The pharmaceutical regulator has set up a specialised laboratory to keep tabs on the safety and quality of medicines already approved for sale in the country.
The Pharmacy and Poisons Board (PPB) has established a Sh300 million post-market surveillance lab to ensure medicines in the market are still as safe, efficacious and of quality as approved by the regulator. PPB’s Director of Quality Control Dr Obadiah Naikuni said the new lab is also able to test the quality of herbal medicines, cosmetics and food supplements.
Others are medical devices, tobacco products and radiation-emitting substances that are now regulated by the Board under its expanded mandate. “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 lab, which is based at PPB’s headquarters in Nairobi, will be conducting tests on both locally-manufactured and imported drugs and pharmaceutical products to determine if they are compliable with required standards.
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Dr Naikuni said the new lab will support the work of mini-labs and specialised handheld drug-testing gadgets already deployed by the board in parts of the country to monitor quality and performance of medicines.
The mini-labs are in areas where traffic of fake drugs is likely including Nairobi, Mombasa, Kakamega, Kisumu, Migori, Kericho, Kisii, Eldoret, Kajiado, Kwale and Busia.
Samples found to be suspect or non-compliant in the field using the mini labs will now be forwarded to the new lab for definitive testing and action taken.
Unlike the new lab, the mini labs do not have the capacity to test Herbal products, Medical devices, cosmetics, radiation emitting substances, tobacco products and food supplements.
“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.
The official said the lab will reduce 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. PPB conducts Post-market surveillance of medicines through regular random sampling and testing to ensure they are still safe and of required quality.
Those that fail the tests are recalled from the market. According to available data, producers of substandard medicines often target those for malaria, tuberculosis HIV/AIDS, for counterfeiting among others.