THE samples of four brands of Remdesivir injection sent by the Drug Inspectors of Food and Drug Administration (FDA) between May 21 and June 16 this year have been declared as ‘Spurious’ as well as ‘Not of Standard’ by the Government Public Analyst, FDA Laboratory (Mumbai) through its reports on July 23 to 27. The analytical reports have found that out of the samples of the four brands, samples of two brands do not give identification test for the presence of Remdesivir means the drug has been missing in these samples. While two brands showing content of Remdesivir on label as 100mg/20ml injection (means 5 mg/ml), had only 0.156 mg/vial and 14.93 mg/vial Remdesivir content instead of 100mg mg/20ml. All these four brands were supplied to hospitals and institutions as they were manufactured for hospitals and institutions only.

 

The Drug Inspectors collected the samples and sent those to Government Analytical Laboratory, as per procedure. The informal reports of the Government Analyst, after analysis, have stated clearly that the amount of drug Remdesivir was not present and/or ‘very negligible’ in the said samples. The analytical report of ‘Remdesivir Antiviral Drug Desrem’ states, “After assay for Remdesivir, the sample does not give identification test for presence of Remdesivir. The Drug is spurious vide section 17-B of Drugs and Cosmetic Act 1940 and rules 1945. The label states each vial contains lyophilised for intravenous is not correct. It should be each vial contains 100 mg of Remdesivir in the form of Lyophilized powder. The label does not state Manufacturer’s name and address.”

 

The sample without any brand name, Manufacturer’s name and address of any manufacturer had mentioned Batch no EW2005A1, Mfg. Lic No/Code No:Code No:G/0013; Mfg. Date/Exp Date as on label (09/2020; 08-2022’. As far as the samples for Jubi-R (Remdesivir for Injection) brand are concerned, the analytical report states, “After assay for Remdesivir the content of the drug is 14.93 MG/vial instead of 100 MG/20ML. The content is very less than permissible limits.” As per the analytical report, the Jubi-R samples mentioned following details: “(Remdesivir Injection 100 mg/20ml) batch no:JBR20037A; MFG. Lic No/Code No: 1/20/2339/MB); Mfg. Date 11-2020, Exp Date 11-2021.” Intact and tallies with the specimen impression of the seal received separately. Manufactured by Jubilant Generics Limited at Thanewad, Ropar Road, Nalagarh, District Solan 174101. The analytical report for Remdac (Remdesivir for Injection) states, “After assay for Remdesivir the content of the drug is 0.156 MG/vial instead of 100 MG/20ML.

 

The content is very less than permissible limits.” As per the analytical report, the Remdac samples mentioned following details: “(Remdesivir Injection 100 mg/20ml) Batch no: VI00098; MFG. Lic No/Code No: G/28A/6096-A); Mfg. Date 11-2020, Exp Date 10-2021.” Intact and tallies with the specimen impression of the seal received separately. Manufactured by Cadila Healthcare Limited. Plot No 3707-3708, Phase IV. GIDC VATVA, Ahmedabad The analytical report for Covofor (Remdesivir Injection) dated July 23, 2021 states, “Four vials of 100 mg/20 ml were received for analysis. Three vials contain clear, colourless solution and one vial containing yellow coloured solution clearly visible to unaided eye in normal day light. As per the analytical report, the Remdac samples mentioned following details: “(Remdesivir Injection 100 mg/20ml) Batch no: HCL21007; MFG. Lic No/Code No: G/28A/6450-A); Mfg. Date 03-2021, Exp Date 11-2021.” Intact and tallies with the specimen impression of the seal received separately. Manufactured by Hetero Labs Ltd, Survey No 171, National highway No 8, Navasari Gujarat, 396424.