Brands of Remdesivir and hand sanitisers continue to be on top of spurious drugs

 

 

 

Six brands of hand sanitisers and three brands of Remdesivir have been declared as ‘spurious’ by the Government analyst of Food and Drugs Administration (FDA) during the past 14 days from November 25 to December 7. From June 2021, brands of Remdesivir and hand sanitisers continue to lead in ‘Not of Standard’ drug reports issued by Government Analyst of FDA Maharashtra. ‘The Hitavada’ has been monitoring the public analytical reports constantly since June 2021. In present time of pandemic, the quality and standard of hand sanitisers and highly promoted and hyped drug Remdesivir is a cause of concern, considering the public analyst reports.

 

Unfortunately, no mechanism to take action against these companies had been initiated after declaring these drugs as ‘spurious’ or ‘not of standard’ by the administration. Even no reports of ‘recalling’ the spurious brands have been issued by FDA. The samples of three brands of Remdesivir injection sent by the Drug Inspectors of FDA between May 6 and June 10 this year have been declared as ‘spurious’ by the Government Public Analyst, FDA Laboratory (Mumbai). Almost six months had been taken by the Public Analyst to issue the analytical reports of the samples sent by FDA for analysis. By the time, these brands must have been consumed by public.

 

The analytical reports of sample sent on June 10 was published by FDA on public domain on November 26, while that of samples sent on May 6, 2021 was published on November 25. The analytical reports have found that out of the samples of three brands, samples of two brands did not give identification test for the presence of Remdesivir. This means the main drug remdesivir drug has been missing in these samples. Desram - the brand declared as spurious contained no remdesivir but had only dextrose. While two brands Remdac seized from Buldana showing content of Remdesivir on label as 100mg/20ml injection (means 5 mg/ml), had only 0.56 mg/vial and 0.07 mg/vial Remdesivir content instead of 100mg mg/20ml. Surprisingly, one brand had amoxycillin 94.628 mg per vial and other had 79.33 mg per vial. 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. It is also surprising to note that in the name of Remdesivir the companies had supplied injections of Amoxycilln and Dextrose. The analytical report of ‘Remdesivir Antiviral Drug Desrem’ and Remdec 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.” 

 

Six brands of hand sanitisers declared ‘spurious’ The analytical reports of December 3 have confirmed six brands of hand sanitisers manufactured by one single company declared as ‘spurious’. Each month about 10 to 12 brands are featuring in analytical reports. During lockdown period when the use of hand sanitisers was mandatory, such quantum of ‘spurious’ hand sanitisers has raised doubt in public minds about the quality and standard of sanitisers available in the market.