Variation of Heavy Metal Content of Market Variants of Ayurvedic Formulation - Lack of Good Manufacturing Practices (GMP)

Abstract

Aim: The present study was conducted to estimate the heavy metal content in samples of Kutazghan Vati (a pill), from three different manufacturers to know about the quality control measures being followed by manufacturers for GMP. The study will also provide a platform for regulatory authorities to tighten the noose and upgrade the industry about high heavy metal levels in relation to international regulations. Methodology: Three variants of Kutajghan Vati coded as A, B, and C manufactured by different leading manufacturers was procured from local market. Heavy metals analysis was done according to AOAC (1995) for non volatile heavy metals. Results: Cadmium content of two variants A and C was within permissible limits where as cadmium content of variant B was 2.98 ppm about ten times higher than the permissible limits of 0.3 ppm set up by WHO and the Ayurvedic Pharmacopoeia of India. The lead content of variant A was 36.33 ppm that was about four times against the permissible value set up by WHO. Despite very low detection limits, mercury and arsenic were not detectable in all the three variants depicting that the formulation were free from these heavy metals. Conclusions: Despite same guidelines issued by same regulatory authorities for production of ayurvedic formulations for permissible limits of heavy metal content, three different manufacturers marketed the same formulation with different heavy metal content which reflects that industry seems to be negligent for maintaining proper quality control. This study suggests that periodic estimation of heavy metals is highly essential for single drugs, raw drugs as well as finished products for quality assurance and safer use of herbal drugs.