A source at Shalina Pharmaceuticals has exclusively told the Zambian Business Times – ZBT that the batches of Vitamin C tablets that has been recalled may have changed colour because of poor storage conditions.
The source who said they were not officially authorized to publicly speak on behalf of the company said there maybe someone behind this whole scandal [poor storage causing the change in color] and the company hopeful that all the facts will be out in the open soon.
The source said Shalina pharmaceuticals is currently not selling any Vitamin C tablets as it is waiting for the Zambia Medicines Regulatory Authority (ZAMRA) to advise on the way forward. He emphasized that Shalina Pharmaceuticals will not do anything that is against the regulatory authority or the country.
The Zambia Medicines Regulatory Authority (ZAMRA) advised the public not to buy Cevite tablets (Vitamin C) bearing batch numbers 0371572 and 0372251 which was imported into Zambia by Shalina Phatmaceuticals.
On January 22, 2021, Shalina Pharmaceuticals Zambia issued a recall citing some change of colour in some tablets to brown as the reason behind the action. Shalina Pharmaceuticals Zambia recalled the Cevite 500mg tablets even before ZAMRA issued its recall message.
In its motive of recall, Shalina pharma advised wholesalers, hospitals and retail pharmacies to instead exchange the defective batches with non defective one, but the statement did no say anything on any remedial actions that would be taken for those that had already consumed the vitamins from the recalled batches.
However, Pharmaceutical Expert Jerome Kanyika questioned the process of certification by the Zambia Medicine Regulatory Authority (ZAMRA) that medicine goes through before its put on the market for public consumption.
He told ZBT that there are some senior staff at ZAMRA that are in the forefront of covering up the mess on behalf of the Pharmaceutical companies who supply substandard drugs and medical utilities.
Kanyika said the recalling of medicines that has been happening lately is an indication that ZAMRA is not doing its job in ensuring that the quality and standard of medicine is certified before being circulated to the public.
Speaking in an exclusive interview with Zambian Business Times-ZBT, Kanyika said that it is normal to have a recall of medicines say, once every two years, and this should normally be initiated by the manufacturer themselves and not the regulator, so the current happenings are very alarming.
“Under normal circumstances, the rate of recalling medicines from circulation should not be as much as it has been lately, the way we are recalling drugs speaks volumes because within a short period of time, we have done it too many times. You cannot recall so many medicines in two years as has been the case since 2019”, he said.
Kanyika also mentioned that the World Health Organisation (WHO) does not certify some of these drugs that being imported into Zambia, adding that some of the Pharmaceutical companies in Zambia buy substandard medicines at very low prices.
“In Zambia, as long as you have written good English and put up a big profile about your company, then it will be certified and you will be given market authorisation”, he said.
Kanyika added that countries like Zimbabwe [despite all the current challenges] ensure that the regulatory body travels to inspect the pharmaceutical company that manufactures drugs before registering it on their market.
When asked how some medicines which are certified are ending up being recalled, he stated that “When registering a drug, some pharmaceutical companies buy medicine from a well-known pharmaceutical companies which they use to get the initial certification”.
“But what happens then is that they then source substandard and in some cases counterfeit drugs which are then brought in and distributed. This is why you are seeing all these recalls. So, when the regulator goes and inspects the drugs being supplied, that when these gaps are found”, he said.
“The other problem is that some of these Pharma companies go for cheap products instead of buying quality and authentic products, they go for substandard products without considering the consequences of such actions because they are cheaper and they make more profits”, he said.
There is also need for the public to be more cautious, “Provided someone is selling it at a cheaper price, we don’t question ourselves to say why is this medicine selling at a lower price than this one, we don’t even check to see if a pharmaceutical company is certified by WHO or not”, he lamented.
