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Cutting corners to import fake drugs

By | April 11th 2012 at 00:00:00 GMT +0300

By DANN OKOTH

The provincial drugs inspector sits uncomfortably in his comfy office chair as thoughts flood his mind.

The torrid breeze sweeping through his window precipitated by the hot humid coastal weather caps a miserable afternoon for the expert with Pharmacy and Poisons Board (PPB).

That past week had seen the veteran pharmacist wrestle with difficult options as pressure piled on him to deal with a particularly suspicious drugs consignment that had docked at the Mombasa port the previous week.

What should have been a simple, even mundane, clearance exercise had slowly turned into a nightmare for the drugs inspection boss who was at the time working in Mombasa, after it emerged only five out of the 17 items in the container had been declared.

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"Moreover, 13 items in the container had not been registered in Kenya and could not be allowed into the country," recalls the officer who cannot be named because he fears possible reprisals.

"I promptly instructed my officers to detain the consignment for further investigation and possible confiscation and destruction," he says. But what would follow was a dramatic chain of events that bespeaks volumes about the country’s stuttering drugs import regulations and surveillance system characterised by institutional framework weaknesses, official lethargy, impunity and corruption that now puts millions of lives at risk.

Even as the inspector sweated over his next course of action, the direct line rang. "I’m the owner of the consignment you are holding. I’ve spoken to your boss and he has instructed me to collect my cargo," barked a man of Asian origin from the other end of the line.

"So if you still want your job release the container immediately," he went on. Flabbergasted, the officer says he called one of his bosses in Nairobi to report the threat he received.

"You deal with it," he recalls his boss answering rather curtly. "You know how things go, don’t you?"

"I was shell-shocked. But not only that, I was also afraid because I did not know what would follow," the officer says.

Delicate balance

Not that he had not heard or personally encountered corruption at the board. But never before had he faced a compromising situation where the top echelon of the PPB appeared to be deeply involved.

Just then, he says, a Mercedes limousine pulled up in front of his office at the Kilindini Harbour. Two burly men who appeared to be bodyguards of a prominent personality approached him and told him "their boss" wanted to see him.

"I reluctantly, but courageously got into the back seat of the car. I remember sitting next to an expensively clad Asian who was smoking a cigar.

"We drove around Mombasa for a while — nearly an hour. All along he never spoke a word to me. I figured this was calculated to scare and intimidate me," he recalls.

"When we finally came to a stop — at a particularly grimy and insidious part of the city, he ordered his minders to get out of the car. He then tossed a brown envelope onto my lap. There is Sh400,000 inside, share it with your boys. Nobody should get hurt. Nobody should get fired —there is no need for it. He told me and ordered me out of the car," he adds.

"I had no choice but to take the money. Either way I would be doomed considering what I had heard from my boss," the officer explains.

After a week, he says, one of his bosses called him to Nairobi where he was offered a further Sh600,000 after a thorough dressing down. He says he was also ordered to get smarter next time and keep situations under wraps faster when they emerge before they get out of hand. The officer says he continues in his job but with a guilty conscience.

Big tragedy

Indeed, his experience is just the little story off the bigger tragedy of failed drugs importation system and inspection and surveillance mechanisms and official corruption.

It now emerges that a well oiled syndicate involving pharmaceutical drugs inspectors, customs officials, the police and narcotic drug lords ensure that not only falsified pharmaceutical products find their way into the market, but the country is also flooded with narcotics.

On September 7, last year, Médecins Sans Frontières’ missions in Kenya detected quality problems with antiretroviral medicines (ARV) used to treat people with HIV. MSF nurses reported irregularities on the appearance of the product such as friability and discolouration of the tablets.

A week later the drugs were confirmed to be falsified versions of World Health Organisation (WHO) quality-assured drugs containing lamivudine (150mg), zidovudine (300 mg), and nevirapine (200 mg) — that were purchased in good faith via a supplier approved by the PPB.

WHO estimates that 30 per cent of drugs in Kenya are counterfeit with the loss to pharmaceutical industry to the tune of $130 million annually.

Import regulations

To understand how unregistered, expired, narcotics or even falsified drugs can find their way into the market we sought to find out about PPB’s import regulations.

While the process appears quite stringent and fool proof, involving meticulous profiling by PPB, clearance from Kenya Revenue Authority (KRA) and the watchful eye of the port police, many unscrupulous importers are still able to infiltrate the system.

The fact that there are a few sacred cows along the system makes effective profiling, monitoring and prosecuting offenders almost impossible.

The sacred cows come in the name of private hospitals, non governmental organisations and mission hospitals. These organisations get what is called Part One Poisons import permit, which is subjected to little or even no scrutiny at the port of entry.

While medical products under other certification are subjected to thorough scrutiny at the port, including stripping down to the last single item to verify their authenticity, holders of Part One Poisons Permit would simply walk through.

In the eyes of many industry insiders, the document is like a blank cheque, and one that has been abused by both genuine and unscrupulous drugs importers.

"Today if you got that certificate you would not want to return to your job of writing because you can bring anything into this country and nobody would ask you," the drugs inspector tells me.

While denying that PPB officials abet or are involved in corrupt deals, Deputy Registrar Dr Fred Siyoi explains that Part One Poisons Permit is issued under humanitarian considerations to NGOs and mission hospitals and sometimes to hospitals that need to urgently import certain drugs.

"The certificate is usually issued to NGOs and other organisations on humanitarian mission but under very strict conditions," says Siyoi.

"First we must profile the NGOs to ascertain they are registered in Kenya. Secondly, they must declare all that they are intending to import, which must be verified at the port of entry," he adds.

The problem is the PPB relies on Medical Officers of Health (MoH) from the various districts, who may not have the resources to carry out thorough scrutiny of the NGOs to provide them with this information.

On the other hand, NGOs often receive drugs donations for specific humanitarian purposes, which are not subjected to any verification at the point of entry and people have exploited this loophole to bring uncertified drugs into the country.


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