Coronavirus Outbreak: DCGI cracks down on seven hand sanitiser brands after lab reports reveal substandard quality
Recent tests conducted by the Drug Controller General of India (DCGI) show that many brands manufacturing sanitisers failed to meet basic standards, and made false claims.
With the coronavirus pandemic prompting people to look for various measures to protect themselves, hand sanitisers have been flying off the shelves of late. However, recent tests conducted by the Drug Controller General of India (DCGI) show that many of these brands failed to meet basic standards, and made false claims.
The drug regulator has 'disqualified' hand sanitisers manufactured by seven brands after lab tests showed that they made false claims about ingredients. The disqualification means that the product is of poor quality and cannot effectively kill the virus.
According to guidelines, an effective alcohol-based hand sanitiser should contain between 70 percent and 80 percent of alcohol.
However, as per the DCGI, Alex Hand Sanitiser, manufactured by Voda Chemicals in March 2020 did not meet the required standards. A test conducted by regional drugs testing laboratory, Chandigarh revealed a mismatch between the actual product and claims made on the hand sanitiser pack. A DCGI note providing details of the lab result on 14 May 2020 said, “Alex Hand Sanitizer sample contains 42.45% v/v methanol and 0.875% v/v Isopropyl alcohol whereas the label claims is Ethyl Alcohol IP 70% v/v."
The term ‘v/v’ is used for percentage by volume of alcohol in the product. A hand sanitiser with 70 percent isopropyl alcohol is considered as the best solution to disinfect hands. The US Food and Drug Administration (FDA) guidelines for hand sanitisers suggest that concentration should remain within the specified level of 80 percent for ethyl alcohol or 75 percent for isopropyl alcohol. The World Health Organisation's (WHO) recommended specifications say that hand sanitisers should contain 80 per alcohol and 75% isopropyl alcohol.
Another brand that failed the test is Limon Cello Hand Sanitiser, produced by the same Delhi-based manufacturer Voda Chemicals. The DCGI said: “Sample contains 45.10 percent v/v methanol and 0.283 percent v/v Isopropyl alcohol whereas the label claim is Ethyl Alcohol IP 70 percent v/v.” This brand too was tested at regional drug testing laboratory, Chandigarh.
Another hand sanitiser called ‘Bond Instant Hand Sanitiser’ interestingly did not have manufacturer details, though the pack mentions that it was marketed by ASM Enterprises, Delhi in February 2020. It has also misrepresented ingredients on the pack. The DCGI's report said: “Sample contains 53.05 percent v/v methanol whereas the label claim stated it contains 95 percent v/v Ethyl Alcohol.” The ASM Enterprises is not listed with Ministry of Corporate Affairs.
‘Feel Good Instant Hand Sanitizing Gel’, another brand manufactured by Voda Chemicals in March 2020 with an expiry date of February 2022, also failed the test. The lab report findings said, “Sample contains 47.17 percent v/v methanol whereas the label on the pack claim under ingredients is 70 percent v/v Ethyl alcohol. Isopropyl Alcohol is also claimed on another side of the label.”
A questionnaire sent to Voda Chemicals did not elicit any response. Despite repeated attempts, the Drug Controller General of India, VG Somani could also not be reached for comment. However, an official on the condition of anonymity said the products found substandard during the lab test will not be allowed for sale in the market, since the government is easing restrictions on public movement and poor quality products could seriously compromise human safety.
“Products not containing required ingredients have serious implications on public health. They will not be certified for manufacturing and sale by state licensing authorities. But, in cases where we receive complaints that poor quality products that failed the lab test are being sold in violation of the Drugs and Cosmetics Act, stringent actions will be taken against the concerned company, which may include imprisonment as well as fine of Rs. 10 Lakh or amount up to three times value of the product confiscated by the inspecting authorities,” the official said.
Also, three batches of Viro-Rub Hand Sanitiser Alcohol Hand Rub, manufactured by Gurgaon based Hi Tech International failed the lab test. This company is not registered with Ministry of Corporate Affairs. All three batches were manufactured in March 2020 with an expiry date of March 2024. For the first batch of the product, the lab report claimed: “Sample contains 54.54 percent v/v Isopropyl Alcohol whereas the label claim stated more than 75 percent v/v Ethyl Alcohol. There is also colour variation in bottles from dark blue to light blue." As for the second batch's product test, the lab report said: “Sample contains 08.52 percent v/v Methanol and 54.33 percent v/v of Isopropyl Alcohol whereas the label claim is more than 75 percent Ethyl Alcohol.”
The lab report for third batch of Viro-Rub Hand Sanitizer is alleges serious contradictions in the claims on hand sanitiser pack, as well as misrepresentation by the company. It said: “Sample contains 10.11percent v/v Methanol and 46.1 percent v/v of Isopropyl Alcohol whereas the label claims is more than 75 percent v/v Ethyl Alcohol IP. Colour is not stable and it is disappearing on storage. Few bottles are mentioned marketed by Hi Tech International instead of manufactured by Hi Tech International.”
Similarly, Pure-Handrub Alcohol Hand Sanitiser manufactured in March 2020 by Punjab based Dr. Edwin Lab was found to be sub-standard. Another brand Good Clean Hand Sanitiser with Aloe and Moisturizers, manufactured by JR& Company based in Delhi failed the test. The product was manufactured in March 2020 with an expiry date of February 2023. Both these companies are not registered with the Ministry of Corporate Affairs.
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