With no government oversight, profiteering industries flood Indian markets with toxic sanitisers
Reports by the Punjab Food and Drug Administration, dated 3 July, which The Caravan is in possession of, revealed that poisonous hand sanitisers have flooded the state and national markets amid a surge in demand during the novel coronavirus pandemic. In tests conducted on 63 samples of hand sanitisers, 36 proved to be of sub-standard quality while four samples had highly toxic levels of methanol, in quantities that could cause permanent blindness, damage to the nervous system or even death, according to the Punjab FDA. The document list out the test results of all the samples that were taken and the companies that manufactured them. “We are talking of an almost epidemic scale of poisoning over the past three and a half months and Punjab is not the only state where this is occurring,” a senior official in the Punjab FDA, who wished to remain anonymous, told me.
Following the announcement of the nationwide lockdown to stop the spread of the novel coronavirus, the health and consumer affairs departments of several states, on the advice of their central government counterparts, gave permission to an unprecedented number of hand-sanitiser manufacturers. The government authorities failed to check if several new manufacturers, many of whom had no previous experience or completely lacked testing equipment, met safety standards for the manufacture of hand sanitisers. Since early June, the Punjab FDA frequently reported that markets have seen a spate of substandard and toxic hand sanitisers to the state’s health and consumer affairs departments and the corresponding union ministries. These reports have frequently been ignored by the government bodies handing out manufacture approvals. The Ministry of Ayurveda, Yoga, Unani, Siddha and Homeopathy—or AYUSH—as well as its state counterparts began giving license for the manufacture of ayurvedic sanitisers which do not fall clearly under the standards set by the Drugs and Cosmetics Act. This made it impossible for FDAs to act against toxic, ineffective and mis-advertised ayurvedic sanitisers.
The spate of ineffective and toxic hand sanitisers has been caused by a range of hasty approvals and announcements made by both central and state governments. In the rush to meet the growing demand in the wake of the COVID-19 pandemic, these governments ignored the usual safety standards and approval mechanisms for pharmaceutical manufacturing. On 13 March, the union ministry of consumer affairs, food and public distribution issued an order titled the Essential Commodities Order, 2020, which added masks and hand sanitisers to the essential commodities list. This order removed the usually strict quotas on manufacturing hand sanitisers, allowing any approved manufacturer to produce as much as they could. This notification was to remain in force for a period up to 30 June.
Kahan Singh Pannu, the FDA commissioner of Punjab, told me that by mid-May, they were receiving news of substandard hand sanitiser entering markets in the state. Many of these samples were evidently of poor quality, often packed in cheap alcohol bottles without dispensers, or were very runny, which indicated adulteration. In mid-June, the Punjab FDA began testing on 63 samples they had seized, only two of which had been manufactured in Punjab, while the rest were brought from outside the state. The Punjab FDA report suggests that 36 of the samples failed their tests, often having alcohol percentages far lower than the 60 percent advised by the World Health Organization.
“Four of these samples had methanol in very high and dangerous concentrations,” Pradeep Kumar, a joint commissioner in Punjab’s FDA, told me. Methanol, a form of alcohol, is highly toxic when ingested or absorbed through the skin. “Methanol is not an acceptable active ingredient for hand sanitisers, at least four samples including one from Punjab and the rest from outside the state were found to have methanol in the range of 35 to 95 percent,” Kumar added.
On 17 June, the USFDA found that nine products, including hand sanitiser, manufactured by Eskbiochem SA de CV, a Mexico-based pharmaceutical company, could contain high levels of methanol. Two days later, the USFDA advised consumers to avoid the product and seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning. According to the FDA of the United States, substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. The USFDA noted, “Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.” The USFDA also asked the company to immediately recall its products.
Pannu told me that the Punjab FDA had attempted to act as quickly to stop the spread of substandard and toxic hand sanitisers, but the scale of the problem in India was much larger. “At least, we have taken a huge number of samples and are testing the same since we have the facilities in Punjab,” he told me. “To think of the many other states, which don’t have the required facilities in their testing labs. New companies are manufacturing hand sanitisers at an unprecedented scale now in all of our neighbouring states, but in Himachal Pradesh and Jammu and Kashmir they don’t even have equipment for gas chromatography, through which we test the percentage of alcohol in hand sanitisers,” Pannu said. Gas chromatography is also essential for detecting methanol adulteration in sanitisers.
Kumar continued, “Out of 63 test reports of samples that we took in Punjab, 25 were found to be not of standard quality and 11 were misbranded.” Kumar added that of these, three were both not of standard quality as well as misbranded. Some samples collected by the Punjab FDA contained over 95 percent methanol.
