NAFDAC Re-opens Julius Berger Pharmacies Nationwide (May 19, 2006)

National Agency for Food and Drug Administrative and Control (NAFDAC) has re-opened all Julius Berger Pharmacies recently shut down for importing and dispensing fake and unregistered drugs and other unwholesome practices.

This re-opening was as a result of full implementation of compliance directive issued to them by NAFDAC such as payment of fine and subsequent letter of apology.  Director-General of NAFDAC, Prof. Dora Akunyili who gave the order for re-opening the pharmacies said the Agency’s enforcement action was a re-affirmation of its resolve to deal severely with any individual or corporate organization engaged in unwholesome practices injurious to health of Nigerians without consideration for the social status or influence of the offender.  Prof. Akunyili maintained that the construction giant has shown remorse after learning some hard lessons and consequently vowed not to indulge in such unethical practices in future.

NAFDAC Regulatory Officers have already evacuated all the fake and unregistered drugs found in those pharmacies for destruction.  They have according employed a qualified Pharmacists and stopped discriminating between Nigerians and expatriates in dispensing drugs to its patients.  The Director-General reiterated NAFDAC’s determination to reduce the level of fake drugs in the country to a single digit before the end of this year.

It would be recalled that 3 weeks ago, the Julius Berger Pharmacies were closed down in connection with the sale of fake drugs which were imported from Sinochem Ningbo, a Chinese company blacklisted by NAFDAC.Beside, the company was also involved in the discriminatory and unethical practice of dispensing fake/substandard drugs to Nigerians and reserving quality ones for expatriates.

BBC's Documentary "Bad Medicine" Wins Prestigious Pulitzer Prize For Television (May 15, 2006)

A British Broadcasting Corporation (BBC) Documentary show-casing the relentless battle being waged against fake drugs in Nigeria by Prof. Dora Akunyili’s led National Agency for Food and Drug and Administration and Control (NAFDAC) has won the prestigious Pulitzer Prize for television.

The Award-winning Documentary titled “Bad Medicine” was produced by Veteran Reporter, Olenka Frenkiel and aired on the BBC, widely viewed by millions of its global audience.  Mr. Frenkiel is set to pick up the coveted prize which is also known as PEABODY AWARD at a colorful ceremony featuring the cream of the world media on 5th June, 2006 in New York, USA.

The star documentary captures how Prof. Dora Akunyili transformed NAFDAC from a near moribund Agency into a formidable fighting force against fake drug Barons and their criminal activities. It also presented the winning strategies adopted by Prof. Akunyili, the attendant challenges and hazards faced by the ebullient Director-General of NAFDAC who has put her life on the firing line in the fight against counterfeit medicines.

“Bad Medicines”, the award –winning BBC documentary is a moving story of how fake drugs endangered the lives of million of Nigerians and wreaked havoc on the country’s healthcare delivery system.

Mr. Frenkiel’s choice of NAFDAC’s fake drug war under professor Akunyili has been described as a masterstroke since the subject herself had won over 230 nation and international awards in recognition of her fight against drug faking and counterfeiting.

The Documentary has also been aired by Nigerian Television Authority (NTA), African Independent Television (AIT), Channels and Silver bird Television stations.

NAFDAC Shuts Down Julius Berger Pharmacies Nationwide (April 27, 2006)

The National Agency for Food and Drug Administration and Control (NAFDAC) has finally wielded the big stick shutting down all Julius Berger Pharmacies nation-wide.

The closure of the pharmacies situated within the precinct of Julius Berger Clinics in Abuja, Port Harcourt, Warri, Abgor, Bauchi and Calabar was prompted by NAFDAC’s recent investigation which uncovered a check-list of fake and unregistered drugs stocked by the Germen Construction Giant.

Deputy Director Technical Services, Alhaji Hashim Ubale Yusufu who led the enforcement operation told Journalists that the closure of the pharmacies in all Julius Berger Clinic across the country was aimed at safeguarding the health of unsuspecting innocent Nigerians by preventing them from taking fake and substandard drugs.

