A silent but vicious war over the regulation and approval of medicine imports worth billions of shillings is unfolding at the Ministry of Health.
The National Quality Control Laboratory (NQCL) and the Pharmacy and Poisons Board (PPB) are locked in a supremacy battle that has sucked in Afya House, Parliament and two Cabinet Secretaries.
At stake is the safety of the drugs brought in from China, India and Bangladesh as fears of public health being sacrificed for private good continue to swell. Over the years, the two complementary institutions have been tearing down each other in courts and in the fields.
PPB is responsible for the regulation of the practice of pharmacy and trade in pharmaceuticals while NQCL is its technical arm, ensuring actual quality control through testing of medicines and inspection of premises. If NQCL says a drug is not safe, then PPB has no option but to stop its use.
But when Parliament earlier this year moved in to settle the mess between them, it left more confusion when it amended the Pharmacy and Poisons Act to give PPB the powers to perform the NQCL functions without amending NQCL mandate.
In the wake of Parliament’s move and President Uhuru Kenyatta’s assent, the two institutions were left with similar mandates, and set loose on both pharmaceutical players and innocent Kenyans.
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“It’s total confusion and with it the risk of unregistered, counterfeited or substandard drugs and medicine flowing into the country. Whenever NQCL closes down a manufacturer, PPB clears them, and vice versa,” a source aware of the goings-on told the Sunday Standard.
By June this year there were close to 10 court cases between the two institutions whose synergy is required to catch counterfeit drugs.
These include NQCL’s move for judicial review application No 168 of 2019 in which it challenged Parliament’s move to amend the law and duplicate its roles.
And the star in these cases is one Dr Pius Wanjala, a senior deputy director at NQCL who doubles up as the institution’s lawyer.
Wanjala has won virtually all the cases, including one on Friday where the Attorney General and the Health Ministry wanted to stop him from representing the institution.
“I have the mandate to represent the NQCL. I am not litigious. I just like to get things done correctly and the courts have always bailed me out,” he says.
In May 2017, according to letters in our possession, the two institutions were squabbling over the licence of two wealthy local pharmaceutical manufacturers over alleged non-compliance with the World Health Organization’s Good Manufacturing Practices.
In the midst of the squabbles, the manufacturers continued to operate despite the concerns.
On June 13, Health CS Sicily Kariuki held a mediation meeting between NQCL and PPB in which the ministry rallied the former to withdraw the court case challenging the constitutionality of the changes of the law.
“The unwavering wish is that the ministry has a strong PPB and a fully functional NQCL performing distinct but complementary functions with adequate room for cooperation and coordination between the two institutions,” a document from the meeting says.
Although NQCL had agreed to withdraw the matter, the counsel for the Senate, which had been enjoined in the case supporting NQCL, dithered in supporting the withdrawal, leading to a brief stalemate.
And on June 24, the ministry swooped in on NQCL, transferring its CEO and director Dr Hezekiah Chepkwony, and his two deputies, Dr Wanjala and Dr George Wanganga (deputy director finance and administration).
Through Dr Wanjala, they moved to court arguing that the CS had usurped the powers of the NQCL’s board of management. The NQCL board, which incidentally is appointed by the board of PPB was not in existence at the time of the transfers.
A board that had been appointed by PPB Chair Dr Jackson Kioko was yet to start acting after the five members of the old board moved to the Employment and Labour Relations Court to challenge the appointments.
Heard and deterermined
The court in effect suspended both the new and old boards. In the new Petition No 124 of 2019, before the Employment and Labour Relations Court by the transferred officials of NQCL, Justice Onesmus Makau gave conservatory orders stopping the transfers until the case is heard and determined.
Dr Charles Kandie, the man appointed by the CS to take over, was instead consigned to a small office on the first floor at the PPB headquarters along Lenana Road.
The current battleground is the new directive on compliance with Pre-Export Verification of Conformity to Standards. Dr Kamamia Murichu, the chair of Kenya Pharmaceutical Distributors Association, who has in the past fought NQCL, argues it is occasioning shortage of drugs and pushing up prices.
He says the directive is flawed in all senses and is simply not workable since all tests will have to be done at NQCL, “an organisation that simply does not work.”
The new order requires that all drugs coming into the country be tested for efficacy before being allowed into the market.