Gujarat food and drug regulator has issued a show cause notice to a Rajkot-based ayurvedic drug maker, Shukla Ashar Impex Pvt Ltd, for misleading claims on its product as a cure for Covid-19.

The company had claimed that its plant-based liquid formulation product - Aayudh Advance - was highly effective and safe for treatment of Covid-19 patients. It also claimed the product to be first clinically-tested medicine for Covid-19 management and treatment.

The company had launched the product earlier this month and claimed that the Translational Health Science and Technology Institute (THSTI) under the Department of Biotechnology, Government of India had found its formulation to be three-times more effective than antiviral drug - Remdesivir.

The state drug control authority has issued a 7 days’ show cause notice to the company. Deap Shukla, Managing Director didn't respond to the phone calls.

The Union Ministry of Ayush, in a letter to the Joint Commissioner (Ayurved) of the Gujarat Food & Drug Control Administration, had asked Ayurvedic licensing authority of the State to initiate strict action against the company that had made such "misleading claims for its product".

Issued on April 18, by Dr S R Chinta, Deputy Advisor, Drug Policy section of the Ministry of Ayush, the letter cited 5-6 reasons that invite strict action against the company. These included violation of several provisions of Ayurvedic rule book including Section 33 EEB which puts a particular drug in ‘Misbranded, Adulterated and Spurious Drug’ category.” Under the Rule 158-B, the conditions were not fulfilled and “the rule deals with licensing of 3(h) formulation and requires that ingredients should be part of Authoritative Books mentioned under First Schedule.”

The company had claimed that clinical study of the alleged product was referred to different committees, namely, ‘Interdisciplinary Ayush R&D Task Force on Covid-19’ and ‘Interdisciplinary Technical Review committee (ITRC)’. "Both the committees had rejected the product as well as the clinical trial as it did not follow the principles of Ayurveda and study protocols," the Ministry's letter noted.

On the company's claims about plant-based ingredients, the ministry clearly mentions that some of the ingredients in the formulation of the product in question are not mentioned in Ayurvedic classical text as prescribed in First Schedule of Drugs & Cosmetics Act 1940. "Hence it cannot be termed as Ayurvedic drugs under rule 3a & 3(h) (i) of Drugs and Cosmetics act 1940," it noted.

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