The government hasn’t had much control over India’s hand sanitising manufacturers, who have mushroomed amid the COVID-19 pandemic
One product that made its way into most homes across the world, including India, in the wake of the novel coronavirus disease (COVID-19) pandemic, was hand sanitiser. However, there is no database or government website in India that a consumer can refer if s / he desires to know before hand as to which brands are spurious.
Contrast this with the United States Food and Drug Administration (FDA), which has a ready reckoner for its citizens. Relevant information — like which products are genuine and which fake — is just a click away.
But should the absence of evidence be treated as evidence of absence?
The need for putting such information in the public domain was realised recently when the Consumer Guidance Society of India (CGSI) released its report. The Maharashtra Food and Drug Administration (FDA) had outsourced the sampling exercise of sanitisers available in Mumbai, Navi Mumbai and Thane to the CGSI.
Fifty-nine of the 122 samples picked up by CGSI did not comply with the standards mentioned on their respective labels. Twelve were sold without any claims or labels. Five were found to contain methanol, which is not a permissible ingredient for hand sanitisers. They had methanol ranging from 34-63 per cent, depending on the product.
Hardly any guidelines regarding the composition of sanitisers are available on the Central Drug Standard Control Organisation (CDSCO) website. Instead, there is just an image of a document that talks about examples of formulations of hand sanitisers and surgical disinfectants. Some of these formulations were approved in 2009, while the latest approval was given in 2017.
“For our testing, we followed the World Health Organization (WHO) guidelines,” MS Kamath, general secretary of CGSI told Down To Earth (DTE), when asked if he was aware of any Indian government guidelines on hand sanitisers.
Kamath did not mince words while explaining how almost everybody tried to plunge into the business of making sanitisers: “The licences to manufacture sanitisers were given by Maharashtra FDA online. The online grant of licence obviously made the process much convenient.”
The CGSI, that tested the samples in the lab using the gas chromatography method, found methanol in five samples. These samples were of Kivi Herbals, Avon Laboratories, Equinox Industries, Aan Pharma Pvt Ltd and Avadh Engineering Pvt Ltd.
WHO guidelines don’t permit methanol as an ingredient in hand sanitisers. The US FDA has said methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma or even permanent damage to the nervous system or death.
Two formulations for hand sanitisers are permitted under WHO’s guidelines. They can either contain ethanol (96 per cent), hydrogen peroxide (three per cent) and glycerol (98 per cent). The other permitted formulation is isopropyl alcohol or IPA (99.8 per cent), hydrogen peroxide (three per cent) and glycerol (98 per cent).
Liquor tax is not levied on methanol unlike on ethanol. This, Kamath, explained, might be the reason why manufacturers resorted to using methanol, also known as ‘denatured spirit’.
There were two major lacunae regarding the other violation — of not complying with the claims of the label. The sanitisers were found not to contain ethanol or isopropyl alcohol in per cent volume according to the claims made on their labels, when tested.
For instance, one sanitiser named Hanklin contained 49 per cent ethanol while the label claimed 62 per cent. One of the samples of Patanjali too was found adulterated on this ground.
MK Herbal’s Cleanza Hand Cleansing Gel claimed it contained 70 per cent IPA but testing revealed it contained only 49 per cent. Some 122 samples faulted on these accounts.
Kamath said the CGSI had not written to any of the errant companies. He would share the report with Maharashtra FDA, which in turn, would take action.
Out of control
India’s sanitiser manufacturing industry went into overdrive in March. The Union Ministry of Consumer Affairs issued a couple of letters during the month to chief secretaries saying they should ask state drug controllers to expedite providing licences for manufacturing.
The ministry also allowed distilleries to produce sanitisers and if possible, do bottling too. Otherwise, the bottling industry could be approached. ‘Expedite as much as possible’ was the tone of these letters.
The ministry also said the Prime Minister’s Office (PMO) was keeping a watch on the expedition of the process. “PMO is monitoring the progress of this issue; action taken by the state governments / Union territory administrations along with copies of orders issued in this regard may be sent to this department immediately so as to apprise PMO,” a letter issued on March 24, 2020, said.
Thus, while enough zealousness was shown in removing all possible bottlenecks for manufacturing, not much was said about oversight and control.
This resulted in huge growth of India’s sanitiser market. The market was estimated to be worth Rs 43 crore in March, as compared to Rs 10 crore a year ago.
But to believe Mumbai was a one-of-its-kind case would be wrong. Such stories have poured in from across India.
Six persons were arrested in Hyderabad for selling spurious sanitisers in March. In the same month, a fake sanitiser racket was busted in Jharkhand. Delhi shops were found flooded with such sanitisers which did not bear any name.
The joint drug controller of India, PBN Prasad, issued a letter to licencing authorities of all states to check the sale of spurious hand sanitisers. A few state authorities did swing into action.
But did it have a deterrent effect? Mumbai’s report definitely does not answer the question in the affirmative. Sixteen people died in Andhra Pradesh’s Prakasam district after consuming fake sanitisers for which 10 people were arrested. Kolkata police arrested two and confiscated 1,400 litres of sanitisers in August.
Manufacturing was one part of the story. Sale was another.
The Union Ministry of Health and Family Welfare issued a gazette notification on July 27 that selling or stocking of sanitisers did not require a licence anymore.
It claimed that this move was made after it received ‘several representations’ to do so. Thus, the sale of sanitisers was not limited to chemists. Anybody could sell them.
The ministry, as well as the PMO, received another notification that was summarily ignored. The All India Organisation of Chemists and Druggists (AIOCD) wrote a letter to these offices on July 21, warning against such a move.
“Sanitisers also contain chlorhexidine, hydrogen peroxide, IPA, glycerol and ethanol that need to be bought and sold in licenced premises. When the sanitiser is sold from a pharmacy, there is a government machinery to control,” the letter said.
It added if sanitisers were sold on the roads, even the least oversight maintained by state drug inspectors and drug controllers would not exist.
AIOCD general secretary Rajiv Singhal told DTE the letter was not even acknowledged. He said he had also raised these concerns in CDSCO meetings.
Requests for comments from Drug Controller General of India VS Somani remain unanswered.
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