Alhaji Yusuf explained that the closure of the clinics was a normal regulatory procedure undertaken by the Agency to put the pharmaceutical outlets of the company on the right track.

He warned that NAFDAC will not condone Julius Berger’s Discriminatory practices whereby substandard drugs were dispensed to Nigerians and quality drugs reserved for German expatriates.

According to him, the Agency decided to close only the pharmacies rather than the entire clinics nation-wide in order not to cause undue hardship to the patients who were receiving treatments.

The Deputy Director regretted that despite the over whelming positive impact of NAFDAC’s public enlightenment campaign on the need for all drugs imported and distributed in the country to be registered, Julius Berger disregarded the policy and continued to dispense unregistered drugs to patients who are non-Germans.

Alhaji Yusuf also stated that another offence committed by the company was the discovery of sixteen different brands of fake drugs imported from Sinochem Ningbo, a Chinese Pharmaceutical Company already blacked by the Agency.

The drugs imported from the blacklisted company by Berger included the following:

• Fruscmide injection

• Cotrimoxazole Powder for Oral Suspension

• Ferrous Sulphate Tablets

• Vitamin B-Complex Injection

• Chloramphenicol Eye drops (0.5%)

• Amoxicillin Capsules

• Ampicillin Sodium Injection

• 0.5% Metronidazole Injection

• Diclofanac Sodium Injection

• Promethazine HCI Injection

• Aminophylline Injection

• Teracycline Eye Ointment

• Ibuprofen Tablets

• Hydorcotisone Acetate

• Promethazine Hydrochloride Tabs

• Diclofenac 1% gel

• Hyoscine hydrobromide Injection

Alhaji Yusuf disclosed that in addition to those substandard drugs, some Dipyrone injections earlier banned by NAFDAC because of their severe adverse reactions were found in Julius Berger Pharmacies.

He reiterated NAFDAC’s determination to deal decisively with any regulatory violation that endangers public health irrespective of the social standing and status of the culprit.

Another Giant Stride as NAFDAC Commissions N350million Laboratory (April 2006)

Pronouncement on the quality and efficacy of drugs, processed food, packaged water and other regulated products is one of the most strategic and significant statutory functions of the National Agency for Food and Drug Administration and Control (NAFDAC). This important mandate is not carried out in abstraction but predicated on a corpus of scientific knowledge, analytical efficiency and dexterity and possession of state of the art Laboratory equipment.

When NAFDAC pronounces on the quality of drugs and other regulated products it is regarded as the final seal of authority and guarantee of safety and wholesomeness of the product. Such pronouncements are often with mathematical exactitude and clinical precision such that the results of products analysis cannot be questioned or faulted. NAFDAC’s pronouncement on quality of product has the force of law.

It is in recognition of this onerous responsibility that the Agency has made concerted efforts to be ahead of the industry which it superintends and regulates both in terms of scientific knowledge, equipment and the wherewithal. A Regulatory Agency without a functional and well equipped Laboratory is like a medical Doctor without a stethoscope or a surveyor without map and cartographical equipment.

The mood was therefore ostensibly upbeat and electrifying when NAFDAC recently commissioned its Ultra Modern Laboratory Complex at Borikiri area of Port Harcourt, Rivers State. The Director-General of NAFDAC, Prof. Dora Akunyili was in her eloquent best and she summed up the feelings and joy of dignitaries, stakeholders and staff gathered for the commissioning ceremony.

“We all know that Port Harcourt is an important gateway into the country through the sea and airports, therefore the need for a Laboratory situated here to take care of products from the ports and other areas of the South-South cannot be overemphasized. We thank God that at last we have completed the refurbishing of the building and equipping of the Laboratory with state-of-the-art analytical equipment. It is therefore a great joy for us to be here to get it commissioned”. The highly elated NAFDAC Boss gave an insight into how the Governor of Rivers State, Dr. Peter Odili eagerly donated a building for the construction of the Laboratory without any bureaucratic encumbrances and delay. She acknowledged the contributions of some dedicated and hard working staff of NAFDAC in making the Laboratory project a reality. The Professor of Pharmacology commended the Governor for his magnanimity and thanked him for being in the forefront of NAFDAC’s fight against fake drugs.

