The truth about hand sanitizers
In the rush to provide enough sanitizers at low cost, many non-drug manufacturing companies may have skimped on quality checks
The first time Ravi Veer bought a hand sanitizer, he had no idea what to look for.
“It was in March, just before lockdown," he recalls. The Pune-based insurance company he works at had wanted to distribute bottles of sanitizer among the staff. Veer, a driver and runner at the company, had never used one. “So I went to a medical shop nearby and asked them."
The chemist offered a 50ml bottle labelled “Safe Sanitizer". There were no details of its contents, licence number or of its manufacturer. “But the chemist told me, ‘This is best’. I bought a dozen."
It was a con. Three months on, he’s still bitter about the breach of trust: from the maker and the seller. “Earlier, if the doctor had prescribed a pill of one brand and the medical (shop) gave another saying it worked just as well, I would take it. Not any more."
Veer was among many first-time users deceived in the initial weeks following the covid-19 outbreak in India, a time when demand for personal hygiene products exploded. In 2019, hand sanitizers were a ₹10 crore industry, according to a report by Nielsen India. Its users were mostly from urban areas. Between February and mid-March, the report added, the demand for them on e-commerce platforms rose by 1,400%.
Manufacturers couldn’t keep up. According to a market research report on Statistica.com, half of 8,000 Indian consumers surveyed in March said they couldn’t purchase sanitizers because there was a supply shortage; 26% of consumers were forced to buy brands they weren’t familiar with. The prices too were rising exponentially—some hospital-grade sanitizers (i.e. those with alcohol content over 75%) were selling for up to ₹2,000 a litre. Sensing opportunity, back-alley operators had started peddling fake and spurious products, involving plastic bottles, fake labels and bulk-bought sanitizers diluted with water or coloured liquids.
On 13 March, the Union government included sanitizers in the Essential Commodities Act, 1955, till 30 June. It came with price caps: 50p per 1ml or ₹500 a litre. A week later, it issued a circular instructing state governments to ramp up production “on a priority basis". The new rules allowed sugar mills and distilleries to manufacture sanitizers for three months. The food and drugs administration (FDA) departments were asked to issue licences within three days of receiving an application. On 1 April, the Union ministry of Ayush (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) allowed Ayurvedic medicine manufacturers to produce hand sanitizers as well.
“As per rules, if an application comes to us, we have to go to inspect the facilities," says a senior official at the Maharashtra FDA, requesting anonymity. The process, the official adds, involves inspectors from the state and Central drug authorities and compliance with Schedule M, a clause in the Drugs and Cosmetics Act, 1940, on good manufacturing practices.
But this time, the official says, licences were given soon after a licence fee was deposited, without any inspection of the premises. The facilities had to assure the FDA that they had enough infrastructure and manpower to produce sanitizers. “It was a pandemic, so the government asked us to expedite the process," the official says. “After the pandemic is over, the licence could also be cancelled."
Evidently, the pandemic is far from over. Last month, the Union government extended such sanitizer manufacturing licences until December. At the same time, though, it took hand sanitizers off the “essential commodity" list, effectively removing the price caps. The reason: a surplus of supply.
The hand sanitizers in the market today are qualitatively different from the kind that were available pre-pandemic. “Over 75% of the market is now cornered by non-drug manufacturing companies," says Abhay Pandey, president of the All Food and Drug License Holders Foundation. “You can buy them everywhere: from paanwalas to grocery stores. In the absence of licensing processes, there’s no way of knowing if they conform to quality standards." According to the Drugs and Cosmetics Act, he adds, non-pharma companies can only describe their products as “hand-rubs" or “hand-cleansers", not “sanitizers". “But many are flouting the rules, creating a false illusion of security for millions of users."
Over time, many cosmetic companies too entered the market. What started as a stop-gap measure, adds Pandey, has now become the norm. “If there is a shortage of paracetamol tomorrow, you wouldn’t ask non-drug companies to start making it. So why do it with sanitizers?"
There’s no data in the public domain on how many new companies were allowed to manufacture hand sanitizers during the ongoing pandemic or how many of them were found to be fake or spurious. The Central Drugs Standard Control Organisation (CDSCO) did not respond to Mint’s requests for an interview. But every month the CDSCO publishes a list of drugs, medical devices and cosmetics found “spurious, adulterated or misbranded". In April, nine sanitizers featured on the list. In May and June, none did.
However, this doesn’t seem to reflect the real picture. “Ever since the outbreak, people from every nook and corner started making sanitizers," says Manmohan Taneja, a senior drugs control officer at the FDA in Haryana. “These included companies making ink, paint or anti-rust solution. Many were making sanitizers without obtaining a licence for it."
The Haryana FDA registered 12 FIRs against companies for manufacturing unlicensed sanitizers, making spurious and adulterated products, and for selling at more than the government-mandated price ceiling. Taneja cites the example of a Manesar-based company specializing in anti-rust solutions. Its sanitizers claimed to have 75% ethyl alcohol—as is the norm. But tests by the Haryana FDA revealed it also contained 10% methanol. “Methanol is highly toxic to human body. But some companies used it because it is a cheaper substitute to ethyl alcohol."
It wasn’t an isolated case. On 15 June, the Central Bureau of Investigation issued a nationwide alert: “Instances have been reported in other countries where due to huge demand for hand sanitisers during Covid-19 pandemic, the use of methanol was detected to produce counterfeit hand sanitisers." While nationwide figures are not available, the Haryana FDA alone had reported 10 hand-sanitizer companies with methanol content ranging from 7-95%, by 10 July.
Such cases are rare and should not be used to cast doubt on all new manufacturers, say recent entrants to the industry. Sanjay Khatal, president, Maharashtra State Co-operative Sugar Factories Federation, insists that they must be given credit for helping bridge the wide gap between demand and supply. Sugar mills and distilleries from Maharashtra and Uttar Pradesh—which dominate sugar production in India—added nearly 14 million litres of sanitizer production per day, he says. The industry is equipped to manufacture sanitizers without regulatory oversight. “The WHO (World Health Organization) has listed specifications on how to manufacture sanitizers. Sugar factories and distilleries already have labs for product testing. The chemists in there have the fundamental subject knowledge."
Since the licence rules eased, 112 new sugar factories and distilleries from Maharashtra have received licences, says Khatal. He isn’t aware of any FDA inspections of the sanitizers produced from sugar factories in Maharashtra. Doesn’t that raise doubts about the quality of products? “We self-regulate," he says. “And we understand it’s not just a business but a moral responsibility as well."
“Every coin has two sides," says Sanjay Manocha, a member of the Association of Indian Medical Device Industry. “The government’s decision (to open up the industry) was at the right time or there would have been a severe shortage of sanitizers. But a lot of these companies don’t have the technical know-how to make hand sanitizers of the same quality. Overnight they cannot arrange the experienced chemists. You can google the recipe but how to cook is important."
The removal of price caps can do further harm, he adds. “When someone buys a sanitizer, many choose cost over content. In the past few weeks, I have come across a few companies offering products at such low costs, they aren’t even our manufacturing costs." With no restrictions, reputed manufacturers are likely to revert to the old, higher prices. This might hit the availability and sales of quality products.
There’s a reason for higher regulatory standards for hand sanitizers, says Pandey. “The manufacturing conditions, the quality of ingredients used in the products, all these things determine the efficacy of the products." You can read up on the procedure and yet not be able to manufacture the same quality. “It’s not just about ratio of ingredients," he adds. “It’s about whether they work for you."
FIRST PUBLISHED17.07.2020 | 08:30 AM IST