3 months ago
5
A year after British pharmaceutical giant, GlaxoSmithKline exited Nigeria and asthmatic patients who depended on its inhalers faced significant distress due to the medication’s scarcity, investigations showed that fake and unregistered inhalers have flooded Nigerian markets. JANET OGUNDEPO reports
For a 28-year-old marketer, Rose Daniel, having to deal with the side effects of an anti-asthmatic tablet, was an experience she never wanted to have anymore.
Every time she took the medicines, uncontrollable tremors sent shivers down her spine, making her lead a less productive life.
But succour came when her consultant, eight years ago, prescribed an asthma preventer, Seretide Diskus inhaler, with zero side effects.
However, following the exit of GSK last year, and the scarcity of the inhalers, the fear of a return to the daily tremors gripped Daniel’s mind.
Determined to spare no cost, the Cross River indigene reached out to notable pharmacies across the country and eventually bought three packs to last her for many months, pending when normalcy would return and the drugs become available.
Once the inhalers became available, Daniel told PUNCH Healthwsie, that she ensured she got her inhalers at a registered pharmacy she was sure sold genuine and approved drugs.
But one day, while at work, she saw the pack of a Seretide inhaler with a colleague and wondered why the pack looked different from hers.
After a quick perusal of the pack, the truth hit her in the face.
“It had no NAFDAC (National Agency for Food and Drug Administration and Control) Registration Number!” she said.
Daniel said she was grateful that she had ensured she had only bought her inhalers and other drugs from a trusted pharmacy store.
On a journey to discovery
Following a tip-off from an asthmatic patient that fake and unregistered inhalers, Seretide inhalers, had flooded the market, PUNCH Healthwise embarked on a fact-finding mission to pharmacies and the drug market in Church Street, Idumota, Lagos State.
Entering into Church Street, the popular hub for wholesale and retail medicines, the tearing sounds of semitransparent adhesive tape (cellotapes) filled the atmosphere.
Human load carriers bore several cartons of purchased medicines and hospital consumables on their back to deliver them to their respective buyers.
After a brief observation of the market nuances, this correspondent inquired at some shops about where to get Seretide Diskus. Then, the referrals began.
A tall, dark-complexioned middle-aged man enthusiastically greeted another man and boldly said in the Yoruba language, “We’ve been in this market since the 1980s.”
This man would later become a guide as he led this correspondent to the prescription shops where the inhaler could be bought.
“If I take you to the place where the other woman described, the price there is expensive, I’ll take you to this shop,” the guide responded.
Unfortunately, the woman at the shop did not sell such a product, leading to another round of referrals.
At last, a young man garbed in native attire, called Nosa, was recommended.
This correspondent then showed him a picture of an unregistered Seretide inhaler, with the pack content written in English and Urdu, a language mostly spoken in Pakistan and India.
After a perusal of the picture, Nosa responded in the affirmative and led us to his ‘second shop’.
Nosa, this correspondent would later learn, sells wholesale and retail prescription medicines.
Curious as to why his name rang through like an anthem on the lips of other sellers, this correspondent asked whether he was the main distributor of Seretide Diskus.
“I am not the only one, I sell prescription medicines,” Nosa opined, as he led us through the noisy market to another shop.
Once we got there, he asked his ‘brother’, Lucky, if the inhaler was available and he responded in the affirmative.
This correspondent was offered a seat on the bench placed by the narrow entrance to the shop to await the return of the salesperson assigned to ‘bring’ the inhaler from an undisclosed location.
Undoubtedly, the unregistered medicines were not to be displayed on the shelves. Only a specific request from a ready-to-pay buyer was the criterion for the inhalers to be brought out.
After about 30 minutes of waiting accompanied by several pleas to be patient, the Seretide Diskus arrived wrapped in a medium-sized black nylon bag.
After checking the content of the bag to be sure “what I ordered was what I got,” this correspondent discovered that the name of the drug was written in Urdu language unlike the one presented.
Throwing further questions at Lucky, he responded, “Every batch comes with a new package but it is from the same producer as the one you showed me. This batch came in English. The one in Urdu was produced last year.”
However, an analysis of the packet showed that it was manufactured by “Glaxo Wellcome Production, France and the Batch Releasing Site: Glaxo Wellcome United Kingdom Limited, Brentford, Middlesex, UK and imported by Modern Pharma Trading Company.”
