The Department of Ayush has recently issued a circular making clinical trials mandatory for all the existing and new ayurvedic medicinal products in the country. A set of guidelines has been already prepared by the Department for the purpose and it plans to implement it from coming April 2012 onwards.
The guidelines are formulated based on CDSCO document on Good Clinical Practices (GCP) for pharmaceutical products. The draft states that these guidelines should be followed for carrying out research in all ASU and traditional medicines inIndiaat all stages of development. Currently, clinical trials on the ASU and TM medicines are conducted by very few companies and institutions according to their own expertise incorporating ayurvedic principles.
These are mainly in the form of confirmatory trials on safety and efficacy of patents and propriety medicines. The government felt the need for bringing an orderly development of this sector for some time now in the wake of persistent demand for documented evidence of clinical efficacy and safety of these drugs from the importing countries.
As a first step, it had undertaken elaborate studies of toxicity and metal content analysis of about 5000 herbal raw materials commonly used by the country’s Ayurveda units. Currently, these raw materials with no uniformity in quality are procured from divergent sources resulting in sharp variations in product efficacy.
Lack of a standardized manufacturing practice and a system of scientific documentation are two fundamental problems faced by this sector from the very beginning. The main reason for this trend is the unorganized character of this industry consisting of mostly small and tiny units spread across the country.
These units have been resisting introduction of any regulatory reforms for years. The move to introduce clinical trials is also being objected to by a section of this industry on the ground that it is not necessary for traditional medicines especially for the ones which are already established in the market for years. This argument is not very convincing and not acceptable to the international market and the regulatory authorities there.
The regulatory authorities of the developed countries are willing to accept the fact that many diseases can be cured and prevented with ayurvedic drugs but they need documented evidence to support this contention. Indian Ayurveda industry is not able to fully cash in on the growing international demand for its products as these countries are insisting on safety of these products, standardisation of raw materials and dosage forms as in the case of modern medicine.