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PMRA Recalls Diabetes Drug

PMRA Recalls Diabetes Drug

The Pharmacy and Medicines Regulatory Authority-PMRA has made a recall order of Actrapid Soluble Insulin, a drug used to treat diabetes from its stakeholders and patients, following a discovery that some unscrupulous people are changing labels for unknown reasons.

PMRA spokesperson Joseph Josiah says a couple of weeks ago, they received a complaint through a monitoring mechanism, that unknown people were concealing information on the drug, which he says is a huge concern to authorities.

He says the authority acknowledges this will have an adverse effect on patients, thus while tirelessly working with the manufacturer, Novo Nordisk of France, to identify what is exactly happening, it is also recalling three batches of the drug.

“The recall involves May 2020 manufacturing date, and October 2022 expiry date batches, three in total, and we have so far sent samples to the manufacturer in the ongoing investigation to establish whether the drug is the original that was ordered. That does not necessarily mean that all these batches are affected though, it’s just a precautionary measure,” said Josiah.

He adds, “We are dealing with the lives of people. A lot of people receive this medicine, as you know insulin is administered for diabetes, so we cannot manage to have these patients at risk. What we have done therefore is to immediately advise all the hospitals to quarantine the medicine, including asking patients to immediately stop using and return them.”

A health expert Professor Maureen Chirwa has bemoaned the tendency of unscrupulous people who for whatever reasons, steal or make disturbances on drugs in the country.

“This is very unfortunate for whatever reasons they are altering that for because it is something to do with human life. We do not know at this point what will happen to patients that will consume these medicine,” said Professor Chirwa.

She is further worried that not all patients, especially in rural areas may hear the message, therefore appealing to all health officials to assist in spreading the message, as well as guarding against this tendency which puts at risk human life.

Under the laws of Malawi, distributing or selling expired drugs, and tampering with or falsifying labels are serious offenses that attract a 10 million kwacha fine, or 10-year imprisonment upon conviction.

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Last modified on Tuesday, 24/05/2022

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