The commissioning ceremony provided another opportunity for the Governor to talk some little politics and he was vintage Sir Peter Odili. He spoke on his philosophy of governance and the cardinal principle of providing what is good for people without any prompting. The Governor paid glowing tribute to the NAFDAC Director-General in the following ways.

Going by the feelers from manufacturers, importers and Distributors of drugs, processed food, packaged water and other NAFDAC Regulated products from South-South Zone, the new Port Harcourt Laboratory has ended the untold hardship faced by stakeholders and bureaucratic delays experienced in getting their products registered. The practice before now was for producers/Importers of regulated products from South-South axis to send their products to NAFDAC Laboratory in Lagos for analysis and testing. The delay can best be imagined than described. It was therefore expected that these stakeholders were overwhelmed with joy when Governor Odili cut the tape to herald the commencement of Laboratory work in Port Harcourt on 31st March, 2006.

The Acting Director of NAFDAC Laboratory services, Mr. Okechukwu Ogbonna who was beside himself with joy showered encomiums on the Governor for his kind gesture and unalloyed support for NAFDAC. He narrated how sheer determination, abiding commitment and strong political will of Prof. Akunyili translated the Laboratory project valued at over N350million into a reality.

Mr. Ogbonna described the new Laboratory as “an architectural beauty and one of the most equipped in Africa”. He noted that the monetary value of some of the equipment ranged from N10m to N15m, while pointing out that the new Port Harcourt Laboratory has two latest functional High Performance Liquid Chromatography (HPLC) when some African countries can boast of only one HPLC. He elaborated further “considering the fact that NAFDAC has other functional Laboratories in Yaba and Oshodi (Lagos), Maiduguri and Kaduna, one can imagine how many HPLCS NAFDAC has in its kitty”.

On the trickle down effect of the Laboratory the, NAFDAC Director-General said “the war declared by the Federal Government on fake/counterfeit drugs, unwholesome food and other substandard regulated products has taken a giant leap today as we commission a fully equipped modern analytical Laboratory here in Port Harcourt, Rivers State. The Laboratory will help to further enhance the protection of the citizens of Niger Delta in Port Harcourt”.

Just as the stakeholders and NAFDAC staff in Port Harcourt savours and celebrate the new Laboratory, the Agency has stepped up efforts to complete another one in Calabar, Cross River State.

NAFDAC warns against fake vegetable oil - The Nigerian Guardian (August 2005)

THE National Agency for Food and Drugs Administration and Control (NAFDAC) warned consumers yesterday of the presence of adulterated vegetable oil in circulation. Known as Convey, the fake oil was described in a statement by the NAFDAC Head of Public Relations Unit, Abubakar Jimoh, as very similar to Envoy vegetable oil which is registered under NAFDAC.The statement disclosed that bent on removing all traces of the offensive oil from the market, NAFDAC Regulatory Officers from the Federal Capital Territory, Abuja stormed several markets in the city last week and evacuated hundreds of jerry cans of the product.

The Chief Regulatory Officer of NAFDAC, Abuja Office, Mrs. Akudo Amaeshi, who led the five-member team, said three major distributors of the fake vegetable oil had been arrested while frantic efforts were being made to track down the real kingpin behind the business.Amaeshi revealed that the three distributors apprehended by the agency were Messrs Hillary Uche, Isilege Marcellus and Okey Nwaogbu, who had already paid some fines as administrative penalty for the offence.