While the production and expiry dates read January 2024 and January 2026, respectively, the glaring absence of the National Agency for Food and Drug Administration and Control Registration Number rang the alarm bell.
What makes them fake?
In this context, a counterfeit and fake drug is defined by NAFDAC as any drug or drug product which is not registered by the Agency by the provisions of the Food, Drugs and Related Products.
Furthermore, the NAFDAC Drug and Related Product Labelling Regulations, 2019, prohibits the manufacture, import, export, distribution, advertisement and display for sale or use of any drug or drug product that is not labelled by the regulation.
It further reads, “The outer and inner labels of a drug shall clearly show the registration number of the Agency (NAFDAC REG. NO.) assigned to it as indicated on the Certificate of Registration in a manner prescribed by the Agency.”
Any conviction of contravention of the Regulations prescribes the guilty individual to one-year imprisonment or a fine of N50,000 or both and the corporate body to a fine of N100,000.
Providing further insights, the former president of the Pharmaceutical Society of Nigeria, Olumide Akintayo, stated that having fake drugs was a serious offence that violated sections 1.1 and 2.1 of the Fake Drug Acts.
Aside from the violation of the law, Akintayo explained that the influx of fake drugs portends a high incidence of morbidity and mortality rates.
He further discouraged the sale and handling of unregistered drugs and food substances and urged government agencies that have oversight responsibilities to move into action to stem the tide of fake drugs.
The battle for ‘breath’
PUNCH Healthwise had in November 2023, reported the travails of asthmatics, who after GSK’s exit, could no longer find the inhalers.
For those who found them, the astronomical price increase was a burden too heavy to bear, as some of them resorted to using little dosages of the medications for them to last longer, while others bought other brands with cheaper prices.
Lifelong treatment
Although asthma is not curable, inhaled medication, oral and injectable medications can control asthma symptoms, allowing people with asthma to lead normal, productive and active lives.
This made asthmatics use their preventive inhalers daily and go about with the reliever inhalers.
According to the World Health Organisation, asthma is a major non-communicable disease affecting both children and adults but is the most common chronic disease among children.
Asthma symptoms are caused by the inflammation and narrowing of the small airways in the lungs, which can lead to a combination of cough, wheezing, shortness of breath and chest tightness.
As of 2019, the Nigerian Thoracic Society stated that 15 million people were asthmatics. This implies that 15 million out of the over 213 million Nigerians, have asthma.
Many asthmatics use Seretide
The president of the Nigerian Thoracic Society, Professor Musa Babashani, confirmed to PUNCH Healthwise that although alternative controller inhalers were available, many asthmatics in Nigeria rely on Seretide.
With over 13 million Nigerians living with asthma, the NTS president warned that the influx of fake controller inhalers would make it even more difficult for patients to manage their symptoms, potentially leading to higher morbidity and mortality rates.
Rising uncontrolled asthma cases
Babashani further disclosed, “The prevalence of patients with uncontrolled asthma is increasing. Since the exit of GSK and the escalating exchange rate of the naira versus the dollar, affordability has been greatly reduced by most of our patients and even access to some of these registered drugs has fallen. At the end of the day, the number of asthmatics who have access to qualitative controller inhalers has reduced.
“So, in clinical settings, we have observed an increase in the number of asthmatics who have their asthma uncontrolled, largely because of lack of access and decreased affordability to this important set of drugs.”
He also asserted that using fake or substandard drugs to treat any clinical condition results in wasted time and resources for patients, poorly controlled diagnoses, higher hospitalisation rates and an increased risk of death from the disease.
The NTS president called for increased surveillance by drug regulatory agencies and professional bodies like the Pharmaceutical Council of Nigeria, to ensure that sales points are prevented from selling substandard, unregistered or fake drugs and inhalers.
He urged the government to strengthen the implementation of importation waivers for medical consumables and drugs and called on regulatory agencies to confiscate unregistered medicines while punishing those selling them.
Babashani also advocated increased awareness among users and prescribers about the growing influx of fake inhalers, emphasising the need to educate them on how to distinguish between counterfeit and genuine inhalers.
Cut in the web
To further investigate the extent to which the unregistered inhalers have flooded the pharmaceutical shops, our correspondent visited some local and popular dispensing pharmacies.
