SOME foreign material has been discovered in a bottle of Co-Trimoxazole in Mwinilunga district, North-Western Province.

The foreign materials, which were found in a bottle of Cotrikant Suspension, were identified as a battery and a spring.

But ZAMRA says after thorough checks, the rest of the bottles at the reporting facility did not contain foreign material.

In a letter dated December 31, 2021 addressed to the Ministry of Health Permanent Secretary for Technical Services, Zambia Medicines Regulatory Authority (ZAMRA) acting director Makomani Siyanga said the Authority received the report on December 24, last year.

He stated that the Authority could not rule out the possibility of the foreign materials having been placed inside the bottle when the medicine was in the custody of the end user.

“Sir, we wish to inform you that on 24th December, 2021, the Authority received a report of a suspected medicine quality problem on Cotrikant (Paediatric Co-Trimoxazole Oral Suspension BP 240m9/5ml) batch No. P820091 from Mwinilunga District Health Office. The report stated that foreign materials, namely a spring and a battery, were found in a bottle of Cotrikant Suspension. The product is manufactured by S Kant Health Ltd, India, supplied by Missionpharma Zambia Limited and distributed by the Zambia Medicines, and Medical Supplies Agency (ZAMMSA),” stated Siyanga.

“The Authority conducted an investigation to ascertain whether or not there was adequate evidence to suggest that the product was adulterated with foreign materials at the time of dispensing. However, this could not be established because the person who submitted the report to the health facility had opened the bottle prior to returning it to the health facility. Therefore, we had no way of verifying at which point the product was adulterated. The rest of the bottles at the reporting facility did not contain foreign material. We could not rule out the possibility of the foreign materials to have been placed inside the bottle when the medicine was in the custody of the end user.”

And in an interview, Pharmaceutical expert Jerome Kanyika said the incident showed that ZAMRA did not do its job thoroughly.

“The letter that I saw said that ZAMRA cannot ascertain a product or that foreign substances were found in the bottle or if they were not found in the bottle, that is where the tricky part is. I wish ZAMRA would have also checked the quality of the product that has been put in terms of the batch numbers. When such foreign substances are found or allegedly found in a product, you need to check exactly if the quality of the medicine is up to date. I think that is the best that should be done. ZAMRA was supposed to check the quality, when a foreign substance is found in a product that is a quality issue. They were supposed to check all others and test. Unfortunately, you know that 85 percent of the products that we consume in Zambia are substandard and that clearly indicates [that] ZAMRA which is supposed to make sure that the products are checked accordingly are not doing their work,” he said.

Kanyika, therefore, urged ZAMRA and the Zambia Medicines and Medical Supplies Agency (ZAMMSA) to ensure that the lives of citizens were protected.

“Imagine for a product to pass through ZAMMSA and also it has to pass through ZAMRA [before] it comes to the members of the public, meaning that the system itself is doing nothing. It is very much porous. That needs to be looked into and these two institutions should work to make sure that they put the members of the public first as compared to any other business which they do. Their role is simple, it is to protect the Zambian people, but the Zambians feel not protected by the drugs they are consuming. These two institutions are proving to be very much irrelevant in the eyes of the members of the public. As a regulator, we need to have standards. When you are registering medication we need to make sure that whoever is bringing the drug, they need to show that they have purified the product. It is very unfortunate, when you go to a foreign country they start talking about your country to say we are having fake drugs coming through Zambia,” said Kanyika.