Pharmaceuticals regulator rejects suspension of drugs manufacturer

The state regulator of the pharmaceutical sector has turned down calls for suspension of the operations of a local manufacturer of medicines for allegedly failing to meet required standards.

The Pharmacy and Poisons Board (PPB) has rejected a report by the National Quality Control Laboratory (NQCL), an agency under it, to suspend the operating licence of Nairobi-based Mac’s pharmaceuticals terming it contradictory to other recent documents issued by the lab.

The firm, based in Industrial area, manufactures a line of 80 medicines for the local and export market, including the common painkiller “Maxadol”, antacid tablet “Tumbocid” and cough tablets “Cofrid”.  It has been in operation since 1977 and its products are registered in Kenya, Uganda, Malawi, Tanzania, Rwanda and Ethiopia.

PPB has issued a statement saying it allowed Mac’s pharmaceuticals to continue operations since all its essential drugs including painkillers, antimalarials and antibacterials are of good quality, safe and efficacious for consumption in line with required standards citing NQCL’s own documents.

“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.

Certificates of laboratory analysis of medicines issued by NQCL itself on various dates between November last year and April this year gave medicines manufactured by Mac’s pharmaceuticals a clean bill of health, contradicting the alleged inspection report by the same agency.

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The approved medicines included painkiller “maxadol”, antifungal medicine Nystatin oral drops and antimicrobial “maxicort cream” among others.

The approval dates in the certificates are after the alleged NQCL’s inspection in July last year in which Mac’s was accused of failing to meet the Good Manufacturing Practice (GMP) standards.

The certificates, seen by the Standard, have raised questions about the operations of NQCL in discharging its mandate of testing medicines at the request of PPB to confirm if they meet quality standards.

The contents of NQCL’s report, cited in media platforms, suggested that Mac’s manufacturing operations failed to meet manufacturing standards for quality and safe medicines. PPB was accused of failing to act on the report to suspend operations of the firm, a claim PPB has rejected.

This followed an NQCL inspection that allegedly found the manufacturer to have been using water whose quality did not meet required standards. NQCL blamed PPB for not acting on its recommendation.

 Under the law, PPB issues licenses to pharmaceutical manufacturers or importers after submitting drugs samples for testing at NQCL, which is an agency under 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.

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

Its products are packaged in form of tablets, ointments/creams, syrups, tablets, capsules and injections. 

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