PUNCH Healthwise found out that most local dispensing drug stores do not sell asthmatic inhalers.
However, some recognised drug stores, sold the unregistered Seretide Diskus inhaler for N28,000.
The pack, at first glance, looks closely like the registered Seretide Diskus, but the back of the pack has directions for use written in Indonesian.
Moreso, this inhaler lacked the NAFDAC REG number, yet it was displayed on the shelves of the pharmacy stores.
Unarguably, the displayed Reg. No. (DKI1991500167B1) differed from NAFDAC’s six-digit authentication number.
Further details on the pack are: “Manufactured by: Glaxo Wellcome Production, Evreux, France. Imported by PT Glaxo Wellcome Indonesia. ©2021 GSK group of companies or its licensor.”
More findings
While still on Church Street, our correspondent sampled several prescription stores for the unregistered Seretide inhaler.
PUNCH Healthwise discovered that while some of them were cautious to respond to the request of persons seeking unregistered products, others were bold enough to recommend the alternatives.
For example, an attendant at Alpha Rising Store, popularly referred to as Obiora’s shop, initially insisted that the unregistered inhaler was not available but on further interactions, he admitted to having the unregistered one but demanded that our correspondent must be ready to buy it as it would be brought from the ‘other shop.’
“That one is N20,000 while the registered one is N28,000,” he eventually said.
Like Lucky, the attendant at Obiora’s shop affirmed that the one with the Urdu language was produced last year. Affirming that the unregistered inhaler he was about to sell was produced in January 2024.
This correspondent behaved unconvinced and left the shop.
Varying prices
Inquiries from several shops on Church Street revealed varying prices of both the registered and unregistered Seretide inhalers.
At Obiora’s shop, the registered inhaler sold for N28,000 but at another store, Mostan Global, the wholesale price was N19,000 while the retail price was N22,000.
However, at Obiora’s shop, PUNCH Healthwise gathered that unregistered inhalers were imported from Turkey.
While Obiora’s attendant sold the unregistered one for N20,000, Mostan agreed to sell it for N18,000.
On the first visit to the market, this correspondent ended up with two unregistered products.
A day after, this correspondent returned to Church Street and specifically asked for the registered Seretide inhaler which was eventually bought at N19,000, the wholesale price.
It has the NAFDAC REG No: 04-3323.
Further findings
Undoubtedly, the unregistered inhalers were not displayed on the shelves and the attendants followed the same mode of operation as Lucky, who would send another attendant to an undisclosed location and bring the inhaler wrapped in black nylon.
PUNCH Healthwise also discovered that the registered Seretide sold in pharmacies within communities cost between N30,000 to N70,000.
Merchants of death exploiting scarcity
Speaking further on the issue, the past PSN president stated that the enactment of policies that promoted scarcity was responsible for the influx of unregistered medicines in the country.
He described the scarcity as one induced by the high costs of genuine medicines, stating that “merchant of deaths” exploited such gaps to flood the markets with cheaper, parallel and unregistered alternatives.
Akintayo stated that although the exit of GSK opened up opportunities for local manufacturing of genuine and generic equivalents of some branded products, the excessive tariffs charged by NAFDAC were the major reason for the high and escalating cost of drugs.
He called on the National Assembly to immediately amend the current Fake Drug Act which provides for the federal and state drug tax forces in the 36 states of the Federation and FCT Abuja, to promote maximum collaboration between the Pharmacy Council of Nigeria and NAFDAC.
Akintola stated that this synergy would lead to the closure of obnoxious open drug markets in Nigeria which are currently operational in the 36 state capitals.
The pharmacist advocated the reduction of high tariffs by government agencies, more funding of these drug regulation agencies and the need to come up with legislative action.
He proposed stiffer punishments for persons found in possession of fake drugs.
Nation’s health unguarded
A Consultant Pharmacist and the Managing Director and Chief Executive Officer of Merit Healthcare Limited, Lolu Ojo, stated that the rising prevalence of unregistered medicines increased the probability of using the wrong, substandard and fake drug.
He stated that NAFDAC’s intervention was to ensure that the available in circulation was the right drug.
“That’s why they have that slogan, ‘Safeguarding the nation’s health’ because once it is in circulation, somebody will use it. Somebody desperate will certainly see a drug called Seretide without necessarily knowing which one is right or wrong and just get them used like that,” the pharmacist said.
