Pharmacovigilance for safer use of drugs in Ayurveda through Experimental study

Abstract

Background: Heavy metals are used in Ayurvedic medicine since ancient period. Case reports published in national and international journals and news papers regarding heavy metals poisoning after the use of drugs in Ayurveda has created a negative impact on public towards the use of Ayurvedic medicine. On the ground where formulations of Ayurved are targeted to contain high levels of heavy metals, there is urgent need to have pharmacovigilance for these drugs regarding their safety in the treatment. Hence, an experimental study was conducted to assess the toxicity and to identify the factor responsible for the toxicity of the arsenical compounds Rasamanikya which is a very popular medicine used for various ailments.

Methods: Physical and physico-chemical properties of three different market preparations of Rasamanikya were studied by using advance methods (ICP-AES and XRD) and the sample containing highest level of Arsenic was subjected to chronic toxicity study in rats. Hematological and biochemical parameters were assessed at 30, 60 and 90 days and histopathological study was conducted at the end of the study.

Result: All the three samples showed variation in concentration of arsenic and its crystal size. Traces of nineteen other metal compounds were found in all samples other than Arsenic and Sulphur. There were no significant differences observed most of hematological and biochemical parameters up to 60 days in Wistar rats. No significant differences in body weight and relative organ weight were observed. Minimal to mild changes were observed in liver and kidney which were pathologically insignificant.

Conclusion: LD 50 of Rasamanikya may be more than 2000 mg/kg and Rasamanikya is safe for 15 days duration in the therapeutic dose in human beings. Chronic Arsenic toxicity due to Rasamanikya is not possible if it is consumed in therapeutic dose for 10- 15 days. But there is an urgent need of standardization of method of preparation and standardization of contents to prepare Rasamanikya and its use for therapeutic purposes.