Samples of two brands of Remdesivir injection fail in analytical test

 

 

 

Government Public Analyst, Food and Drug Administration (FDA) Laboratory, Mumbai, has declared the samples of two brands of Remdesivir injections as ‘Not of Standard’. Drug Inspector of FDA, Nagpur, had sent the samples to the lab on May 6 this year, when allegations of black-marketing of Remdesivir had surfaced during COVID-19 second wave. The analytical report has found that the samples of RemWin and Covifor, the two brands showing content of Remdesivir on label as 100mg/20ml injection (means 5 mg/ml), had only 1.55 mg/ml and 0.78 mg/ml Remdesivir content instead of 5 mg/ml.

 

These samples were sent by Taji S F A Khalil, Drug Inspector, FDA, Nagpur Division. Both these brands were supplied to hospitals and institutions as they were manufactured for hospitals and institutions only. FDA collected samples of the above-mentioned two brands from Sakkardara police station. The Drug Inspector collected the samples and sent those to Government Analytical Laboratory, as per procedure. The informal report of the Government Analyst, after analysis, has stated clearly that the amount of drug Remdesivir was ‘very negligible’ in the said samples. The analytical report of RemWin brand samples states, “After assay for Remdesivir, the content of the drug is 1.55 MG/ML instead of 5 MG/ML. The content is very little.” The samples of this particular brand mentioned ‘(Batch no GTBE015A, Mfg Lic No/Code No:13DR Loan/2020; Mfg Date/Exp Date as on label (28-12-20; 31-08-21)’. RemWin was manufactured by Syngene Intl Ltd at Kokjhar Mirza, Palashbari Road, Palashbari, in Kamrup district in Assam. As far as the samples for Covifor brand are concerned, the analytical report states, “After assay for Remdesivir the content of the drug is 0.78 MG/ML instead of 5 MG/ML.

 

The content is very less than permissible limits.” As per the analytical report, the Covifor samples mentioned following details: “(Remdesivir Injection 100 mg/20ml) batch no:REmi21012A; MFG Lic No/Code No: 21/MD/TS/2014/F/G (L); Mfg Date 04-2021, Exp Date 12-2021.” The red cap of the sample was ‘embossed as Taxim Alkem. manufactured by Hetero Lab Limited, India at Aspiro Pharma Limited, India.’ RemWin samples had manufacturing date of December 28, 2020 and were collected on May 6, 2021 -- that is, after six months from manufacturing -- and the analytical report was received on July 8, 2021. This means that in eight months, the same batch might have been consumed by the hospitals/institutions. Similarly, Covifor samples had manufacturing date of April 2021. The analytical report was received on July 8, that is, four months after collection of the samples. There is no mechanism to know where these injections were utilised or consumed, said a health activist.