Pharmaceuticals regulator defends itself against quality breaches


The state regulator of the multi-billion shillings pharmaceutical sector has defended itself against claims that it has allowed a local manufacturer of medicines to continue operation even without meeting quality standards.

The Pharmacy and Poisons Board has issued a statement saying it allowed Mac’s pharmaceuticals to continue operation since all its essential drugs including painkillers, anti-malaria drugs and anti-bacterials are of good quality, safe and efficacious for consumption in line with required standards.

The firm, based in Nairobi’s industrial area manufactures at least 80 medicines including the common painkiller “Maxadol”, antacid tablet “Tumbocid” and cough tablets “Cofrid”.

The claims, circulated in media platforms, had suggested that Mac’s Pharmaceuticals was found to be in breach of Good Manufacturing Practices (GMP) for medicines in July last year but PPB has not yet suspended its license despite being informed.

This was allegedly after inspection carried out by the National Quality Control Laboratory, an agency under the PPB whose mandate is testing of medicines on behalf of the PPB to confirm if they meet quality standards before the regulator issues or renews licenses of firms manufacturing or importing them.

MAC’s was allegedly found to have been using water whose quality did not meet GMP  standards in the manufacturing of drugs but has been allowed to operate for almost a year by PPB thereby compromising health of Kenyans with questionable medicines.

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But certificates of analysis of medicines produced by the firm issued on various dates between November last year and April this year and seen by the Standard indicate that painkiller “maxadol”, antifungal medicine Nystatin oral drops and antimicrobial “maxicort cream” were found to be compliant with required standards set by PPB.

“We wish to assure the public that there should be no cause for alarm. The products by the Mac’s Pharmaceuticals have the compliance certificates,” said the statement from PPB.

PPB’s intervention comes as a welcome reprieve for the reputation and operations of the local pharmaceutical firm that faced the damaging claims. It may help calm jitters among Kenyans who regularly consume its products.

Mac’s Pharmaceuticals, which was founded in 1977, manufactures medicines for the local and regional market. Its products are registered in Kenya, Uganda, Malawi, Tanzania, Rwanda and Ethiopia.

“We are in compliance with GMP where all processes are defined and documented, equipment validated and all manufacturing activities supervised by qualified personnel,” the firm  describes itself in its website.

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