With a billion doses of vaccine already circulating in the Indian system, this is just the start of a long war against a deadly pandemic, with much more to be done to protect people. The lack of treatment or vaccine, as well as the constant and rapid spread of the contagious virus, triggered a panic that had only one answer: hand hygiene. Specialists, doctors, scientists and WHO bigwigs have recommended that people wash their hands often. Disinfectants – for everything we’ve touched – may have been the only strategy before vaccines came into play.
The COVID-19 coronavirus pandemic has been a boon to the hand sanitizer industry. An Arizton Advisory and Intelligence report estimated that the hand sanitizer market has grown 595% since 2019. The question is whether regulation and testing has kept pace with the growth of the industry.
Disinfectants are becoming commonplace
The partnership between the public and private sectors has triggered an increase in demand for sanitation. Disinfectants have slowly become commonplace. What previously could only be found in hospitals and pharmacies suddenly flew off supermarket shelves. Consumption touched liters per person. However, some unintended repercussions of measures taken to meet demand have emerged, such as the emergence of counterfeit hand sanitizers in the market. This is another type of epidemic and it is urgent to fight it.
After the outbreak of the pandemic, India’s demand for hand sanitizers increased by 3,600%, from 9 lakh liters per year to 344 lakh liters per year in just a few months. Because manufacturers were unable to meet demand, costs skyrocketed. Lane operators saw an opening and began selling fake and spurious items, including plastic bottles, fraudulent labels, and disinfectants diluted with water or colored liquids. The Union government attempted to resolve some of these issues in March 2020.
Here are some of the quick and intermediate steps that have been taken:
· Disinfectants were listed in the Essential Commodities Act 1955 until June 30, 20. Prices were capped at 50 pence per ml or 500 pence per liter.
The government issued a directive on March 19, 2020, asking state governments to increase disinfectant production as soon as possible. Sugar factories and distilleries were also allowed to make disinfectants for three months under the new restrictions.
· FDA offices have been tasked with issuing permits for the manufacture of disinfectants within three days of receiving applications. Many producers obtained licenses in a short period of time. The licenses were also renewed until December 2021.
· In April of this year, Ayush’s ministry approved the production of disinfectants by manufacturers of Ayurvedic medicines.
Spurious disinfectants are a problem
Despite the excellent intentions, there were unforeseen repercussions.
a) To manufacture disinfectants, manufacturing facilities had to demonstrate to the FDA that they had sufficient infrastructure and staff. Many of these companies are suspected of not having proper facilities that meet the standards of the Central Drugs Standard Control Organization (CDSCO).
b) Most producers of disinfectants do not use Indian Pharmacopoeia grade isopropyl alcohol (IPA), resulting in failure to meet the required standards and composition.
vs) Cosmetics and Ayurvedic companies have started producing and selling cosmetic grade disinfectants, many of which are hand cleaners rather than disinfectants as defined by the Medicines Act and do not offer the claimed benefits. .
d) Unacceptable levels of methanol have been identified in some disinfectants, and 1-propanol is often used in disinfectants in Indian hospitals. These are toxic 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.
e) Anyone can sell disinfectants, which has led to adulterated versions on the market.
Do we want this?
Needless to say, such products have more sinister effects, especially for the naive public who operate in a false sense of security against COVID 19. They do, however, end up hurting themselves, as disinfectants based on 1-propanol and contaminated methanol are ineffective and pose a major health risk. In addition, because CDSCO does not have a standard for ethanol purity, contaminated ethanol is frequently used in disinfectants. Inhaling unclean ethanol has been linked to a variety of health problems.
To go straight to the point
Authorities are working to reduce the dangers of counterfeit hand sanitizers on the market. Here are some actions that will act as a powerful force against racketeering and the manufacture of fake disinfectants, among many others.
· Many disinfectant producer licenses are due for renewal in December 2021. According to CDSCO standards, they should only be renewed for units with a suitable manufacturing facility. Facilities should be inspected again and those that do not follow the rules should not be granted an extension. The United States Food and Drug Administration (USFDA) has done the same..:
The United States Food and Drug Administration (FDA) intends to withdraw guidance documents released in March 2020 that outline temporary policies for manufacturers who were not drug makers before the health emergency. public to produce certain alcohol-based hand sanitizers and alcohol for use in hand sanitizers. . Under the interim restrictions, companies that make alcohol-based hand sanitizers must stop manufacturing them by December 31, 2021. Manufacturers can no longer sell or distribute hand sanitizers made before or after. December 31, 2021 and products under the temporary directive after March 31. , 2022. Manufacturers who wish to continue manufacturing hand sanitizer beyond this date may do so as long as they follow the preliminary final monograph for OTC topical antiseptics and other applicable regulations, such as current FDA Good Manufacturing Practices.
· CDSCO should establish rules for alcohol level and alcohol purity in disinfectants. DFPCL, for example, uses 99.8% pure IPA in its disinfectants.
As hand sanitizers are regulated by the Medicines Act, Indian Pharmacopoeia (IP) grade substances should be used in their production. In addition, WHO has suggested formulas for global use. In India the same should be supported for both manufacture and use.
· In hospitals, disinfectants based on 1-propanol should be prohibited, and only disinfectants based on IPA (PI) or ethyl alcohol (IP) should be allowed. The United States Food and Drug Administration has issued a warning against the use of 1 propanol in hand sanitizers.
· Hand cleaning products from non-pharmaceutical manufacturers, such as products from cosmetics and Ayurvedic drug manufacturers, do not fall under the category of disinfectants and should not be marketed as disinfectants.
From time to time, the government should disclose a list of suitable hand sanitizer manufacturers and brands so that people can make informed choices when purchasing sanitizers.
In times like these, disinfectant manufacturers must be committed to delivering the highest quality products to their customers while adhering to the best-in-class processes and standards. In hand sanitizers and rubbing alcohols, IPA is the most widely used active component. To deal with COVID-19, most of the world famous institutes such as the WHO (World Health Organization), CDC (Centers for Disease Control and Prevention) and others have advocated the use of disinfectants and of hand sanitizers based on IPA (pharmaceutical grade). Brands of disinfectant should be tested in reputable microbiology laboratories around the world to diagnose their purity and effectiveness. The public should also be made aware of the dangers of spurious disinfectants and only buy reputable brands to avoid any repercussions on health.
Indian disinfectant makers should expect to contribute to the Indian government’s Make in India initiative by making indigenous products, lowering the import bill and creating jobs. However, it should also be done responsibly so that public health is not threatened in any way. Falsified disinfectants are a problem, and it is high time we came together to address it.
(Rajiv Rao, President, Industrial Chemicals, Deepak Fertilizer & Petrochemicals Corp Ltd)
(To receive our electronic paper daily on WhatsApp, please click here. We allow sharing of the PDF document on WhatsApp and other social media platforms.)
Posted on: Tuesday December 07th, 2021 09:38 IST