Health research body blasts MBS for alleged unprofessional handling of PressCane Ethanol

Health and Civic Research Institute (HACRI) Limited has lambasted the Malawi Bureau of Standards (MBS) for alleged unprofessionalism in the way the national standards body addressed concerns from the institute on the use of hand sanitizers from PressCane Limited.

HACRI is contending that that the hand sanitizers PressCane is producing does not meet Malawian standards based on study done in the South African Laboratory, which established that PressCane ethanol has 140 parts per million of methanol (0r 0.014%).

Apparently, the ethanol can only be deemed fit for Malawian consumption if it does not have methanol.

This prompted HACRI to pen MBS to express its concern regarding this issue and requesting that the actual content of impurities in the PressCane product should be determined in a transparent and impartial manner.

In its letter to the MBS Director General Dr. Moses G.P. Chisale dated 10^th November, 2021, HACRI suggests that the Pharmacies and Medicines Regulatory Authority (PMRA) Regulatory Requirements for Hand Sanitizers should specify “Food Grade Alcohol” only for hand sanitizers.

“The basis for this requirement is that given widespread, repeated and prolonged use of hand sanitizers on the skin for a long time, as it currently the case, the possibility of toxic accumulation of harmful impurities through skin absorption is very high; and, the widespread presence of hand sanitizers in homes and workplaces owing to the Covid-19 pandemic, means that accidental or misguided intended ingestion of hand sanitizers by children and adults is highly likely in this environment. Also hoping that this is within the mandate of the PMRA, we further suggest that all non-food grade alcohols produced on the local market should be denatured with bitrex,” reads the letter, which HACRI Board Chairperson Dr. Yohannie Mlombe and his Board Secretary Dr. Charles Dzamalala signed.

In their report compiled earlier, Mlombe and Dzamalala warned that methanol poisoning is difficult to diagnose even in developed countries and in Malawi it will be very very difficult to diagnose methanol toxicity (or other ethanol related toxicities) when there are no clinical laboratories that can routinely test for methanol and other ethanol impurities.

They said given that ETHCO makes food grade alcohol and the company has not indicated that they do not have capacity to meet the needs for hand sanitisers on the local market, there is no justification to risk the health of Malawians and allow ethanol not fit for human consumption and/or its products to be freely available at community levels, including in people’s homes and work places.

“PRESSCANE did not cooperate with us which hinted at unethical tendencies with their products. Since they are using industrial grade ethanol to make a hand sanitiser, it is very conceivable that they are using the same for beverages or they are deliberately turning a blind eye to the same thereby putting the lives of the population at risk perhaps in the pursuit of profits. Ethanol products that are not fit for human consumption but available at community level, as is the case with RS from PRESSCANE, should be denatured,” Mlombe and Dzamalala recommended.

In response, MBS recently issued a press release in which it dismissed the results of the Mlombe and Dzamalala.

The Bureau indicated that their results from a contrary lab test showed no impurities for rectified spirit are also concerning as to whether they were genuine results or they were unreliable results from an incompetent or from a corrupt laboratory.

But this has not gone down well with HACRI Limited, which says the press release is devoid of substantive information.

“Is the MBS Director General saying that Presscane Ethanol is safe for human consumption? Should Presscane Ethanol be used for beverages? Is MBS against denaturing of Industrial grade alcohol? Does Presscane Ethanol, which the MBS Director general has agreed that it is non-food grade alcohol, contain 0% methanol as determined by the MBS Laboratory? Was the South African Laboratory wrong in detecting 0.014% methanol? Is the MBS Director General assuring the public that methanol is an accepted ingredient in hand sanitisers and has no any adverse effects on humans?” query Mlombe and Dzamalala.

“The Director General appears not to be aware of which research methods are used to answer which research questions and that research has phases. Fourthly, the Director General has never responded to our direct communication to the Bureau in spite of our several efforts to get the required information.

“When all these factros are considered, we find the above press release and its tone unprofessional and regrettable. The two of us work for Kamuzu University Of Health Sciences (KUHES) where our job descriptions include teaching, research and service provision. Recognising that some research may not have enough funding to afford University based research or may not be funded at all or may not be thematically relevant to our scope of practice but nevertheless be within our capabilities and of public importance, we joined up with other colleagues outside KUHES to establish Health and Civic Research Initiative; where we conduct some studies of public interest including the study referred to in the above press release. With this communication, we are attaching our report of the work we did. The report was sent to Pharmacy and Medicines Regulatory Authority (PMRA) because by the time we completed the work, we had been informed that the regulation of hand sanitisers in Malawi had been transferred from MBS to PMRA. But when emailing our report to PMRA, it was also copied to Malawi Bureau Of Standards, Ethanol Malawi, and Press Cane on 15^th November, 2020. Needless to say that PMRA acknowledged receiving our submission but we are yet to receive a response from PMRA on the submission.

“Of note is the fact that in the report, we struggled to find standards for ethanol content in Malawi hence we used external standards (USA, CANADA). However, at a later stage, we came across local Malawian standards for Ethanol. These have been attached towards the end of this communication and it is the same standard that the Director General has quoted in his press release,” reads the statement from Mlombe and Dzamalala.

They maintain their concern that public safety may well continue to be compromised until the issues we raised are addressed, adding that the press release from the Bureau did not provide any data to change our perception on the potential health hazards of the Press Cane Ethanol.

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