I am sure all of you would have the same encounter I had recently. Throughout the initial periods of the pandemic, I went to the store, and the pharmacist stated before I even spoke “We are already out of masks as well as hydro-alcohol gel.”
What’s behind this scarcity? Production and flooding of such hydro-alcoholic gels ought to be fairly straightforward.
There is, of necessity, the actual manufacturing cycle, and challenges in obtaining sufficiently raw material. Yet alcohol is a growing drug. Many of you might have seen vodka manufacturers donate distilled spirits to disinfectants.
Extended Authorization Method
In several OECD countries, hand sanitizers and surface disinfectants are controlled goods. Companies intending to market disinfectants must receive a drug authorization. For instance, all disinfectants are restricted in the EU under the Biocidal Goods Law, and the Federal Insecticide, Rodenticide, and also Fungicide Act governs surface disinfectants in the USA, whilst non-prescription products items are governed by hand sanitizers. The purpose of all these laws is ensuring such goods are not only healthy for the customer to use but still function well and perform as stated on the packaging.
Nonetheless, requesting a permit requires rigorous monitoring which may be quite expensive, particularly in terms of safety concerns. The estimated expense of the trials for a potential biocidal active drug is about EURO 5 million. This can seem big, but stuff will quickly go bad without certain forms of supervision and eventual compliance.
For starters, disinfectants for air humidifiers were marketed in Korea between 1994 as well as 2011. Such devices have been engineered to minimize bacterial growth in air humidifiers’ water and thus the growth of microbes generated by the water vapor, preserving the health of customers. However, it was discovered that the disinfectant main substance was not adequately proven to be safe, killing over 100 people and injuring several hundred more. Since then, Korea has considerably enhanced its laws and regulations upon these products.
Although disinfectants may be dangerous if they are toxic for health or the environment, they must be successful in killing pathogens which poses a risk to human health. When they are not successful, their usage can have drastic implications. Think what if a disinfectant used throughout health care facilities was not adequately checked for its effectiveness!
Of course, once the active ingredients in disinfectants have been approved, it would be much affordable to get permission for products that contain them. Thankfully, many of the active materials needed to manufacture virus-efficient disinfectants and hand sanitation agents have already been licensed. For certain nations, for example, ethanol as well as isopropanol are approved for the active components of the hand-sanitizer formulations suggested by the World Health Organization.
Emergency Protocols During the Time of Crisis
Many nations have initiated emergency protocols to accelerate the mechanism in reaction to the growing number of demands for authorization of additional disinfectants during the COVID-19 crisis. For instance, the EU has introduced an emergency process of producers that require clearance for the use of substitute sources of active substances, or for producers wanting to sell goods with novel active substances.
Specific regulations have been set in motion by the US Environmental Protection Agency and for hand sanitizers by the US Food and Drug Administration. Such emergency measures are successful and the number of goods accepted grows every day.
What Will Be Next and What Becomes of The International Partnership?
Knowledge gained: Countries with the case of emergencies disinfectant and other biocidal legislation in place will take stock after the COVID-19 crisis as well as evaluate just how much the regulatory process for addressing the crisis is handled. You should change the legislation accordingly. The sharing of these “learned experiences” between countries would be critical to implement common practices and offer guidance to countries adopting similar law structures.
Further harmonization among countries: global pharmaceutical companies are simultaneously seeking to market their substances in several countries. The further the procedure and specifications are identical in all nations, the quicker new products will be tested for effectiveness and protection and placed on the foreign market.
For example, although the OECD recommendations on checking the effectiveness of hard surface disinfectants are in force, further joint activities are required to expand this to other applications. In addition, customers want to learn if a drug is productive for a certain form of bacterium or virus, such as the one responsible for COVID-19.
In the second case, an OECD-wide program is in effect to enable countries to recognize the protection test results of each other. Nevertheless, no comparable scheme occurs where countries recognize reciprocal disinfectant or other biocidal authorizations. Nevertheless, research has started to encourage the sharing of permit dossiers between countries. In order to improve confidence in joint authorization decisions, this method of sharing the findings of the analysis can be broadened to other areas of the files (both health and effectiveness issues included).
Summarizing, the ongoing COVID 19 crisis indicates that greater international coordination is more desperately required than ever to ensure the health and effectiveness of disinfectants and other biocides worldwide. The OECD Biocides System offers the platform for such collaboration and the ability to do so.
Disclaimer: The views expressed in the article are the author’s own and do not necessarily reflect Dunya News’ editorial stance.