No evidence to endorse efficacy: Ayush Ministry asks ASU drug makers to stop use of Aswagandha

Published On 2021-10-13 05:00 GMT   |   Update On 2021-10-13 05:00 GMT

New Delhi: The Ministry of AYUSH has recently directed Ayurveda, Siddha and Unani (ASU) drug manufacturers to refrain from use of Aswagandha (Withania somnifera) leaves, holding that no substantial evidence and literature is available to endorse the efficacy of crude drug or extract of Aswagandha.

In this regard, the Ministry has issued an advisory to All ASU Drugs Manufacturers Associations seeking the manufacturers of the crude drug/extracts, sellers, ASU drug manufacturing companies, ASU drug exporters not to use Withania somnjfera leaves either in crude or extract or any other form for therapeutic purposes under the ambit of ASU drugs as per textual indications or as a food supplements in the name of ASU drugs.

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This comes after the Ministry noted that Ashwagandha leaves are being used by some manufacturers in their formulations.

As per the Ministry, Withania somnfera (Aswagandha) root is widely used drug in Ayurveda, Siddha and Unani (ASU) systems of medicine since ancient period. Ayurveda, Unani and Siddha systems refer the drug as Aswagandha, Asgandh and Amukkura respectively. Further, Ayurvedic Pharmacopoeia of India defines that the Asvagandha consists of dried mature roots of Withania somnfera Dunal (API, Part I, Vol.1). All these systems use roots of the Withania somnfera as useful part in different single and compound classical formulations.

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As such, the use of leaves of Withania somnifera has not been reported in classical texts of ASU systems of medicine. However, some of the OTC formulations of Withania somnifera leaves are available in markets but neither their safety and efficacy is vividly studied nor reported in ASU classical texts, it said.

"No substantial evidence and literature is available to endorse the efficacy of crude drug/ extract of Withania somnifera leaves. Considering this, it would not be appropriate to consider the Withania somnifera leaves as ASU medicine at this stage", the Ministry observed.

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It noted that extensive studies are required to establish the safety and efficacy of leaves of Withania somnifera for different indications. Till then, the usage of leaves may not be considered for therapeutic purpose in ASU systems.

To view the official advisory, click on the link below:

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