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.