The world is grappling under the public health emergency due to Covid-19, and the causative virus is spreading in the bullet pace of late[1]. Although there has been only five confirmed cases of the pandemic disease in Nepal, there is panic among the public that the disease could hit the country hard if there would be significant rise in new cases of infection. As a precautionary measure, the government has placed the whole country in the state of "lockdown", and this move has garnered plaudits from the public.There has been a widespread suggestion that one should adopt measures such as “social distancing” and hygiene to contain the spread of the disease. Avoiding physical proximity or maintaining physical distancing is what it means by social distancing. While constant hand washing with soap and water is ideal to maintain hygiene while stationed at home, a hand sanitizer does all the goods while outdoors.
The number of buyers has significantly increased; the increased demand has caused the shortage of hand sanitizers in the pharmacies and supermarkets and the price too has since skyrocketed. Although there are reports of hand sanitizer being made using locally fermented alcohol, quality control remains an issue[2]. Given even vodka contains only 40% of alcohol, one would question the quality control of the sanitizer thus made as the alcohol-based hand sanitizer should contain alcohol in the range of 60 to 95% as recommended by Centers for Disease control and Prevention (USA). It is also not guaranteed that such homemade sanitizers are safe to use in human skin[3].
The front line health workers in hospitals are in dire need of sanitizer as they are the most vulnerable ones. In this context the government should maximize its resources so that consistent supply of hand sanitizer is made to the health workers and to the public. The Nepali medicine regulatory authority "Department of Drug Administration (DDA)” under the Ministry of Health and Population is an authorized body to regulate the registration of sanitizer manufacturers and to look after the regulation of such products.
In view of this crunch time, DDA has recently published standard guidelines on preparation and registration of alcohol-based hand sanitizers which will guide aspirant manufacturers in future[4, 5]. However, the sanitizer cannot be made available sooner enough for the respite of those health workers and the public.The shrinking imports and limited production capacity it seems of domestic sanitizer making industries suggest an alternative approach might also need to be considered to speed up the availability of hand sanitizers.
DDA can take the reference of United States Food and Drug Administration (USFDA), which has recently published guiding documents in view of the current crisis so that the hand sanitizers are made in line with the World Health Organization (WHO) recommended formula and are made available in enough quantities. Through its provision USFDA has made way for pharmacists to prepare alcohol-based hand sanitizers as per WHO recommendation in the registered pharmacies[6]. It has also given a temporary right for some drug manufacturers to prepare such sanitizers applicable for the duration of the current public health emergency[7].
DDA can make similar provisions in time to urge the pharmaceutical industries and pharmacies to prepare alcohol-based hand sanitizers to fulfill the soaring public demand. The stakeholders may also be willing to oblige as per the current needs. These entities can efficiently prepare and distribute products through their robust supply chain. The price will likely be significantly cheaper compared to the commercial imported products and the government can place a price cap so that the product remains affordable. Exempting value added tax (VAT) for the ingredients will help the price go down further. The ingredients as per WHO include ethyl alcohol (80%) or isopropyl alcohol (75%), glycerol (1.45%), hydrogen peroxide (0.125%) and rest of sterile distilled water or boiled cold water[8].
While pharmacies can procure these items from chemical stores, the pharmaceutical industries generally have handful of such items in shelves. The more than 80 pharmaceutical industries operating in the country are generally well equipped and staffed with experts in this field to produce thousands of bottles of such hand sanitizers[9]. If they have courage and DDA makes way for them, at least the lack of hand sanitizers will not be an issue to help us fight the global pandemic.
Written By: Samrat Baral, Quality Assurance Pharmacist, Chemidrug Industries Pvt. Ltd.