MAC’S Pharmaceuticals was last year found in breach of approved World Health Organisation (WHO) standards following an inspection and publication of a report that recommended its immediate closure.
But the manufacturer has continued to operate nearly one year after it failed the July 12, 2017 inspection, exposing Kenyans to the risk of consuming substandard medicines.
The company manufactures a range of generic drugs, including anti-malarials, antibiotics, antihistamines, dewormers, injections and painkillers such as maxadol.
The Pharmacy and Poisons Board (PPB) is once again on the spot after a Nairobi pharmaceutical company that produces essential drugs for treatment of malaria and bacterial infections was found operating nearly one year after it failed a quality inspection test.
MAC’S Pharmaceuticals was last year found in breach of approved World Health Organisation (WHO) standards following an inspection and publication of a report that recommended its immediate closure.
But the manufacturer has continued to operate nearly one year after it failed the July 12, 2016 inspection, exposing Kenyans to the risk of consuming substandard medicines.
MAC’s Pharmaceuticals manufactures a range of generic drugs, including anti-malarials, antibiotics, antihistamines, dewormers, injections and painkillers such as maxadol.
The National Quality Control Laboratory (NQCL) is the agency that inspects drug samples and drug manufacturing premises before the PPB issues them with operating licences.
NQCL said in its inspection report that it had found MAC’S Pharmaceuticals non-compliant with WHO standards and recommended that its licence be immediately suspended.
“MAC’S Pharmaceuticals in Industrial Area, Nairobi was found non-compliant with approved WHO current GMP standards for dosage forms categories and activities thereto,” NQCL director Hezekiah Chepkwony said in a letter to the firm.
“Consequently, the manufacturing activities and premises manufacturing licences issued by the PPB for the year 2017 stand suspended, having been issued without consideration of GMP (good manufacturing practice) status. You are obliged to comply for public safety.”
The inspection report says MAC’s was found to have been using water whose quality did not meet “a certain WHO grade” in the manufacturing of drugs.
The notice dated April 27 was also copied to the PPB, the Director of Medical Services, Jackson Kioko, who is the board chairman, the Health secretary and the Health principal secretary. None of them admitted to having seen the report.
The PPB acting registrar, Fred Siyoi, whose agency is in charge of enforcing standards in the pharmaceutical industry, did respond to phone and text messages on the matter.
Health secretary Cleopa Mailu said he had not seen the report but promised to respond to the queries after speaking to Dr Chepkwony.
Dr Kioko said he was not aware of the information and asked that the matter be further investigated.
He, however, promised legal action should investigations find the manufacturer had run afoul of any industry regulations.
“We could close, deregister the firm and take them to court,” Dr Kioko said.
The PPB Act gives the NQCL director powers to inspect premises and inform issuing of certificates of compliance by the PPB.
The NQCL also has the power to enter and sample any medicinal substance under production in any manufacturing premises to certify that the method approved by the board is being followed.
MAC’S Pharmaceuticals general manager Morris Ogutu said the company could only close if the industry regulator, the PPB, withdraws its licence.
“We are not closed. We are still operating legally,” said Dr Ogutu.
“The source of information is misleading and such information can only be passed to us through the PPB, who is the regulator.”
Dr Ogutu added that “if they (PPB) were to close us officially they can execute that order by any means.”
The High Court in March issued an order prohibiting and restraining the PPB from usurping the lab agency’s functions of inspecting premises and issuing certificates of compliance to GMP.
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