Covid-19 pandemic has proved boon for some manufacturers of hand sanitizers, disinfectant liquids, antiseptic liquids and other products. The pandemic has resulted in mushrooming of many companies manufacturing hand sanitizers and other products. Now, people are habituated to using hand sanitizers blindly without questioning the quality and standards of the products they are using. It is million dollar question whether the sanitizers we are using are safe or not? After a survey of analytical test reports of Government analyst, Food and Drugs Administration Laboratory in Mumbai and Drugs alerts by Central Drugs Standard Control Organisation (CDSCO), The Hitavada has found that 30 brands of hand sanitizers have been declared as ‘Not of Standard’ by Central as well as State authorities between March 1 2021 and July 30, 2021, in a period of five months.

 

The Hitavada has analytical reports of all divisions of Food and Drugs Administration (FDA) in the state. Here are two examples which show the delay in analysis of hand sanitizers, the quality and standards of the products people are using and lack of any mechanism to recall the ‘Not of Standard’ products. One example is of ‘Bacter Germs Shield Hand Sanitizer,’ the sample of this brand manufactured in March 2020 was collected by Drug Inspector S S Bharde of Nagpur FDA. She had sent to Government Analyst through a Memo No Nag/Top/Rai/124750/MH-MUM and dated 16-3-2020. The sample of one bottle of 100 ml was received to Analytical Laboratory on 19-05-2020 that is after two months. The sample was analysed and report was given by public analyst on 30-06-2021 with no NSQ/Mum/124750/2021 dated 30-06-2021 at 10.24 am.

 

The report says, “The sample does not give identification test for N Propanol (I-Propanol). The sample gives identification test for the presence of Isopropyl alcohol (2-Propanol) and chlor hexidine Gluconate. The sample contains 82.03%V/V Iso Propyl Alcohol. Content of Chlorhexidine Gluconate is less than the permissible limit (i.e.0.0016% W/V which is 0.32 % of the labelled amount) The label does not state Manufacturing Licence No and Name of Manufacturer).” This shows it has required one year and three months for Nagpur FDA to get analytical report for the sample of a sanitiser it had sent for analysis. In an another example of ‘Advanced Hand Sanitizer’ which has a claim to kill 99.9 percent germs has a manufacturing date March 2020 was sent by Drug Inspector S K Deshmukh from Thane on June 10, 2021. Means after one year and three months, the sample of said Sanitizer was sent for analysis. The analytical report for the same was received on July 30, 2021. the report says, “The sample does not give identification test for the presence of Chlorhexidine Gluconate, Chlorhexidine Acetate and Chlorhexidine Hydrochloride. The label on container does not state the composition of Iso Propyl Alcohol and Chlorhexidine in terms of % W/W or % W/V/ Address of manufacturer is not printed on container label.”

 

 

 

From these examples, it is clear how Hand Sanitizers and other disinfectant liquids are being sold in the state as well as in country. When contacted the senior officials of FDA, they said, “A large number of players are manufacturing Hand sanitizers and the market is flooded with them. FDA only collect the sample on random basis. After getting the analytical report, is observed that the batch has been already sold. It is also difficult to recall ‘Not of Standard’ Sanitizers of which the samples were collected.”

 

 

 

 

“There is no data about how to use hand Sanitizers, toxicity of hand Sanitizers, do’s and don’ts for using hand Sanitizers and any information for consumers in public domain available on the websites of Drug Control, CDSCO and Maharashtra FDA. On the contrary, huge information and recall mechanism is available on USFDA website along with the toxicity and allergic reactions of Hand Sanitizers and Disinfectant liquids,” said a health activist.