Ayurveda formulations: A roadmap to address the safety concerns

Abstract

It is a matter of serious concern that the number of case reports pointing at a possible association between the clinical toxicity and the use of Ayurveda formulations is increasing significantly over the years in scientific medical literature. Though most of these cases are connected with the presence of heavy metals such as lead, mercury and arsenic in these formulations, there are also reports suggesting toxicity due to the presence of toxic chemicals of herbal origin. In the year 2008, the Government of India took an initiative of establishing the National Pharmacovigilance Programme for Ayurveda, Siddha and Unani drugs in a structured way. However, due to lack of sustained support, this program has now become defunct. This issue is of vital importance and needs to be addressed effectively on a priority basis. In this communication, we propose the following crucial policy interventions to be introduced at different levels: a. Amendments to Drug and Cosmetic Act, b. Issuing consumer guidelines, c. Issuing prescription guidelines, d. Issuing clinical monitoring guidelines, e. Implementation of good manufacturing guidelines, f. Promoting documentation of clinical safety, g. Identifying the sources of contamination, and, h. Provision for stringent punishment. If these policy interventions are taken up and implemented, a significant positive change in the scenario can be expected in the near future.

Chemical Compositions of Metals in Bhasmas and Tibetan Zuotai Are a Major Determinant of Their Therapeutic Effects and Toxicity

“…The National Pharmacovigilance Programme for Ayurveda, Siddha, Unani, Tibetan, and Chinese medicines have been proposed in India [103] and in China [11] to address the efficacy and safety, including the regulation laws, the consumer guidelines, prescription guidelines, clinical monitoring guidelines, and implementation of good manufacturing guidelines [74, 103, 104]. Clinical efficacy is of utmost importance as exemplified by the use of arsenic sulfide in combination with other drugs in the treatment of acute promyelocytic leukemia [90].…”

Ayurveda formulations: A roadmap to address the safety concerns

“…I read with great interest the article by Patwardhan K et al. on ‘Ayurveda formulations: A roadmap to address the safety concerns’ [1] . The article genuinely tried to revive an old unsettled issue pertaining to the safety of Ayurvedic formulations, although such attempts are always found short lived surfacing only as a startled response reacting to a finger pointing out something fishy in the system.…”

Cutaneous Adverse Drug Reactions to Polyherbal Formulations - A Retrospective Study

“…In India AYUSH, a Government undertaking established in 2013, encompassing Ayurveda, Yoga, Unani, Siddha and Homeopathy, has started regulating Ayurvedic companies for quality control and standardization of herbs, improving research and development and the availability of raw materials, and monitoring the education standards of Ayurvedic colleges. 19 However, the protocols for quality control in terms of the purity, shelf life, and efficacy of the medicines needs to be perfected. Given that a vast majority of the population in India still depend on PHF for various ailments, the paucity of reports of adverse drug reactions to them is surprising and suspicious.…”