Considering the fact that alcohol-based sanitizer is most effective in sanitizing hands for infection control, health activists have cautioned that ayurvedic and cosmetic hand sanitizers have flooded the market with false claims of prevention from infections like COVID-19. According to state drug controllers, the reason for such rampant sale of inferior products lacking efficacy is because India lacks in testing standards when it comes to ayurvedic and cosmetic hand sanitizers.
State drug control departments have also reported that some small players have also resorted to sourcing low quality ingredients for manufacturing sanitizers with harmful impurities like benzene and toluene among others which can damage skin and do more harm than relief.
“Hand santizers which fall under allopathic or drug category are based on WHO based formula. They are recommended to effectively kill microbes. Ayurvedic and cosmetic companies can sell hand sanitizers with claims that their product can kill microbes. For which effective inspection, sampling and quality control need to be maintained to verify the product. Samples can fail because in India there are poor testing standards for ayurvedic and cosmetic sanitizers. This can attract punishment under Drugs and Cosmetics Act. In Gujarat, we did random sampling of 362 such sanitizers and 14 were found of sub-standard,” according to Gujarat Food and Drug Control Administration (FDCA) Commissioner Dr HG Koshia.
According to All India Drug and License Holders Foundation (AIDLHF) president Abhay Pandey, “Companies have launched their products in the market taking advantage of the COVID-19 situation. Part of the onus also lies with the Central Drug Standard Control Organization (CDSCO) which has directed state drug controllers to issue licenses to as many companies for consistent availability in the wake of COVID-19 situation.”
“A good sanitizer should be destroying 99.999% microbes within 20 seconds, should be safe on skin over long term use and just have a light non-interfering fragrance. While the market is flooded with sanitizers and the only operating term amongst wholesaler’s and retail seems to be “what’s the rate?.” Conversations about efficacy and quality have taken a backseat,” rues Malay Dikshit, CEO Piscium Health Sciences Pvt Ltd.
Piscium Health Sciences is an IIT Bombay incubated startup and its R&D facility is Department of Scientific and Industrial Research (DSIR) recognized. It has developed IPASAFE an isopropyl alcohol (IPA) based hand sanitizer.
“Popular e commerce platforms have over 10,000 sanitizer brands and definitely over 500 of them claiming to be of ayurvedic properties. As long as any sanitizer can prove its anti-microbial efficacy in a matter of 20 seconds (the time it takes to rub your hands with sanitizer) and if the product is skin friendly, the consumer has been delivered value. This is the only thing that matters,” Dikshit explains.
“As per the scientific evidence, hand sanitizer is a good solution to disinfect when you are not able to access soap and water. As per WHO, hand sanitizer works great and is very effective at killing bacteria, fungi and viruses. Even Centers for Disease Control (CDC) recommends using a formula with 60% to 95% alcohol concentration. This high concentration is critical because alcohol acts as a “denaturing agent” that kills or inactivates viruses,” explains Dr Nitin Malekar, microbiologist and healthcare communication expert.
He further adds, “While reading the label, you need to check if the sanitizer has either one of these three active ingredients on the label -ethyl alcohol, isopropyl alcohol, or benzalkonium chloride. I advise to check the brand or product for an assurance of quality.”
According to Ahmedabad based pharma consultant Dr Sanjay Agrawal, “Sanitizer should contain at least 62 per cent alcohol. Sanitizers with lower concentrations or non-alcohol-based hand sanitizers are not as effective at killing germs as those with 62 or more per cent alcohol. Moreover, some companies are claiming immunity boosting hand sanitizer. There is no evidence that sanitizers increase immunity. I always prefer hand washing as compared to using hand sanitizer which may be used either after hand washing or in absence of water and soap as per CDC guidelines.”
Besides this, CDC and WHO guidelines recommend licensing to sanitizer licencee under the allopathic or drug category and not under cosmetic and ayurvedic category, he informs.
Considering the demand for sanitizers, the Union Ayush Ministry had issued a circular on April 02, 2020 on accelerating the process for grant of approval/license or renewal of license for manufacturing sanitizers. Many new firms have rushed to the Union Ayush Ministry to get licenses and started manufacturing sanitizers in the past four months.
“Though this move has encouraged new manufacturers but kept the quality and safety at stake. The sanitizers which are available in the market are not complying with WHO requirement,” pharma consultant Anshu Yadav concludes.
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