The usual procedure for drugs licensing was frequently tampered with by the consumer affairs ministry after their first notification on 19 March. The notification also called on manufacturers to enhance their production, smoothen their supply chain. Six days later, the ministry sent a letter to all state chief secretaries demanding that they enhance the production of sanitisers. The letter stated that all instructions from the union ministries regarding production of hand sanitisers need to be addressed on a “priority basis.” The letter added that the issuing of new licences was “Most urgent.” It also reiterated that all quota restrictions on the supply of ethanol or ethyl alcohol to manufacturers were to be removed across the country and states were encouraged to subsidise ethanol to units.
“It was asked that the Sanitizer Industry operating in the States/ UT administrations should be motivated to run their units in all three shifts so that they can utilize their installed capacity to produce maximum quantity of hand sanitizers at a reasonable price,” the letter read. On 21 March, a notification was issued by the ministry which fixed the maximum retail price of hand sanitiser at Rs 100 for every 200 millilitres. The senior official of the Punjab FDA told me that the market ceiling of the price for sanitisers was fixed without any analysing of the costs of quality raw material.
Following these notifications, approvals for sanitiser production were given at a record rate, often without robust mechanisms to ensure that new manufacturers, many of whom were alcohol distilleries or cosmetic manufacturers, would stick to the strict chemical standards required for pharmaceutical manufacturing. On 16 June, Subodh Kumar Singh, a union joint secretary of food and public distribution, sent a letter to the chief secretaries of all states regarding the sheer number of approvals for manufacturing that had been given and the increase in hand sanitiser production.
“Meanwhile due to such ‘sustained efforts’ the production capacity of hand sanitizer could be enhanced to around 30 lakh litres per day and more than 300 lakh litres of hand sanitizer could be produced till that date,” the letter stated. “It has come to the notice of this department that most of the licences were issued for a short period of time and are going to expire by 30th June 2020 … Keeping in view the role of hand sanitizer in this long and hardest fight arduous fight against the pandemic, the Ministry requests the states to issue necessary directions to the Drug Controllers/ Competent Authority of respective states to extend the necessary permission to distilleries/other units manufacturing hand sanitizer for a further period of six months beyond June 2020 till December 31, 2020.”
The senior Punjab FDA official told me that many of these permissions made it very hard for the FDA to function. “See, regularised industries, like pharma and cosmetics, which previously manufactured sanitisers were already under the Drugs and Cosmetics Act and were set up with those stipulations,” he said. “Now they have given permissions to irregularised industries like paints, distilleries and electrical goods plants which have never been under the Drugs and Cosmetics Act and so meet none of those standards.”
Nowhere in any of the notifications of the ministry was it made clear whether the usual tests and raids should be conducted in the new fast-tracked approval process. On 6 July, I spoke to the director of a company that had been manufacturing hand sanitisers in Punjab for ten years. He wished to remain anonymous. He said that the normal approval process for hand sanitisers was long, tedious, but assured the lack of methanol.
“Authorities during the approval process, and during appraisal process ensure that a range of requirements are met,” he told me. “We have to follow the stringent Schedule M requirements that is needed for drug manufacturing. We have to ensure manufacturing areas are ventilated with dedicated air handling units. We have to ensure that all vessels and machinery are clearly marked and clean and get a proper line clearance from authorities before beginning manufacturing. We need to show the authorities that our quality department has approved and documented all raw material and packaging material.” The director said that if these steps were followed there was almost no chance that sanitisers could have any methanol. He continued, “The fact that sanitisers on the market have now been found in the market seriously suggests that some or all of these steps aren’t being followed.”
On 16 April, Jagdeep Singh, the president of the Punjab Drug Manufacturers Association, wrote to Pannu about the flood of poor quality and toxic hand-sanitisers in the market. “Some of the sanitisers were packed in pints and quarts like sharaab”—liquor—“bottles which had no dispenser for hand sanitizing,” the letter read. “Others were turbid obviously because tap water was used.” In the letter, Jagdeep said that the poor quality of sanitisers was because the state had granted express permissions primarily to distilleries and sugar mills who lacked the equipment or technical know-how to manufacture sanitiser. “And obviously, Schedule M of Drugs Act, which is a precondition for grant of license and duly complied by Drug Manufacturers, was also not complied,” Jagdeep pointed out in the letter.
