Information on the label, batch numbers, expiry dates and place of manufacture are presented in figure 1. It shows that 46% of the hand sanitizers were not registered with the regulatory body in Nigeria (NAFDAC),66% have manufacturing dates, while 74% had expiring dates. Only 54% of the sanitizers are registered, while 44% did not even have batch number
Figure 2 shows that most (70%) of the hand sanitizers analyzed were locally produced in Nigeria 24% had no country of manufacture on their labels, while 6% were from other countries. It is important for HS to meet the requirements for proper labelling with full information on their packages in order to avoid misuse and accidental use of such products, the possible effects of lack of or improper labeling or package information has been expounded by previous researchers [13, 14].
Figures 3 and 4 show the alcohol content and status of the samples respectively; It can be observed that majority of the samples have alcohol content between 60 to 69%, a few (4%) of the samples had alcohol content of 80%, however, on a general note, most (78%) of the samples failed the alcohol content test, and are therefore unfit for human use.
The World health organization (WHO) report on local production of HS, [8] only 22% of the samples passed as seen in figure 4. It has been reported [14] that low concentrations of alcohols in hand sanitizers is a major challenge, and this has been implicated in their low efficacy and quality. In their report [14], the United states Pharmacopoeia claimed that, out of 200 samples of sanitizers investigated for quality in Africa, 20 (10%)were of low quality; their report is sharply different from our present study, in that, we observed that 78% of the samples we interrogated were substandard, of not however is the fact that, the USP study did not take samples from Nigeria. Our present report is however similar to that reported from another African country, Ethiopia [15], where 70% of hand sanitizers marketed in that country did not comply with the WHO requirement for alcohol content. A similar study conducted in yet another African country of Kenya returned the worst outcome with none of the samples meeting regulatory requirements [13]. The report from Uganda [16] was however excellent, with all the samples analyzed complying with the regulatory requirements for quality. Researchers and quality control experts agree that the efficacy of hand sanitizers is dependent on the concentration of alcohols used, the type of alcohol, presence of inactive excipients, type of formulation, contact time and volume of alcohol used [15 – 17], and the recommended concentration of alcohols in hand sanitizers range between 60 – 95%, this is because, at this concentration, the alcohols interact with the proteins in the organisms to exert its activity. Concentrations between 60 – 75% have been found to denature the proteins in the organisms, while concentrations greater than 95% causes coagulation of the membrane proteins to prevent penetration of the alcohol into the cells of the organisms [16]. It has also been opined that, at80% or more, alcohol evaporate quickly from the surface of application leading to less contact time with the organisms, therefore, excessive amount of alcohol in sanitizers may be counterproductive. It should be noted though that, sanitizers with alcohol levels close to 60% may face the danger of losing its recommended concentration during transportation, handling and shelf-life [8]. Hence, WHO came to the conclusion that, the most appropriate concentration of alcohols to be contained in hand sanitizers for maximum efficacy should range between 70 – 80% [8]. On the basis WHO recommendation alone, 78% of the hand sanitizers marketed in Abuja, Nigeria at this time is substandard and unfit for use in preventing the spread or transmission of covid-19.
“Healthy human skin lies in the pH range of 4 to 6.1. An increase in stratum corneum (SC) pH can disrupt the activity of enzymes involved in keratinization, barrier restoration, and anti-microbial function. This phenomenon is seen in atopic dermatitis and other xerotic skin diseases and correlates with disease severity of dryness, pruritus, and total skin involvement. Chemicals applied to the skin are an important exogenous factor that may stabilize the skin’s acid mantle. Therefore, topical products with near-physiologic pH are considered best in prevention and treatment of these same skin abnormalities” [18]. According to Sayaka et al [19], the skin is usually kept slightly acidic by acidic keratin sebum and eccrine secretions to form a film on the surface of the stratum corneum, but if the pH is increased from normal baseline, the number of bacteria on the skin surface is increased, the types of bacteria change, and transepidermal water loss increases. Therefore, abnormal pH of the skin surface causes the destruction of the skin barrier function; this underscores the need to have sanitizers properly formulated not just with the recommended concentration of alcohol, but pH also. In our study as shown in Figures 5 and 6,
68% of the sanitizers failed. At pH of 7.5, it is reported that, there will be overgrowth of staphylococcus aureus, [20]. It has also been reported that some hand sanitizers cause irritations and allergic contact dermatitis, while others have been reported to cause itching, cracking and peeling of the skin [21].. Overall, sanitizers with unfriendly pH have been implicated in these findings, and 68% of the sanitizers interrogated in this study have questionable pH values. We opine strongly that, besides the inadequate alcohol content displayed by these hand sanitizers, their pH values reveal that they may support the emergence of skin infections. In fact, some of the pH values may equally contribute to instability in the sanitizer formulation [21].
In sub-Sahara Africa where the literacy level is still low, compounded by weak health system and regulatory regime as well as corruption, our study shows that some manufacturers of hand sanitizers took advantage of these lapses to manufacture products of substandard quality with the intention of making profits while endangering the lives of the populace. That substandard hand sanitizers and the use of unwholesome medicines can have a devastating effect on the health of a nation and on the healthcare systems in countries is no longer in doubt [21; 22] For example, it has been reported that, at least, 10% of medicines in sub-Sahara Africa are substandard, accounting for over 30 million Dollars in expenditure. To reverse this trend is a task that must be taken with all the seriousness it deserves; either by way of institutional strengthening, capacity building, increased resource allocation, public enlightenment or deterrent sanctions against offenders [23, 24].