March-April 2018 Indian Journal of Pharmaceutical Sciences 325 Research Paper Ayurveda utilizes natural resources of plant, animal, metal and mineral origin in therapeutics of different pathologies. These resources are converted into formulations based upon the need by following specifed classical guidelines. Herbo-mineral and metallic formulations are an important part of Ayurveda that are attributed to be safe and effcacious when manufactured and used judiciously. Rasamanikya, one such metallic formulations, attracted controversies in scientifc community due to the presence of arsenic as an integral component. It is being used by Ayurveda physicians to treat fever (Jwara), cough (Kasa), asthma (Shwasa), fstulous tracts (Nadi Vrana) and skin diseases (Kushtha) [1] . In general, arsenicals are toxic and produce untoward effects on administration [2] . Anticipating such untoward effects; seers of Ayurveda have explained meticulous handling procedures and administration modalities for all such metals and minerals including arsenicals [3] . Importance of following traditional pharmaceutical procedures in preparation of Ayurvedic formulations have been well- established [4,5] . Ayurveda emphasizes on administration of metallic formulations orally in specifed quantities with great caution along with requisite anupana (vehicle) that is anticipated to play a key role in safety aspects of Rasaushadhies. Anupana facilitates drug administration, improves palatability and also reduces toxic nature of the drug [6,7] . Though, there are many Acute and Chronic Toxicity of Rasamanikya, an Ayurvedic Arsenical Formulation in Rats S. Y. CHAUDHARI*, S. BIRADAR 1 , M. NARIYA 2 , R. GALIB 3 AND P. K. PRAJAPATI 3 Research Offcer, National Research Institute of Ayurvedic Drug Development, 4 CN Block, Sector-V, Bidhan Nagar, Kolkata-700 091, 1 Department of Rasashastra and Bhaishajya Kalpana, Sai Ayurvedic Medical College, Sasure Vairag, Solapur-413 402, 2 Pharmacology Laboratory, Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar-361 008, 3 Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, Sarita Vihar, New Delhi-110 076, India Chaudhari, et al.: Acute and Chronic Toxicity of Rasamanikya in Rats Rasamanikya (an arsenical formulation of Ayurveda) contains Haratala (arsenic trisulphide) as an integral component. Concerns are being raised on such Ayurveda formulations with heavy metals in their composition for safety aspects. Though, these are being used safely in Ayurvedic clinical practice since ages without any noticeable untoward effects; there is a need to generate scientifc evidence that these are safe and non-toxic. In the present study, safety profle of Rasamanikya prepared from Kushmanda Swarasa Shodhita Haratala (arsenic trisulphide processed in juice of Benincasa hispida) was evaluated through acute and chronic toxicity studies. In acute toxicity, Rasamanikya was administered at a maximal dose of 2000 mg/kg to overnight fasted rats and observed closely for behavioral changes, signs of toxicity and mortality if any, continuously for the frst six hours and thereafter periodically up to 14 days. In the chronic toxicity evaluation, the drug was administered daily at the doses of 22.5, 112.5 and 225 mg/kg along with honey and ghee as an adjuvant to rats for 90 days followed by a 30-day recovery period. Animals were sacrifced on the 91st day and hematological, serum biochemical parameters and histopathology of organs were studied. In acute toxicity, Rasamanikya at the dose of 2000 mg/kg did not produced any observable toxic effects or mortality. Safety of Rasamanikya at therapeutic and fve-fold therapeutic dose level has been revealed in the chronic toxicity study. Mild to moderate pathological changes on different haematological, serum biochemical and cytoarchitecture of different organs were observed at ten-fold therapeutic dose level. Based on these observations, it can be concluded that Rasamanikya is safe at therapeutic dose levels when used judiciously along with specifed adjuvants. Key words: Arsenic, Haratala, Rasamanikya, safety, Shodhana, toxicity *Address for correspondence E-mail: drswapnilyc13@gmail.com This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms Accepted 13 February 2018 Revised 26 June 2017 Received 29 November 2016 Indian J Pharm Sci 2018;80(2):325-333