He stated that although the sellers of unregistered drugs were aware of their actions, their thought of making a valuable and cheaper alternative for the patients was wrong.
“It is very wrong to use the one that has not been certified because it is not only in Nigeria that fake drugs are sold. Fake drugs are sold in other parts of the world and when you bring them here and people are buying them, the implications to health are heavy. A lot of people can die,” he said.
The PSN fellow highlighted that curbing the influx of unregistered products needed the involvement of all stakeholders.
The consultant pharmacist urged persons treating life-long conditions, like asthma to ensure they have a genuine source where they get their medications.
Ojo advised NAFDAC to engage in more surveillance to ensure that unregistered drugs are not in circulation.
He urged the government to fix the economy, asserting that everyone in charge of the nation’s commonwealth should stop stealing.
Porous border fuelling fake drugs
The National Chairman of the Association of Community Pharmacists, Ambrose Ezeh, pinned the influx of unregistered drugs on the porosity of the Nigerian borders.
During an analysis of the three Seretide inhalers bought by PUNCH Healthwise, the ACPN National Chair noted that only one of them had the NAFDAC REG Number and certified it, “Good one.”
He, however, noted that it was the responsibility of NAFDAC to determine the originality of the number on the pack.
Poor asthma control
“The implications of fake drugs in asthma control are massive,” a pulmonologist at the University of Nigeria, Nsukka, Enugu State, Professor Cajetan Onyedum said.
He added that since the exit of GSK, many asthmatics had reverted to ineffective medications and inadvertently got fake asthmatic drugs.
The researcher on Lung Infections and Asthma stressed the need for regulatory agencies to tighten control over the influx of medications into the country.
Patients shouldn’t use unregistered products – NAFDAC
In a response on Saturday morning, NAFDAC’s Director General, Professor Mojisola Adeyeye, asserted that patients are not allowed to use unregistered products.
She said, “They must confirm authorisation by NAFDAC and the surrounding circumstances for use.”
Adeyeye further said, “No drug product should be on sale without NAFDAC authorisation. There are three types of authorisation in NAFDAC. One, registration; two, service drug scheme: the drug is not registered in Nigeria but may be needed to treat a special case, a practitioner or the representative of the patient may apply to NAFDAC to source for it outside the country and a permit will be granted. Three, laboratory or Clinical Trial Samples.
“These products may be smuggled into the country by travellers or from neighbouring countries. Since they are smuggled in, may be conveyed through a compromised condition of storage or transport thus, the quality is compromised and not in its best potency, efficacy, or safety. Such products are often mopped up by officers on surveillance whenever found.”
PUNCH Healthwise further presented evidence of the fake inhalers, the amount, where it was bought and the details in the inhaler packs.
The DG confirmed that the Seretide inhaler whose description for use was written in the Indonesian language was not a NAFDAC licensed drug.
“Is this a NAFDAC-licensed drug? No,” she responded.
The NAFDAC boss emphasised that the agency carried out routine surveillance to mop up unregistered products, stating that the fight against counterfeits was everyone’s responsibility.
Adeyeye also stated that the agency will intensify surveillance at the entry points, selling points and facilities.
“We may not see all, that is why consumers/stakeholders like you can draw our attention to what you meet or see, NAFDAC alone cannot do it, the fight against counterfeits is everybody’s responsibility, we all (stakeholders) should work together to fight spoilers of our communities.
“NAFDAC will intensify surveillance at the entry points, outlets and facilities, selling points. sensitises the public, and prepares public alerts on any product found for public interest,” she said.
The agency listed the registered Seretide products as, “Seretide 125mcg/25mcg. Fluticasone propionate/Salmeterol Xinafoate NRN: 04-6850 MAH GSK, Nigeria. Manufacturer Glaxo Wellcome Production, France.
“Seretide 50mcg/250mcg Diskus Inhaler Powder NRN: 04-3323. Manufacturer: GlaxoSmithkline LLC USA.
“Seretide Diskus 50/500mcg Inhalation powder NRN: B4-9735 Manufacturer GlaxoSmithkline LLC, India.
“Seretide Evohaler 125/25mcg NRN: 04-6850.”
English (US) ·