Jagdeep argued that many distilleries had applied for sanitiser manufacturing licences because their businesses were not breaking even and they could make a profit by using cheap and substandard materials for the production of sanitiser. “It is a known fact that Ethyl Alcohol is available with the Distilleries/Sugar Mills which costs around Rs 40 a litre compared to Isopropyl Alcohol costing Rs 125 per litre used by bonafide manufacturers to manufacture Hand Sanitizers,” he wrote in the letter. “It was also known that Distilleries stood shut owing to Covid 19 and that Ethyl alcohol could be used for making Hand Sanitizers instead of Sharaab. But it was overlooked that this Ethyl Alcohol was unfit for pharma use owing to massive Methylene component and that the Distilleries cannot test it before making Hand Sanitizers.” In the letter, Jagdeep added that the low MRP and competitors using cheap but potentially toxic ethyl alcohol had led older, more established manufacturers to switch to the same cheaper alternatives, dropping their previously high-quality standards.
Officials of several states told me they were alarmed at the sheer number of approvals that were given for the manufacturing of hand sanitisers, and feared that most might not have gone through the rigorous studies usually required for approval. Pardeep Kumar, Punjab’s joint commissioner for drugs, said that before March, only six to seven licences for the hand sanitiser manufacturing had been given in the state. “After the COVID-19 outbreak, in a span of just a few weeks, over 65 licences were given, the majority being given to liquor distilleries,” Kumar told me. He also noted that several manufacturers had not received permission and no-objection certificates from Punjab’s Pollution Control Board and the state’s fire department for the manufacture of bulk-packs of sanitiser exceeding one litre, which are highly volatile and inflammable.
Neighbouring Himachal Pradesh had been a major centre of pharmaceutical and sanitiser manufacturing even before the pandemic. “Before the pandemic, there were already between fifty and sixty sanitiser manufacturers in the state,” Navneet Marwaha, the drug controller of Himachal Pradesh’s FDA, told me. “After we were told to expedite production and give licences on a priority basis, about one hundred completely new licences were issued for manufacturing,” Marwaha said over the phone. “We have five licensing authorities in the state so this process could be conducted very quickly. Himachal supplies sanitisers to other states as well.” When asked if the normal oversight processes were conducted before the granting of licences, he said, “If the reports of the samples of the products manufactured in Himachal Pradesh have been found to be not of standard quality, then, strictest action would be taken against these units.”
A few states have belatedly slowed down the granting of licences and even attempted to withdraw them after malpractice by manufacturers was noticed. “Out of the 15 current sanitiser manufacturing units in the state, 13 of them were given licences after the coronavirus outbreak,” Lotika Khajuria, the drug controller of Jammu and Kashmir, told me. “Two of the distillery units located in Jammu, which had been given permission after the start of the pandemic, didn’t manufacture any sanitiser during this period. They have not asked for extensions of licenses, however,” she added. Khajuria said that drugs and food control organisation of Jammu and Kashmir had conducted several raids during the lockdown, often with the support of the Jammu and Kashmir police. “During two such raids, two reduced paints-manufacturing units located in Sopore and Zainakot districts were found indulging in manufacturing of hand sanitisers in violation to provisions of Drugs and Cosmetics Act, 1940. The defaulters shall be dealt strictly as per provisions of Drugs and Cosmetics Act.”
The Haryana FDA, too, had to quickly attempt to stop production and prosecute manufacturers for not meeting standards mere weeks after the state’s ministry of consumer affairs had issued them licenses with very little oversight. “Post the COVID-19 outbreak, more than 50 firms were issued licenses to produce sanitizers, 18 of whom were distillers,” Narendra Ahuja, the drug controller of Haryana’s FDA, told me. Within weeks of seeing reports of sanitisers with substandard quantities of alcohol or the high methanol content, the state’s FDA took samples from 158 companies for testing. On 7 July, Ahuja told me that while all samples had not been tested, nine were already found to be sub-standard and that first information reports had been registered against their manufacturers under several clauses of the Drugs and Cosmetics Act and the Disaster Management Act.
HG Koshia, the commissioner of the Gujarat FDA, said that they, too, had begun widespread testing of hand sanitisers. “As of 21 March, the license to manufacture hand sanitisers had been given to 41 allopathic licensees, 123 cosmetic companies and 64 ayurvedic manufacturers,” Koshia told me. “However, by 6 July, the state has 585 licenced manufacturers of hand sanitiser. This is good in some ways; the state is manufacturing more than 2 crore litres of sanitiser daily for the country. But at the same time test reports are pouring in. We have collected 260 samples so far and have prosecuted four persons who were manufacturing sanitisers without licences.” Koshia said that 60 of the samples that the Gujarat FDA tested failed in having the required ethanol content or were using recycled ethanol.
