Pharmaceutical Society of Zambia (PSZ) president Jerome Kanyika has asked the Zambia Medicines Regulatory Authority (ZAMRA) to punish Emcure Pharmaceuticals Limited of India for supplying substandard HIV/AIDS drugs.
Last week, ZAMRA issued a public notice to all healthcare professionals and the general public on the recall of eight HIV/AIDS drugs from the market.
“Zambia Medicines Regulatory Authority wishes to notify all healthcare professionals and the general public that Emcure Pharmaceuticals Limited, India, has initiated a voluntary Drug Product Recall for the under listed eight batches of ATAVOR-R (Atazanavir 300mg and Ritonavir 100mg) tablets that were supplied to the Zambian market. The recall has been necessitated by stability studies that indicated that the product will only be within specifications up to the 24-month time-point (i.e. February, 2020) but may not comply at the 36-month time-point (February, 2021). This recall is a precautionary measure and members of the public who might have the affected batches are advised to CONTINUE taking the medicine until it is substituted by their healthcare provider,” ZAMRA director general Bernice Mwale stated.
Mwale listed the recalled drugs as follows: Product details: ATAVOR – R Tablets (Atazanavir 300mg and Ritonavir 100mg tablets) S/N Batch No. expiry quantity per pack (i) EM83043 Feb 2021 30 Tablets; (ii) EM83044 Feb 2021 30 tablets; (iii) EM83045 Feb 2021 30 tablets (iv) EM83047 Feb 2021 30 tablets; (v) EM83049 Feb 2021 30 tablets; (vi) EM83051 Feb 2021 30 tablets; (vii) EM83062 Feb 2021 30 tablets; and (viii) EM83064 Feb 2021 30 tablets.
However, in an interview, Kanyika expressed worry on how many more unfit drugs were still on the Zambian market and being consumed.
“This, again, goes to what we have been calling for to say can we please have a directorate for pharmaceutical services. We are tired of this! Sometimes, you find that people who are in the forefront of ordering these drugs know nothing about the drugs, but now, what we are seeing is each and every day, they are recalling drugs. Are the people of Zambia now protected in terms of consuming these drugs? How many of these drugs are we consuming that are not okay, but are on the Zambian market? Take the health of the people seriously. It is very sad and we are now getting worried as Pharmaceutical Society of Zambia,” Kanyika said.
He called for stiff punishment on the erring pharmaceutical company.
“We also appreciate the efforts ZAMRA is putting. At least we can say that ZAMRA now is not tolerating any nonsense in terms of the drugs. They are up to the task and they are doing it. And with the coming up of a new laboratory, which they are building along the new Airport Road, we expect more and more drugs to be tested so that Zambians are protected. But the current scenario is very worrying! We need to make sure that we put some punitive measures against that company that supplied the drugs, which are not up to standard. How did we allow this drug to be on the Zambian market? This calls for what we have been saying that it is because professionals are not involved from the first step. Stability test of drugs should be done before the drug is supplied on the market,” Kanyika urged.
“Those drugs that have been recalled by ZAMRA are ARVs, and the ARVs are precious drugs that are funded by the donor community. The issue is people have been taking these medicines for some time and this is when they are saying voluntary recall. And then in the same statement from ZAMRA, it is saying ‘because of the stability test.’ But we cannot have a big pharmaceutical company to recall a drug and say ‘it is because of stability test.’ No, let ZAMRA say the truth. In as much as the people of Zambia can be sure that ZAMRA has now woken up and started checking these drugs, they need to go a step further because these drugs are on the Zambian market. Let them be testing for stability tests on all the drugs for other contamination that can be there unlike subject the people of Zambia to these drugs and then after that we recall them.”
He appealed to ZAMRA to ensure that all drugs entering the country were thoroughly screened before being cleared for public consumption.
“As Pharmaceutical Society of Zambia, we are asking ZAMRA to make sure that, if possible, they test all the drugs that are on the Zambian market because how many drugs have been recalled within a short period of three months? And there are more drugs that have been on the market. And these drugs have been supplied in government institutions. So, what is going to happen to the supplier? Is the supplier going to [get back] the drugs and how much money has been lost due to the recall of these drugs? Is the supplier also going to replace the medicine or not?” asked Kanyika.