As drug regulators fight, rogue importers, makers cash in

A fight between regulatory agencies under the Ministry of Health for control of the lucrative business of making and importing pharmaceuticals is being blamed for the proliferation of substandard and counterfeit medicines on the market, exposing Kenyans to health risks and even death.

So fierce has been the rivalry between the National Quality Control Laboratory (NQCL) and the Pharmacy and Poisons Board (PPB) that at one point outgoing Health Cabinet Secretary Sicily Kariuki intervened and transferred the NQCL directors from the institution and disbanded the board.

But the intrigues did not end there. Indeed, several cases went to the courts, with the transferred officers seeking a reversal of Ms Kariuki’s decision. The court battle exposed the crisis in the crucial sector, with sources saying cartels have jumped in to force consignments of medicines that have failed the quality test onto the market.

The importing companies, one of which is associated with the family of a vocal member of Parliament, are said to give fat bribes to rogue officers in the Health ministry to circumvent the World Health Organisation standards for human medicines, medical devices and veterinary medicines.

Some drug manufacturers, for instance, lack the right measures to ensure digoxin, a drug for treating blood pressure, has the standard 0.5-milligram potency, instead producing five-milligram tablets. An overdose could kill a patient instantly upon ingestion, warn experts.

“If the 0.5 milligrams were supposed to reduce blood pressure from 200 to 120, the 5-milligram tablet, being 10 times stronger, could lower the pressure to 20, which kills a person instantly,” said a senior pharmacist at NQCL.

A tablet, he said, is composed of two parts: medicine, which should form 10 per cent or even five per cent, and a carrier composed of starch. Starch anchors the medicine, which is mostly too small to produce on its own. But some companies have been packaging just the starch.

“A patient would think they are treating their condition whereas the “medicine” is just as good as eating ugali,” said the pharmacist.

The lab claims that the companies get away with manufacturing or importing injectable drugs that are not sterilised (to kill bacteria). Such medicines, when injected into the bloodstream, take bacteria directly to the heart and brain, and can easily snuff out a person’s life.

But every day Kenyans walk into chemists and unknowingly buy such drugs, as they are not equipped to tell fake ones except through a lab test.

NQCL came into being in 1992 to complement PPB in testing and registering drugs as well as licensing manufacturers. While the roles of the two agencies should be complementary, they have been working at cross purposes, leading to supremacy wars.

The bone of contention has been the role of inspecting pharmaceutical companies before issuing GMP (Good Manufacturing Practice) clearance.

The ministry, which is supposed to call them to order, has been accused of siding with the PPB, and the lab managers feel that their role in public safety has been whittled down.

Last year, Ms Kariuki ordered the removal of the director, Dr Hezekiah Chepkwony, and his two deputies, Dr Pius Wanjala and Dr George Wanganga, and sacked the NQCL board. The falling-out ended up in the courts and the suits were concluded on November 15, 2019 for the board and January 31, 2020 for the directors. A Nairobi court reinstated the contesting parties, terming their removal illegal.

Employment and Labour Relations Judge Onesmus Makau ruled that “the petitioners maintain their current service and positions at the NQCL without loss of benefits and status until any intended deployment is done in compliance with the Constitution, statute law and the human resource policies and procedures manual for the Public Service in force”.

The Pharmacy and Poisons Act vests the mandate to issue GMP in NQCL, which also analyses medical samples for the issuing of certificates of analysis.

“NQCL is a facility of examination and testing of drugs and any material or substance from or with which and the manner in which drugs may be manufactured, processed or treated and ensuring the quality control of drugs and medicinal substances with a view to determining whether such drugs or medicinal substances comply with this Act or rules made thereunder,” reads Section 35D of Chapter 244.

The mandate of PPB, on the other hand, is built on that of the lab such that upon ensuring that a company has a valid certificate of analysis and GMP, they can go ahead to issue them with registration of the drugs and subsequent import and export permits. They also register drugs.

The lab’s board claims that PPB has not been acting on their quality recommendations, instead carrying out parallel tests and even allowing some uncertified companies to continue producing drugs.

“PPB registers drugs that are not certified and which have failed analytical tests and GMP. That is how substandard drugs flood our markets,” said one board member.

