Six samples of Favipiravir brands found spurious By Rajendra Diwe : Analytical report of Favimax manufactured by non-existing co and sold through on-line pharmacy n Favimax 400 (Favipiravir Tablets 400); three samples of Batch No TP0521910; and one sample of batch no TP 0421907 and one sample of batch no TP0920782 Mfg Lic No S-MB/99/12; Mfg date 05/2021; Expiry date: 04.2023 Manufactured by Max Relief Healthcare Village Anji Solan Himachal Pradesh-173212. Analyst Remark: The sample does not give identification test for the presence of Favipiravir; the drug is spurious vide Section 17B of Drugs and Cosmetic Act 1940 and Rules 1945. n Favimax 200 (Favipiravir 200 tablets); Batch no TP 0421901; Mfg Lic no S-MB/99/12; Mfg Date 04/2021; Exp date 03.2023 Analyst Remark: The sample does not give identification test for the presence of Favipiravir; the drug is spurious vide Section 17B of Drugs and Cosmetic Act 1940 and Rules 1945. FDA raided the premises of three depots where the stocks of Favipiravir brands - Favimax 400 and Favimax 200 - were stored. The brands of non-existing companies are being sold through on-line pharmacies to wholesalers doctors hospitals in the State The six samples seized by Maharashtra FDA in the raids on three premises in Mumbai were found spurious by public analysts after lab analysis. According to a source from FDA “As per a confidential report the two brands Favimax 400 (Favipiravir Tablets 400) Favimax 200 (Favipiravir Tablets 200) are being sold on-line to the customers across the country. Huge stock of this drug has been stored in three premises in Mumbai. As per the demand the same has been distributed across the country in general and in Maharashtra in particular.” The Maharashtra FDA got a tip-off that the on-line sale of Favimax had increased. According to the on-line sites “Wholesalers suppliers exporters doctors CROs comparator supplies hospitals MOH tender supplies generic brand corporate sourcing institutional buyers should contact the company for purchase of these brands.” The sites stated “The price of this 400 mg brand of Favimax 400 for 10 tablets is quoted on site as Rs 1290 and if anyone wants to purchase in bulk the company offered 15% discount and could get it for Rs 1096.50” an FDA official told. The information was given on website as “Trade Name: Favimax-400 Tablet is an anti-viral medicine used to treat mild to moderate COVID-19 disease under emergency conditions. It contains Favipiravir as an active ingredient. It works by inhibiting the replication of infection causing virus. You should avoid taking this medicine if you are pregnant breast feeding suffering from any liver or kidney problems or are allergic to it.” FDA officials conducted raids on the three premises where the stock of this brand was found. The officials found stock of Favipiravir tablets Favimax 400 mg Favimax 200 mg and Hydroxy Chloro Quine Tablets M HCQ 400 Tablets manufactured by M/s Max Relief Healthcare Village Anji Solan Himachal Pradesh-1730212 and marketed by Covalent Healthcare Kolkata. The stocks were seized from three premises i.e. Shivsrushti Surgimed Mumbai Nirav Trade Link Mumbai and Meditab World Wide Kandivali east Mumbai suspected to be spurious. Samples were drawn for test and sent for analysis. The samples were sent by FDA on May 25 and it asked a public analyst to give report on urgent basis. The Government public analyst has given the report on May 31 and all six samples of Favimax tablets were declared as spurious. All the Joint Commissioners in all divisions of FDA including Nagpur division have received letters from Maharashtra FDA to stop the sale of this drug with immediate effect. FDA official said “It is learnt from Drug Controller Himachal Pradesh that said manufacturer firm was not in existence. Said product has been distributed by Shivsrushti Surgimed and Meditab World Wide to various drug dealers in the State. FDA stated “All Joint Commissioners (Drugs) are requested to stop the sale of said drug immediately. Recall it and send back to concern wholesaler under intimation to JC HQ and JC GB. Please treat this as urgent. All are also requested to verify and make Favipiravir tablets of other manufacturers available. Action taken in the said matter may be intimated to this Office.”

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