Almost all of the herbal industries are small scale / tiny scale (99.5%) and do not possess any R&D facilities. Thus, overall there is very little research happening in this sector. There are broadly two types of herbal industry: The first type are those which manufactures only the classical or traditional products which are described in the ancient literature form around 35 percent of the total herbal industry. There is hardly any scope for R&D as such products are beyond the scope of Intellecutal Propery Rights (IPR) and the formulations are already known. The only area of scientific input is validation of efficacy and safety. The second type of herbal industry are the "Patent and Proprietary" industry which manufactures new products which are not described in the classical texts. The little research which is happening, is mainly in the Patent and Proprietary industries.
The majority of the research budget is spent on validation, rather than product development. The kind of research which will really make a difference is unfortunately out of focus in most laboratories. The areas which need urgent attention are standardization, Bioactivity guided fractionation, compatability and synergy studies, mechanisms of action, etc.
The herbal industry which is having difficulty with applied research itself will obviously not focus on basic research. Fundamental research in natural products demands sophisticated equipment and high skilled manpower. Our educational system is also yet to produce the high skilled manpower, he said.
In India, most of the herbal products are categorized as medicines. However, these products cannot be exported as medicines because of the stringent rules and regulations associated with medicines. Thus, herbal companies can export them only as dietary supplements, neutraceuticals and herbal cosmetics. Unlike the Indian market, the export market is not price sensitive. The herbal companies thus choose to work towards dietary supplements rather than prescription based therapeutics for domestic markets.
Further, even though there are a large number of licensed ISM medical practitioners, it is found that majority of the prescriptions are issued by doctors of modern / western medicines. These practitioners are not very knowledgable about herbal medicine. Thus, the large herbal companies choose the route of OTC marketing of their herbal products.
Unlike chemical medicines, herbal products are far more complex and difficult to standardize. The complexity is compounded in validation of poly herbal preparations. The safety and efficacy of herbal products is directly linked with its chemical composition. For a large number of medicinal herbs, the active principles responsible for their pharmacological properties, are not known. Wherever the active principles are known, their content is measured using chromatographic techniques like HPLC / GC. Wherever the actives are not known, validation is carried out using finger printing techniques like thin layer chromatography. For ensuring safety, several other tests are routinely carried out like pesticide residue analysis, heavy metal residue analysis, microbial analysis, etc.
The focus of reserch is generally linked with the possibility of securing Intellectual Property Rights. Unlike USA, India does not allow patents in the realm of "new use of known substances". Herbal research is invariably based on prior ethno-medical knowledge. Thus, it is difficult to obtain patent rights for mono herbal preparations Even though poly herbal formulations are more complicated to work with, these days the trend is to develop products with as few ingredients as possible. Many companies prefer to work with only 2-3 ingredients. This way they can obtain an IPR and yet restrict the complexities of standardization to the bare minimum.
Mono herbal products cannot be equated to individual chemical medicines as the herb or its extract is a complex mixture of large number of individual phytoconstituents. Most of the herbal products contain hundreds of individual phytoconstituents. Whenver a single phytoconstituent is isolated and sold as such, it no longer remains a herbal product. All such products are manufactured and licensed as allopathic medicines. Eg. Digitalin from Fox glove, Taxol from Yew, Artemisinin from Artemisia, etc.
It is true that in western countries products with fewer ingredients are preferred over multi ingredient formulations. In the European Union, new regulations are being proposed to monitor registration of poly herbal formulations. As per recent information, formulations containing more than three ingredients believed to be active will not be permitted. Other ingredients, if present, should be serving the role of flavoring agents only. For a poly herbal formula, it is difficult to establish synergy in the efficacy of the formulations. But there are some published methods to scientifically prove synergy if present. Unfortunately, most herbal companies do not undertake such studies.
In Ayurved, several formualtions contain "bhasmas" which are made with heavy metals. Even though, some of these formulations have been used in India since several centuries with reprotedly "good results", the acceptance of such formulations both in and outside India has been poor. Most allopathic doctors are reluctant to use such products, simply because there is not enough reserch published to prove the safety of herbal preparations containing bhasmas.
Herbal companies, Natural Remedies, believe that there is a need to blend the traditional knowledge with modern science. Since the acceptability of metal preparations is poor, we do not use any such preparations in our formulations. Further, we have put in place stringent Quality Control norms to ensure that there are no heavy metal residues in any of our formulations.
The scientific validation of therapeutic claims will significantly help in export of herbal products. In fact, this is the need of the hour. Apart from generating scientific proof of therapeutic claims, there is a need to generate sufficient evidence on safety, avoid use of objectionable ingredients, standardize the formualtions and develop modern dosage forms.
- The author is a Director-R&D, Natural Remedies, Bangalore