PPB CEO Dr Fred Siyoi told the Saturday Nation they were appealing the recent court decision.

“Read the (Pharmacy and Poisons) Act and the Health Amendment Act of 2019. I wouldn’t want to comment because they’re a subject of interpretation by the (appellate) court,” he said.

While acknowledging that there was bad blood between PPB and NQCL staff, he insisted that their differences    have not affected their operations or led to the sale of fake and substandard medicines.

“The two institutions are doing whatever is expected of them. We have a problem with people (at NQCL), but not the institution. There exist personal differences,” he said.

He denied allegations that they were taking bribes to clear certain companies that don’t meet the criteria to operate.

NQCL director Dr Chepkwony has cited Mac’s Pharmaceutical Ltd and Sphinx Pharmaceutical Ltd as companies operating despite failing a quality inspection.

“Mac’s Pharmaceuticals in Industrial Area, Nairobi, was found non-compliant with approved WHO current GMP standards for dosage forms categories and activities thereto,” Dr 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 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, 2017 was also copied to PPB Director of Medical Services Jackson Kioko, who is the board chairman, and the CS and PS.

Ideally, errant companies should be closed down and only reopen after another inspection to ensure that they have complied with standards and given a clean bill of health.

Mac’s Pharmaceuticals’ General Manager Morris Ogutu said that PPB licensed the company to operate and that they could only close if the regulator withdrew its licence.

“We are not closed. We are still operating legally,” Dr Ogutu was quoted as saying. “The source of information is misleading and such information can only be passed to us through the PPB.”

The producer of essential drugs for treatment of malaria and bacterial infections is still operating.

The Saturday Nation called the office of the director of Sphinx Pharmaceutical, Lilian Bonareri Abuga, and a staff promised to call back “once the director is in”. By press time, they had not returned our calls.

Yesterday, a man who identified himself as John Githi, an importer of pharmaceuticals with Nahope Company Ltd, said he was concerned about the coverage of the pharmaceutical sector and especially the operations of the PPB.

“I am made to understand that you’re writing a story about importation of drugs. We want to know what you want to air; my colleagues too are concerned. We have a right to know because it’s a public matter,” he said.

He said that importers have a problem with NQCL and described PPB as a “performing agency”.

“We have a big issue with the national lab. It is useless. They never give you anything of quality,” he said.

Asked whether they had raised the concerns with the lab, he said they planned to do so.

“PPB is good, they believe in quality,” he said.

The parliamentary Committee on Health, aware of the squabbles between the agencies, gave them time to negotiate. More than a year later, there is no respite.

“We are aware of it and some recommendations on the PPB Act were done,” said committee chair Sabina Chege. “We didn’t agree on many things, that is why we asked the parties to consult more. We have power games going on, which is not fair. They should think about the quality and safety of our drugs first, not power play.”

According to PPB statistics, 70 per cent of medicines are imported while 30 per cent are locally manufactured. Of the locally manufactured drugs, 60 per cent are exported, mostly to the East African Community.

Last year, WHO sent out a warning that fake broad-spectrum antibiotic drug Augmentin was circulating in Kenya and Uganda. The national lab requested PPB to submit the suspect samples for analysis and Dr Siyoi only told the media then that “we are aware of the WHO warning” and promised to act on it.

The Kenya Association of Pharmaceutical Industry (Kapi) has also expressed fears that the proliferation of counterfeit and unregulated medical drugs and equipment will be counterproductive to the attainment of accessible health for all, one of the Big Four agenda pillars. Kapi chairperson Dr Anastasia Nyalita, while marking the World Anti-Counterfeiting Day in 2019, reiterated the association’s petition to the poisons board, to enhance its market surveillance activities, and fully utilise digital technologies to track shipments and identify grey and counterfeit products at ports of entry to ensure that all products available in the Kenyan market are regulated.

“At Kapi, we are concerned that such counterfeit and unregulated products have continued to enjoy easy market access notwithstanding their detrimental impact on the national healthcare standards,” she said.

A study by pharmaceutical applied researchers from the University of Nairobi’s School of Pharmacy showed an eight per cent prevalence of unregulated or grey medicinal brands, but the quality lab workers say the figure could be understated.

