Fake hand sanitisers mushroom with skyrocketing COVID demand

With a billion vaccine doses already running in India’s system, it is only the start of a lengthy war against a fatal pandemic, with a lot more that needs to be done to safeguard people. The lack of a treatment or vaccine, along with the contagious virus’s constant and rapid spread, sparked a panic that had only one answer – hand hygiene. Specialists, doctors, scientists and the WHO bigwigs recommended that people wash their hands often. Sanitisers — for anything people touched — has possibly been the only strategy before the vaccines came into the picture.

The partnership between the public and private sectors sparked a surge in sanitising demand. Sanitisers slowly became commonplace. What was previously only found in hospitals and pharmacies, were suddenly flying off the shelves at supermarkets. Consumption touched litres per person. However, certain unforeseen repercussions of the actions taken to fulfil demand have emerged, such as the emergence of counterfeit hand sanitisers on the market. This is a different kind of epidemic and there is a pressing urgency to combat it.

Following the outbreak of the pandemic, India’s demand for hand sanitisers increased by 3,600 per cent, from nine lac litres per annum to 344 lac litres per annum in just a few months. Since manufacturers were unable to satisfy demand, costs skyrocketed. Back-alley operators saw an opening and began selling false and spurious items, which included plastic bottles, fraudulent labels and sanitisers diluted with water or coloured liquids. The Union Government attempted to address some of these issues in March 2020. The following are some of the fast and interim actions that were taken:

• Sanitisers were listed in the Essential Commodities Act of 1955 until 30^th June, 2020. It had price caps of 50p per 1ml or 500p per litre.
• The government released a directive on 19^th March, 2020, asking state governments to increase sanitiser production as soon as possible. Sugar mills and distilleries were also allowed to make sanitisers for three months under the new restrictions.
• The FDA offices were instructed to provide sanitiser-manufacturing permits within three days of receiving applications. Many producers were awarded licences in a short period of time. The licences have also been renewed until December 2021.
• In April this year, the Ministry of AYUSH approved the production of sanitisers by Ayurvedic medicine makers.

The leeway and its effects

Despite the excellent intentions, there were some unanticipated repercussions.

1. To manufacture sanitisers, manufacturing facilities had to demonstrate to the FDA that they had sufficient infrastructure and staff. Many of these firms are suspected of not having appropriate facilities that meet Central Drugs Standard Control Organisation (CDSCO) standards.
2. Most sanitiser producers do not use the Indian pharmacopoeia-grade component isopropyl alcohol (IPA), resulting in non-compliance with the required standards and composition.
3. Cosmetic and Ayurveda firms have begun producing and selling cosmetic-grade sanitisers, many of which are hand cleaners rather than sanitisers as defined by the Drug Act and do not provide the claimed benefit.
4. Unacceptable levels of methanol have been identified in a few sanitisers, and 1-propanol is often used in sanitisers in Indian hospitals. These are poisonous to the human body. The US FDA considers the use of 1 propanol and methanol to be inappropriate, and only IPA and ethyl alcohol are permitted.
5. Anyone can sell sanitisers, which has led to adulterated versions in the market.

Do we want this?

 Needless to add, such goods have more sinister effects, particularly for the naive public who operate in a false feeling of security against COVID 19. They end up injuring themselves, however, because contaminated 1-propanol and methanol-based sanitisers are ineffective and constitute a major health risk. Furthermore, because the CDSCO does not have a standard for ethanol purity, contaminated ethanol is frequently used in sanitisers. Inhaling impure ethanol has been linked to a variety of health issues.

Cutting to the chase

Authorities are working to reduce the dangers of counterfeit hand sanitisers in the market. Here are a few actions that will operate as a strong force against racketeering and the fabrication of fake sanitisers, among many others.

• Many sanitiser producers’ licences are up for renewal in December 2021. According to CDSCO standards, they should only be renewed for units with a proper manufacturing facility. The facilities should be inspected again, and those who do not follow the rules should not be given an extension. The United States Food and Drug Administration (USFDA) has done the same.

The FDA intends to withdraw guidance documents issued in March 2020 that outlined temporary policies for manufacturers who were not drug manufacturers prior to the public health emergency to produce certain alcohol-based hand sanitisers and alcohol for use in hand sanitisers. Under the interim restrictions, firms that manufacture alcohol-based hand sanitisers must stop making them by 31^st December, 2021. Manufacturers can no longer sell or distribute hand sanitisers made before or on 31^st December, 2021 and produced under the temporary guideline by after 31^st March, 2022. Manufacturers that want to keep making hand sanitiser beyond that date can do so as long as they follow the preliminary final monograph for Over-The-Counter (OTC) topical antiseptics and other applicable regulations, such as the FDA’s Current Good Manufacturing Practices (CGMP).

• The CDSCO should establish rules for the alcohol level and purity of alcohol in sanitisers. DFPCL, for example, employs 99.8 per cent pure IPA in its sanitisers.
• Since hand sanitisers are regulated by the Drugs Act, Indian Pharmacopoeia Grade substances (IP) should be utilised in their production. In addition, WHO suggested formulas that are meant for worldwide usage. In India, the same should be supported for both manufacturing and use.
• In hospitals, 1-propanol-based sanitisers should be prohibited, and only IPA (IP) or ethly alcohol (IP)-based sanitisers should be permitted. The FDA has issued a warning against the use of 1 propanol in hand sanitisers.
• Non-drug manufacturers’ hand cleaning goods, such as cosmetic and Ayurvedic medicine manufacturers’ products, do not fit into the sanitiser category and should not be promoted as sanitisers.
• From time to time, the government should disclose a list of producers and suitable hand sanitiser brands so that people may make educated selections when purchasing sanitisers.

At a time like this, sanitiser manufacturers need to be committed to provide the highest-quality goods to its clients while adhering to the best-in-class processes and standards. In hand sanitisers and rubbing alcohols, IPA is the most used active component. For dealing with COVID-19, most globally renowned institutes like the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC) and others have advocated using IPA-based (pharm-grade) hand sanitisers and disinfectants. Sanitiser brands should be tested at reputable worldwide microbiology labs to diagnose its purity and efficacy. The public should also be made aware about the dangers of spurious sanitisers to escape any health repercussions.

Indian sanitiser manufacturers should look forward to contributing towards the Indian government’s Make in India initiative by manufacturing indigenous products, reducing the import bill and generating employment. However, this should also be done responsibly so that public health is not endangered in any way. Spurious sanitisers are a problem, and it is high time that we come together to deal with it.