The guidelines for good clinical trials on Ayurveda, Siddha, Unani (ASU) medicines and other traditional medicines (TM), drafted by the Department of Ayush has come under sharp criticism from Ayurvedic Drug Manufacturers' Association (ADMA). They believe that the the draft is not relevant to the ASU or TM drugs and in fact it looks more like a replica of the GCP guidelines for clinical trials of pharma products.
Ranjit Puranik, general secretary, ADMA pointed out that as far as ASU drugs are concerned, there is no regulation like Schedule Y for conducting clinical trials. Since clinical trials are not mandatory for the approval of the ASU medicines. The GCP is a first of its kind for the ASU and TM medicines and with its implementation the government aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the ASU medicine and other TM under investigation are properly documented.
In a letter send to the department of Ayush, Puranik conveyed, "In order to bring some uniformity and harmony in the conduct of clinical trials it is necessary to have some guidelines. But the proposed guidelines are very exhaustive and elaborate and impractical in the current situation in the country." It is to be noted that, if the guidelines needs to be followed, all the clinical trials described cannot be conducted as the guidelines proposes exhaustive protocols, SOPs and elaborate documentation.
Currently clinical trials on the ASU and other TM are conducted by few institutions according tot their own expertise incorporating ayurvedic principles. These are mainly in the form of confirmatory trials on safety and efficacy of patents and propriety medicines most of which are made by altering formulations in the approved books adding or removing some ingredients which is based on the concept of reverse pharmacology. Here the trials are on small number of subjects mostly to one centre with few end points involving very primary investigation.
ADMA has urged the Government to re consider the draft since it does not represent the industry for which it was made in the first place. "Industry, institutions and the professionals all will have to be involved in the process of capacity building and gradually brought to the level of the proposed guidelines. A simpler version of the guidelines covering the essential features should be issued which should be impressed upon the sponsors, investigators and participants alike. Only after ensuring that this measures are taken care of, a more elaborate version on the lines of the proposed guidelines should be issued."
ADMA has suggested that the guidelines should be issued in two stages with a gap of about five years. They have also suggested that the first version should be tuned according to the Indian context for approval in the Indian market, whereas, the second version should aim at the global standards encompassing all the features as in the proposed guidelines.
The Department of Ayurveda, Unani, Siddha and Homoeopathy (Ayush) had recently issued a draft gazette notification informing about the guidelines for good clinical trials on ASU and TM. These guidelines are formulated based on CDSCO document on GCP guidelines for clinical trials on pharma products. The draft states that these guidelines should be followed for carrying out all ASU medicines and other TM research in India at all stages of drug development, whether prior or subsequent to product registration in India.