To keep tabs on the safety and quality of medicines already approved for sale in the country the pharmaceutical regulator has set up a specialized laboratory.
The Pharmacy and Poisons Board (PPB) has established a Sh300 million post-market surveillance lab to make sure medicines in the market are still as safe, efficacious and of quality as approved by the regulator.
Dr Obadiah Naikuni PPB’s Director of Quality Control said the new lab is very much capable of testing the quality of herbal medicines, cosmetics and food supplements.
“The new lab has enhanced the board’s capacity to combat substandard medicines, monitor treatment failures, drug resistance, adverse drug reactions among other crucial regulatory matters,” he said.
The Nairobi based lab, will be conducting tests on both imported drugs and locally-manufactured and pharmaceutical products to determine if they have complied with required standards.
Monitor quality Dr Naikuni said the new lab will support the work of mini-labs and specialized handheld drug-testing gadgets already deployed by the board in parts of the country to monitor quality and performance of medicines.
If samples are found by the mini labs to be non compliant with the required standards they will then be forwarded to the new lab for definitive testing and then necessary action will taken.
The mini labs do not have the capacity to test Herbal products, Medical devices, cosmetics, radiation emitting substances, tobacco products and food supplements but the new labs will be capable of testing all of the above.
“For PPB to fully exercise its mandate, it had therefore to establish a laboratory which will be able to do post-market surveillance of all products under its regulatory mandate,” said Dr Naikuni. He also said that the lab will minimize costs and time for post-market surveillance of pharmaceutical products.
He said the Board has already recruited specialised personnel to run the laboratory and are undergoing further training. To ensure they are still safe and of required quality, PPB conducts Post-market surveillance of medicines through regular random sampling and testing. Those that fail the tests are taken off the market.