Acting upon a letter from the Ministry of Ayush, the Joint Commissioner (Ayurved) of Food & Drug Control Administration of Gujarat has issued show cause notice to a Rajkot based Ayurvedic drugs manufacturer which had made misleading claims for its product AAYUDH advance. The company has claimed that its said product is the ‘first clinically tested medicine for COVID-19 management and treatment’. The company has further claimed that its product is three times better than Remdisvir and that ‘AAYUDH Advance starts where vaccines stop’.
The drug policy section of the Ministry of Ayush had directed the Ayurvedic licensing authority of Gujarat to initiate strict action against the company that had made such misleading claims for its product AAYUDH advance.
In a letter issued on April 18th by Dr. S.R. Chinta, Deputy Advisor, Drug Policy section of the Ministry of Ayush, the Joint Commissioner of the Ayurvedic drugs’ Licensing Authority of Gujarat was asked to take strict and immediate action against M/s Shukla AsharImPexPvt. Ltd, Rajkot. The letter cited 5-6 reasons that invite strict action against the company.
The letter from Ayush Ministry pointed out grave misconduct on the part of the company regarding drug formulation related claims. Citing the Ayurvedic rule book, the letter said that the formulation was “violating Section 33 EEB which puts a particular drug in ‘Misbranded, Adulterated and Spurious Drug’ category.” The letter also cited Rule 158-B and said that its conditions were not fulfilled. This rule deals with licensing of 3(h) formulation and requires that “the ingredients should be part of Authoritative Books mentioned under First Schedule.”
It is noteworthy that the clinical study of the alleged product was referred to different committees, viz., ‘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 trial clinical trial as it did not follow the principles of Ayurveda and study protocols.
It is worthwhile to mention that the company has claimed that this product is “..a liquid formulation comprising 21 different types of plant-based extracts. Ayurvedic Scriptures report these ingredients to be effective and safe to be used for human consumption.” To this claim the letter from 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 prescribe 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.
The Ministry had asked for the Action Taken Report by the Joint Commissioner (Ayurved) of the Gujarat Food & Drug Control Administration, acting on which the state authority has issued a 7 days’ show cause notice. It is worthwhile to note that the Ayush Ministry letter had also mentioned that the said drug ‘AAYUDH Advance’ was violating section 33EED for not having the therapeutic value as claimed by the manufacturer causing public grievance.