an art and science.
• For thousands of years herbalists have been using and prescribing herbs both singly as well as in complex formulas with utmost attention to quality. Considering that we know very little not only about the complex chemical compounds they are constituted of, but even less about their synergistic relationship to each other and how they affect therapeutic activity, there is no need to abandon the use of traditional formulas.
• Though standardized extracts can be based on many markers, apart from enhancing the cost of processed herbs, it has little relevance to clinical herbal practice. By the generation of such highly priced and heavily promoted prescription herbal drugs by large herbal drug manufacturers, there may be further devaluation of already demonstrated, quality non-chemically standardized products.
• At this point it is difficult to access the potency and efficacy of these artificially standardized herbal products over whole, non-standardized herbs. While they have very specific applications compared to commercial, non-analysed whole herbal products, they might not always be the best choice.
• Further studies to compare the effect of standardized biochemical extracts with whole herbs or traditional herbal formulations are much needed.
• Thus while high doses of herbs as standardized extracts have their place in modern herbal medicine, they should not displace the use of herbs in other forms.