ABSTRACT

Ayurveda, Siddha, and Unani (ASU) formulations are made from natural ingredients, some of which have the potential to be toxic. According to the Ministry of Health and Family Welfare’s gazette notification G.S.R.377 (E), dated 3 May 2010, every ASU medicine to be established is secure and without toxicity. Thus, the pre-clinical toxicity regulation is put into effect. The majority of ASU medications are drawn from the literature that is listed in the first schedule or formulation ingredient section 3(a), where it is assumed that the ASU medication or its component is well established. Additionally, new claims for ASU medications must be supported by literature references and experimental data that demonstrate their efficacy and safety. Acute and long-term toxicities, sometimes known as sub-acute toxicity, are the two classes of ASU medicines. The other toxicities, such as genotoxicity or mutagenicity, are also included.