Flouting norms, allopaths conducted ayurvedic drug trials
INDORE: Tossing the Indian Council of Medical Research's (ICMR) ethical guidelines out of the window, allopathic doctors in Indore and eight other cities in India had put scores of patients under clinical drug trials for ayurvedic and herbal remedies.
Two city-based doctors had carried out this trial for the drug manufacturers, in their private clinics in Indore, others did it in several parts of the country. The drugs involved were an ophthalmic medicine, Opthacare, and a novel herbal molecule.
The trials were done on patients reporting with chronic conjunctivitis migraine. As many as 116 patients were tested with Opthacare and another 214 patients were given the herbal molecule by allopathic doctors, across nine cities of country.
The issue had first come in to notice after Congress MLA Pratap Grewal raised a question in the MP Assembly asking for information on herbal medicine clinical trials conducted by allopathic doctors. In response, Chief Minister Shivraj Singh Chouhan had said that 116 patients were put under trial for herbal eye drop Opthacare by allopathic and government doctors. As the trial was conducted at private clinics, no answer was provided in the assembly whether ICMR guidelines were followed or not.
Significantly, the trials did not include any competent Ayurveda, Siddha or Unani physician as a co-investigator in the entire process. This is expressly required by ICMR guidelines, which say that any allopathic doctor conducting any clinical trial using an Ayurvedic or other herbal drug on patients guidelines should have a co-investigator from those disciplines.
This is what the ICMR guidelines say : It is essential that such clinical trials (using Ayurveda or herbal drugs) be carried out only when a competent Ayurveda, Siddha or Unani physician is a co-investigator.......... It would neither be ethically acceptable nor morally justifiable, if an allopathic physician, based on references in ancient literature of.....traditional systems of Medicine, carries out clinical evaluation.. without any concept or training in these systems of medicine. Hence, it is necessary to associate a specialist from these systems and the clinical evaluation should be carried out jointly by following the outcome parameters prescribed in each system.....''.
Terming such clinical trials illegal and an act of quacksery, ayurveda doctors are angry. Dr Mahesh Gupta, state president, National Integrated Medical Association (NIMA) pointed out : , "Allopathic doctors lack any knowledge of herbal remedies and medicinal plants"