Though the Government authorities have made use of masks and hand sanitisers mandatory to contain the spread of COVID-19, the quality and standard of both masks and hand sanitisers remain a big question. Entire market is flooded with a large number of brands of masks and hand sanitisers. It is very difficult for the controlling authorities like Food and Drugs Administration (FDA) to check and control the quality of hand sanitisers. The analytical reports from Central Drug Testing Laboratories and State Drug Control Laboratories month after month have raised a big question over the quality and standard of the sanitisers used.
Recent analytical report of 11 samples of hand sanitisers sent by State Drug Control and Central Drug Control Authorities revealed that they have failed the test. Out of these, four samples were declared as spurious while six samples as ‘Not of Standard’ quality and one sample as ‘misbranded’.
Here are some classic examples of how much period has been spent after sending the samples for analysis and getting analytical report for the same. A sample of one brand ‘Aarush Lavender Fragrance Hand Sanitizer-5ltr’ (Batch no DVVG2727; Mfg Lic Code GC/SM-FC01319RJ; mfg date 10-2020; Exp:10-2020) was sent by FDA officials for testing on December 2, 2020. The analytical report saying the sample ‘as spurious’ was sent to all divisions of FDA on May 12, 2021 with a note by Government analyst to destroy the sample. This means, it took almost 6 months for the Government analyst to declare the sample as spurious and by the time, entire stock of the sanitiser must have been sold in the market.
Another brand of hand sanitiser is ‘3A Handset Hand Rub Liquid’ (batch no HRL-04; MFG LIc No/Code NO KD/C 429; MG date 8-2020 exp. date best before 2 months). The sample was sent for analysis by FDA official on September 4, 2020. The Government analyst declared the sample as ‘spurious’ on May 20, 2021. This means a period of nine months required for Government machinery to declare the sample as spurious as the sample does not give identification test for the presence of Isopropyl Alcohol.
The sample of one ‘Purest Advanced Hand Sanitizer’ (Batch no G 58; Mg Lic No/Code No MP/25D/20/730 Mfg date 11-2020, exp. date:10-2023) was sent for analysis on January 14, 2021 and FAD received the analytical report of the said sample as ‘spurious’ on May 27, 2021 means after five and half months.
The Hitavada is in possession the analytical reports from Government analyst of all these 11 samples failed in analysis. In the COVID-19 lockdown, the markets are flooded with a large number of brands of hand sanitisers. Out of them a very few samples are being collected randomly by the officials. And there is no mechanism for a common man to know about the quality and standards of the hand sanitisers. Surprisingly, all hand sanitisers available in the market are claiming ‘Kills 99.9 percent Germs’ on label. The analytical reports have raised one question as: If these hand sanitisers are lacking in even basic ingredient of it, then what is the purpose of using it regularly? Similar shocking reports have been received from Central Drug Testing Laboratories across the country. CDSCO has sent drug alert report for April 2021.
According to the report, “CDSCO officials had sent 1572 samples of drugs to Central testing laboratories placed in different parts of the country. Out of which 1553 samples were declared of standard quality. 18 samples failed in analysis and out of them seven samples of hand sanitisers failed and declared as Not of Standard Quality.” Both the analytical reports of state as well as central drug testing laboratories have confirmed, “The manufactures have failed to follow the norms of production of hand sanitisers. The manufacturers have not followed the standards and guidelines given by WHO for the manufacture of hand sanitisers. WHO has recommended use of two types of alcohol in two types of formulations. A manufacturer can use Ethanol but that should be 80 % v/v or Isopropyl Alcohol 75% v/v. The hand sanitisers should not contain only alcohol but they should have glycerol 1.45% v/v, hydrogen peroxide (H2O2) 0.125% v/v.