Back in 2009, the PPB board held a special meeting to discuss unregistered, counterfeit drugs from China held at the Mombasa port. The puzzle was that the consignment marked “GoK, Not For Sale” and estimated to cost Sh9 million were brought in by Dawa Ltd, a manufacturer based in Ruaraka, Nairobi, which had been awarded a tender by the Kenya Medical Supplies Authority (Kemsa) to supply their own drugs. They also found that the import permit issued in 2008 was altered to read 2009.

“The drugs are labelled as manufactured by Dawa Limited in Kenya, yet they are from China and are therefore counterfeits,” the then board chairman Dr F. M Kimani said in a letter to the Industrialisation ministry. 

The drugs were manufactured by Yanzhous Xier Kangtai Co.

The Health ministry has been accused of turning a blind eye to dubious manufacturers and importers and making skewed appointments to the board.

CS Kariuki’s office did not respond to our emailed queries.

A Machakos court quashed one such appointment after a petition filed by one Wambua Maithya questioned the board’s introduction of qualifications criteria not captured in the law.

“That the applicant must have served for at least five years in senior management or leadership position at the PPB board or similar organisation is contrary to the Pharmacy and Poisons Act. The law also does not limit the applicants to being a pharmacist,” the petitioner told the court.

High Court Judge George Odunga agreed, ruling that “the advertisement for the position of the registrar/CO of PPB was unlawful and unconstitutional.

“It was contended that the requirements stipulated therein were not provided for and were in fact meant to favour the acting registrar to the detriment of other potential applicants,” Justice Odunga said.

There have also been attempts to abolish NQCL. The 2018 Health Law (Amendment) Bill introduced by the Health ministry flopped.

Earlier in April 2017, Parliament transferred the function of GMP to PPB by amending the Pharmacy and Poisons Act, but the move was quashed by the courts in January 2018.

When the Health Law (Amendment) Bill was eventually passed in 2019, there were allegations that two sections had been sneaked in, touching on the functions of NQCL. The law stated that they would henceforth share the role of conducting GMP in factories and inspection.

The duplication of roles by two government agencies brought confusion, with conflicting reports. Cartels took advantage of the confusion to sell fake drugs.

The NQCL board went to court in May 2019, seeking stay orders in the implementation of the law on the grounds that its amendment was passed unconstitutionally. The court granted the orders, terming the action “obnoxious”.

It is after this that Dr Chepkwony and Dr Wanjala were moved. Before that the lab and PPB boards met at Ms Kairuki’s office and there was no agreement on the differences. Sources at the meeting say the NQCL were non-committal.

Dr Chepkwony was sent to Mathari Hospital as a pharmacist while Dr Wanjala was sent to Kenya Health Professionals Oversight Authority. Dr George Wanganga was deployed to the National Public Health Laboratories.

Dr Charles Kandie was appointed director and Dr Josephat Mbuva as his deputy.

The trio filed a petition in the Employment and Labour Relations Court, (124 of 2019), seeking to stop their transfer on the grounds that it was in contravention of fundamental rights and freedoms.

“The transfer failed to observe national values and principles as well as public service thereby injuring our feelings and dignity, exposing us to public ridicule and odium and possible prejudice as regards future national service in view of the requirement of Chapter 6 of the Constitution and occasioning us losses and damages,” read the petition.

The ministry, in its response, sought the petition to be struck out, arguing that it lacked merit.

“The petitioners are civil servants in the ministry, bound by Constitution, Employment Act and the Public Service Regulations, and especially the prerogative of the employer to deploy and transfer them anywhere in the republic of Kenya,” argued the respondents, the minister, the PS and the Attorney-General. The directors obtained conservatory orders pending determination of the case.

On July 1, the board was fired and a new one hired in the same gazette notice.

The board members went to court (petition 137 of 2019) and obtained orders suspending the changes until November 15, 2019, when it was reinstated.

On January 31, 2020, the directors’ case was also concluded in their favour.

 They were awarded Sh500,000 as compensatory/ disturbance damages for the violation of their rights to fair administrative actions by the respondents.

Although they were reinstated, there exist frosty relations that the lab says have seen it lose Sh100 million in budgetary allocations.

Dr Chepkwony says the agency’s operations have been paralysed.