Since late March, the AYUSH ministry as well as its state counterparts have taken up a larger role in the licensing of sanitiser and disinfectant production, products that were previously not understood to be under their purview. On 2 April, Rakesh Sharma, the director of Punjab’s AYUSH department, issued a letter titled, “Expediting the process for grant of approval/ license/ renewal of license for manufacturing of ASU immunity boosting healthcare products and sanitizers.” ASU refers to ayurveda, siddha and unani.
The letter stated, “Due to COVID 19 outbreak, the need for public use of ASU based immunity boosting products for healthy people and hand sanitizers has been significantly emphasized and their demand has increased manifold. In this regard, some drug manufacturers engaged in or interested to proceed for producing ASU ingredients-based such products have represented to the Central Government about the problems being faced in the States/UTs for grant or renewal of license/approval in the current situation.”
The letter went on to state that the department had permission to license production of ayurvedic disinfectants and sanitiser based on a discussion between Prime Minister Narendra Modi and industry stakeholders. The letter said, “Whereas Hon’ble Prime Minister during interaction with the AYUSH stakeholders via video-conference on 28th March, 2020 inter alia suggested for ASU medicines manufacturers to utilize their resources towards producing essential items like sanitizers and highlighted the impact of traditional practices towards boosting immunity of healthy people to play the important role in India’s fight against COVID-19.”
However, beyond giving licences for production, the AYUSH department did not make it clear what standards manufacturers of ayurvedic sanitisers would be held to. Ayurvedic medication lacks the same rigorous quality testing of allopathic drugs and this has made it incredibly hard for FDAs to prosecute such manufacturers when they falsely advertise claims.
On 2 June, Kumar wrote a memo to Rakesh Sharma, the director of Punjab’s AYUSH department, and DC Katoch, the advisor to the AYUSH ministry, regarding the approval process for ayurvedic hand sanitisers. The memo asked if there were provisions under the Drugs and Cosmetic Rules, 1945 that permitted ayurveda manufacturers to produce high content alcohol based preparations such as sanitisers. The memo noted that several ayurvedic manufacturers had begun selling sanitisers labelled as prasanna—or rectified spirit with 60 percent alcohol and labels that clearly mentioned they were to be used as sanitisers or disinfectants.
These manufacturers had been issued permissions by the state’s AYUSH department and yet, the FDA was not intimated about the standards of scrutiny to govern these products. In his memo, Kumar wrote that while allopathic disinfectants have clear standards, it was not even made clear whether there were any rules under the Drugs and Cosmetic Rules relating to ayurvedic products claiming to be disinfectants. The memo stated, “In case the aforementioned hand sanitizers/ disinfectants/ rubs/gels/ purifiers etc. are not covered under the provisions of Drugs and Cosmetics Rules pertaining to Ayurveda, Unani and Siddha medicines, the appropriate directions to all the State Drug Controllers may please be issued to withdraw the permissions of such preparations with immediate effect and further direct the manufacturers to withdraw unsold stocks from the market to safeguard the health of public in the interest of society.”
When I spoke to Kumar on 26 June, he told me, “Many such ayurvedic preparations are being labelled with the claim that it kills 99.9 percent of germs.” He continued, “There is no specific reference as to what type of germs are being killed by such disinfectants. It is not even clear to us if such manufactures have some back-end study to prove that the product in question is capable of killing 99.9 percent germs.” Kumar added that several ayurvedic manufacturers even have labels which state that the sanitiser kills the novel coronavirus, with no evidence whatsoever to back this claim.
In a letter to Sharma on 25 June, the Punjab FDA repeated the same questions as local markets were flooded by AYUSH brands selling sanitisers that the FDA had no oversight over. The memo requested the director to provide “clarification and copies of relevant rules within two days regarding certain issues pertaining to manufacture of these sanitizers.” The memo also asked the AYUSH ministry if they were allowed by the Drugs and Cosmetics Rules pertaining to ayurveda, unani and sidha, detailed under the Drugs and Cosmetics Act, to approve the manufacturing of sanitisers and disinfectants. The memo also demanded that the AYUSH department send the details of the ayurvedic manufacturers to who had been issued permission to manufacture sanitisers.
The FDA specifically asked how many samples had been drawn by the AYUSH departments inspectorate staff in Punjab and how many of the samples were of standard quality or contained toxic impurities. The FDA also demanded statistics about the number of cases in which legal or administrative action had been taken against substandard manufacturers. When I spoke to Kumar on 10 July, he told me that the central AYUSH ministry had failed to reply to the letters. This has left the Punjab FDA completely unable to act against spurious manufacturers of ayurvedic sanitisers who are not beholden to any standards in the middle of a pandemic.