The Zambia Medicines Regulatory Authority (ZAMRA) has taken swift action to protect public health by recalling 87 different types of medicines and substances manufactured by Leben Laboratories Private Limited, based in India. The recalled products include injections, tablets, cough syrups, capsules, and ointments, among others.
The decision to recall these medicines came after ZAMRA raised concerns about the quality, safety, and efficacy of products from Leben Laboratories. As a result, ZAMRA has suspended the marketing authorizations for all medicines manufactured by Leben Laboratories for a period of five years.
Makomani Siyanga, the Director General of ZAMRA, expressed grave concerns about the potential risks posed by the Leben Laboratories products currently on the market. In a statement to ZNBC News, he emphasized that the quality and safety of these medicines cannot be guaranteed, and they may pose a significant health hazard to the public.
As a result of the suspension, ZAMRA has made it clear that no product manufactured by Leben Laboratories Private Limited will be allowed in the country during the five-year period. They have called upon all health facilities, pharmaceutical outlets, and members of the public to immediately cease the distribution, dispensing, or use of any product manufactured by Leben.
What pre-importation tests were done? Will the money paid be refunded? When were the medicines imported? Not a very helpful report and leaves this reader wondering if ZAMRA is up to the task.
Regulation isn’t about fault finding but prevention. People have already been exposed and so this isn’t good work. When it comes to sensitive products such as medicine, compliance to production processes and quality assurance require to be monitored. For imported goods there’s chance that there maybe omissions because only a few are sampled. Zambia has the capacity to manufacture almost all the medicines that we need the drawback lies with GRZ which is the largest consumer of medical products. The attitude of the current Minister doesn’t help matters so such occurrences are likely to increase under her tenure. Those of us that are exposed have seen some facilities in which some goods that we import and have realized that it’s better to even buy locally or to produce our own
This company has been on our market for years. Have we identified any adverse events associated with these medicines. Most of their products were more affordable and even trusted by patients and doctors. To ban them for 5 years… Are we trying to wipe out competition?