Profiteering amidst a pandemic
By Dilanthi Jayamanne
Although the National Medicines Regulatory Authority (NMRA) is taking measures to register hand sanitisers and ensure quality standards, sources inside the Authority expressed scepticism over the legal provisions available to take action against those that fail to meet these standards.
Sources explained that the NMRA Act, No. 5 of 2015 enacted by Parliament repealed the Cosmetics, Devices and Drugs (CDD) Act, No. 27 OF 1980, which left room for numerous cosmetic products to flood the market, such as skin creams – a majority of which promised to make the dark Asian skin fairer. When the pandemic occurred, there was a sudden influx of hand sanitisers under various brand names and at high prices towards the latter part of March; although hand sanitisers were already available from reputed brands that manufactured hygienic products and toiletries.
This brought about a dire need for regulation, as there was the risk of substandard products being sold to desperate consumers.
However, no action can be taken until the NMRA Act is amended to include Cosmetics and Drugs. Till such time, the NMRA sanctioned parliamentary approval in 2017 to register cosmetics and cosmetic devices under the CDD Act No. 27 of 1980.
With the large number of hand sanitisers now flooding the market, there are serious questions regarding how many of them met the regulatory standards of either the World Health Organisation (WHO) or the Sri Lanka Standards Institute (SLSI).
NMRA sources said that according to the standards identified by the WHO, the formulation containing 80 per cent volume/volume (v/v) ethanol should also have 1.45 per cent (v/v) glycerol, and 0.125 per cent (v/v) hydrogen peroxide. The formulation containing 75 per cent (v/v) isopropyl alcohol should also have 1.45 per cent (v/v) glycerol and 0.125 per cent (v/v) hydrogen peroxide.
Although all hand sanitisers available on the market pledge to “cleanse the hand,” there are also those mainly in gel form which are allegedly mixed with herbal preparations like aloe vera, citrus and citronella. Some of these brands were produced by well-known manufacturers and also claimed to give added benefits to the user.
Additionally, during the height of the COVID-19 crisis in Sri Lanka, a local distillery stepped into produce hand sanitisers under the supervision of the Excise Department for the National Institute of Infectious Diseases (NIID).
The NMRA’s objective, although unable to take stricter legal measures in the regulation of cosmetics, was to provide safe and quality cosmetics to the public. All cosmetics marketed in Sri Lanka, whether manufactured locally or imported, have to be registered in compliance with the regulations published under the authority of these laws (Regulation No 38 of 1984). The objective of registering them under the NMRA was to ensure that cosmetic products in Sri Lanka were safe and not injurious to health, to prohibit the use of certain toxic substances as ingredients in cosmetic products, to ensure that cosmetic products were properly labelled with batch markings and listings of ingredients used.
However, it remains unclear whether hand sanitisers should be categorised under cosmetic products or whether it constitutes a borderline product.
According to an article based on the UK market, hand gels and sanitisers may be a categorised as cosmetics, a biocide or even a medicine. A biocide, according to European legislation, is a chemical substance or microorganism intended to deter, render harmless, destroy or exert a controlling effect on any harmful organism. On the other hand, the decision on a product’s classification should perhaps be taken on a case-by-case basis, depending on the product’s function, presentation and the claims it makes.
If the function of the product is to clean and moisturise hands whilst providing a secondary antimicrobial effect, then the product can be classed as a cosmetic. But if the only purpose of the sanitiser is to kill germs, disinfect and sanitise hands, then the product is a biocide.
However, a product that claims to be for the purpose of preventing specific viruses, such as COVID-19, flu, cold bugs or other named germs, must be categorised as a medicine.
Thus the dilemma arises – sanitisers on the local market could be classified under all three categories, as some of them pledge to kill 99.99 per cent of germs, while there those that contain gel and claim to moisturise hands.
NMRA CEO, Dr. Kamal Jayasinghe however clarified that hand-rub or hand sanitisers had been classified by the NMRA under cosmetic products. He said that although the NMRA Act had repealed the CDDA Act, they had been able to sanction Cabinet approval to utilise legal provisions available in the CDDA Act No 27 of 1980 to register and regularise cosmetics. Accordingly, the NMRA has taken measures to register all cosmetic products, which includes hand sanitisers, and would monitor their quality following registration.
Measures will also be taken to remove substandard products from the market while steps could also be taken to stop production or remove products that have been registered and listed by the NMRA if any of the sanitiser brands reduce the quality of their products having sanctioned NMRA registration, he said.
Dr. Jayasinghe said that the NMRA also had an agreement with the Sri Lanka Customs to release cosmetic products that only receive NMRA approval, therefore curtailing the possibility of substandard hand rubs reaching the local consumer.
However, until the NMRA Act is amended to include cosmetic products and devices, the Authority would rely on the CDDA Act to streamline cosmetics.