The Chief Regulatory Officer stated that other NAFDAC state offices had been directed to carry out raids in various markets within their domains in order to mop up the substandard oil from other markets nationwide.In a related development, the NAFDAC FCT, Abuja office, also arrested 10 illegal producers of unregistered and poor quality packaged water following a surveillance exercise carried out in several sections of the city.Amaeshi stated that the culprits were mainly women and civil servants, adding that the substandard sachet water impounded by the Agency were immediately destroyed to prevent further sales to the unsuspecting public.

She said the offenders had also been made to pay administrative fines to serve as deterrent to other illegal producers of sachet water.She advised consumers to be extra-vigilant, stick to identified registered brands of sachet water and to report suspected offenders to the nearest NAFDAC office.

Bad Medicine - Broadcast on Tuesday, 12 July, 2005 on BBC Two.

The counterfeit drug industry is huge and the profits are vast. Some are harmless but others are lethal. It could be described as the perfect crime. Fake drugs kill vulnerable people: the weak, the old, and the sick. And once consumed, the evidence is destroyed.

In 2003, four children died after undergoing cardiac surgery in a top teaching hospital in Nigeria.The adrenalin drips they had been fed with contained fake drugs."Fake drugs are murder" says Dr Dora Akunyili, the dynamic regulator of Nigeria's Food and Drug Agency (Nafdac).When Dora took the job at Nafdac in 2001, more than half of all drugs in Nigeria were counterfeits or substandard.Some contained just chalk or flour. Others, only a fraction of the active ingredient, triggering drug resistant strains of malaria, tuberculosis and HIV: the world's biggest killers.

"Eradication of counterfeit drugs should be treated as an international health emergency programme," Dr. Akunyili declares.In the UK, counterfeits have been found in high street chemists, and a fake Diazepam and Viagra factory was recently discovered in North London.All over the US, fake botox, heart disease and cancer drugs have found their way into hospitals and pharmacies; their death toll unknown.

Fake drugs could be in a pharmacy near you.

International effort

Imperfect holograms on packets can indicate that drugs are fake But the problem of fake drugs is not confined to Nigeria, or even the developing world. In the UK in November 2004, Allan Valentine was imprisoned for manufacturing fake Diazepam and Viagra in his Wembley warehouse where Indian tablet presses and chemicals were found.

In the US, where patented drugs are the most expensive in the world, fakes have penetrated the pharmaceutical chain from drug manufacturers, through wholesalers, to high street pharmacies. The American Food and Drugs Administration prosecutions have tripled in the last year. At a conference in Paris about counterfeit medicines, Dora demands concerted global action. "Eradication of counterfeit drugs should be treated as an international health emergency," she says.

She believes that raising public awareness has produced dramatic results in Nigeria and urges other nations to be more open. Unsurprisingly, drug companies around the world are fearful that their brand will be shunned if news of a fake gets out. But no matter how tough the situation gets for pharmaceutical industry, Dora will not be leaving any stone unturned.

Devastating

Late last year Nigeria's drug safety agency started getting reports that some patients had suffered unexpected fevers after surgery. So the agency collected samples of all the brands of water-for-injection they could find in Nigeria, and tested them.

The results were devastating. Of 149 samples, 147 were found to be contaminated; only two brands - one Swiss and the other from the United Arab Emirates - passed the tests and were certified safe for use. If they challenge us, we will disgrace them in court

Dr Dora Akunyili
"I was in shock. I needed pills to sleep, it was so frightening," the agency's director told the BBC.

Dr Dora Akunyili said the problem was that if she announced the results of the tests, she would cause panic; she couldn't withdraw the unsatisfactory brands from the market until enough safe supplies were available. It was only after the two authorized manufacturers had rushed in replacement supplies that the agency could put out its public warning.Nigeria does not manufacture water-for-injection locally; all the brands tested were imported, so the problem is unlikely to be confined to one country alone. Dr Akunyili said she was confident she could face down any legal challenge from manufacturers or importers.

"We have the samples - If they challenge us, we will disgrace them in court," she said.

Fighting Fake Drugs - Using honest women and fiery courage, a Nigerian pharmacist is taking on one of Africa’s worst ills: endemic corruption.

June 2 - She injected her insulin as usual and it killed her. Vivian Edemobi, a graduate student, died of hyperglycemia at age 23 in 1987 from a spurious drug—the vial was a worthless fake. And hers was far from an isolated case. At the time, well over half of the pharmaceutical drugs offered on the huge Nigerian market were counterfeit. Uncounted thousands of people died every year after taking medicine that contained useless or harmful ingredients. But this death was special in one way. The victim's sister, British-educated pharmacist Dora Akunyili, lectured at one of Nigeria's leading medical schools. To her, this was an especially excruciating violation of a public trust.

Akunyili now is winning a holy war against the killers in a crusade that speaks to one of Africa’s worst ills: endemic corruption. It’s a problem long-recognized by Western authorities. When Paul Wolfowitz took up his new post as head of the World Bank this week, he announced plans to lead an immediate mission to Africa. "Corruption is the biggest threat to democracy since communism," he warned. But it is homegrown activists like Akunyili who, by revolutionizing a moribund drug-regulation agency, is forging a paradigm for how deeply corrupt societies such as Nigeria’s can begin to turn around. Her success as leader of the National Agency for Food and Drug Administration and Control (NAFDAC) also bodes well for a national anti-corruption drive that this year has begun reeling in official after official—the centerpiece of President Olusegun Obasanjo’s final two years in office. Akunyili is a profile in personal courage. Arsonists torched her agency’s offices and labs, and she herself narrowly survived three assassination attempts. Yet she fights on, leaving her fate to God. At the same time, her appointment to her post says volumes about her president’s sincerity. An outsider to NAFDAC, she normally would have stood no chance of being named its director-general in 2000. But an anecdote about her filtered up to Obasanjo from her home in the eastern hinterlands. A government-run development fund she served sent her to London in 1999 to undergo an expensive operation. There, she learned the surgery wasn't needed, and asked the hospital to return a Nigerian government check for $20,000. "Aren't you a Nigerian?" a hospital staffer asked her—and proposed to keep a percentage and give her the rest in cash. Instead, she took all the money back to Nigeria and returned it. Not long afterward, Obasanjo personally phoned to summon her to the capital.

Akunyili turned first to her own staff of 3,000 pharmacists, technicians and enforcement officers scattered around the nation of 130 million people. Those who weren't totally demoralized were using their regulatory authority to extort bribes. "We were prisoners," said Ijeoma Chinaka, 41, a chief regulatory officer. Agents would seize whole containers of fake drugs only to see the drugs put back on the market after a VIP intervened on behalf of the importer. Akunyili weeded out incorrigible grafters and began to offer the rest incentives—foreign training, modern lab equipment, respect. Most stayed on. "When the leadership is dynamic, positive, the people can't help but shape up," says Okechukwu Ogbonna, deputy director of NAFDAC's testing labs in Kaduna. After the arsonists set them on fire last year, temporary quarters were established to house state-of-the-art testing gear. The attacks and nearly 100 public incinerations of seized drugs helped the vibrant Nigerian press spread word of the danger—and to encourage consumers to blow the whistle on wrongdoers.

After drug importers failed to bribe or intimidate Akunyili, kingpins in the drug trade allegedly tried to take her out. Her closest call came in December 2003, as she drove in a four-car convoy to her home village in eastern Nigeria. Six gunmen opened fire; a bullet pierced her headscarf and grazed her scalp. Police arrested—then allegedly executed—five of the attackers. The sixth spent a year on the run before turning himself in to federal authorities. He implicated Chief Francis Okoye, chairman of an association of medicine dealers who run the huge Onitsha open-air drug market in the east, and another leading dealer. Acting on his testimony, authorities arrested both businessmen. They deny the charges. "God indeed saved my life," Akunyili testified at a preliminary hearing in the case. A devout Roman Catholic, she says her proudest moment came when she learned that Pope John Paul II had offered prayers on her behalf.