Cairo, November 2014, (Al-Sabah) – Alaa, 28, lies on his sickbed at Nasser Institute Hospital as tears roll down his elderly mother’s face and his father holds his breath watching his son’s fight against death. Alaa’s father begs the doctor to take his or his wife’s kidney to ensure their son’s survival. Dr. Mohammad Mustafa, however, says this is not possible. The mother’s kidney does not match that of the recipient and the father’s life would be at risk.
Dr. Mustafa says his patient suffered kidney failure from a sudden rise of Creatinine in his blood after taking Rapiflam 25 mg.
The painkiller had expired and became toxic. Alaa did not know that the medication’s production date had been altered. Sharp contractions in the arteries reduced blood pressure and oxygen flow to the kidney. Alaa needs an urgent kidney transplant, but for now, the doctor has advised him to undergo three Kidney dialysis sessions a week.
Alaa bought his medicine from a pharmacy not far away from his house in Cairo’s Al-Salam City. He had no reason for any suspicion. The production and expiry dates on the packet appeared valid. He took high doses of Rapiflam 25 mg to kill his pain only to find that his situation was worsening.
This tragic case is neither first nor the last in Egypt, where expiration dates of medicines are easily tampered with by gangs recycling outdated medicine they collect from pharmacies.
Yassar, 48, suffered heart palpitations with a racing 100/minute pulse rate during rest. She took Paraffin for six months to lower her blood pressure. It turned out that the medication was expired and had turned toxic, says Dr. Ayman Badawi, an internist supervising her at Banha Hospital.
Abdul Sattar Khadr, 32, regularly took Diclowin 100 mg to treat his stomach ulcer and did not know the medicine was expired. He caught an infection that led to chronic kidney failure.
The three are victims of pharmacies selling expired drugs to get rid of their stock surplus since the Pharmacists’ Syndicate decided to return only 4 percent of unused expired medicine to pharmaceutical companies under a decision taken in November, 2011.
Before that, drug manufacturers were bound to take back all the expired drugs.
The Syndicate’s decision left pharmacists with tons of expired drugs.
Adding to this is a 2009 decision taken by the Health Ministry and setting regulations for safety conditions inside pharmaceutical establishments. The decision, however, was not specific about “allocating a separate place for storing expired medical supplies until they are destroyed or returned to the manufacturing company.”
In other words, the two decisions did not clarify a system for the disposal of expired drugs.
Setting a 4 percent ceiling on discarded drugs prompted pharmacists to sell expired medication to gangs specializing in changing production dates for medicines collected from licensed and unlicensed stores before returning them to the same pharmacies.
This “recycling” turns the active substances into poison in patients’ bodies, thanks to weak controls by the Health Ministry’s agencies and the Pharmacists’ Syndicate. Obsolete laws aggravate the situation further, according to facts documented by this reporter.
The Syndicate’s 4 percent decision was taken in collaboration with representatives of the pharmaceutical companies and drug distribution agencies, the primary beneficiaries of this decision.
Pharmacists’ Syndicate President Dr. Mohammad Abdel Gawad says the decision was made at a time when “large amounts of expired drugs were in the market, which had constituted a real crisis for pharmacy owners.”
Furthermore, Health Ministry laboratories shirk away from testing samples, rejecting this reporter’s request to test the quality of a product sample pending the ministry’s approval.
Pharmaceutical regulation agencies say they are in control of the market but acknowledge difficulties and do not provide updated statistics on their activities.
Dr. Madiha Ahmad, Director of the Health Ministry’s Pharmaceutical Inspection Department, says decisions were made to “shut down 70 or 80 stores by the end of 2012.”
She says: “We follow up well”.
There are 120 local pharmaceutical factories, 3,000 stores, and 63,000 licensed pharmacies controlled by 1,000 inspectors working under Dr. Ahmad’s department in line with the regular protocol.
The inspectors’ total salaries are estimated at 50 million Egyptian pounds ($7 million) a year.
However, the biggest challenge arises from “thousands of unlicensed institutions in Egypt acting as drug stores that deal with citizens and pharmacies. These are actually drug dens that cannot be reached except through complaints filed by the affected,” she explains.
On August 16, 2014, officers at the Health Ministry’s Central Administration for Pharmaceutical Affairs raided a major pharmacy in Ramses, Cairo, and found it dealing with expired medicine bought from an unknown source. Officials moved at the complaint of a citizen who bought “diet sugar” from there. Officers confiscated the medication and issued Police Report 2350 of 2014. The pharmacy owners were referred to the prosecution on charges of dealing in contraband goods.
Dr. Ahmad stresses that the ministry “returns the taxes on the discarded supplies obtained from pharmaceutical companies and verifies their incineration and disposal in sanitary landfills.”
According to Dr. Ahmad El-Beeli, Rapporteur at the Syndicate’s Tax Committee, a 25 percent tax is imposed on the profits of pharmaceutical companies in Egypt.
There is one inspector for every 63 pharmacies. This means he/she must inspect a pharmacy every six days.
Dr. Ahmad El-Azby, Board Director of Pharmaceutical Group Multipharma and owner of El-Azby Pharmacy chains, suggests setting up a computerized control structure similar to the one he uses at his group of pharmacies and linking it to an information network that can be shared with pharmaceutical stores and manufacturers. He also calls for arranging medicine boxes on shelves according to their expiration dates.
El-Azby criticizes the confiscation of medicines by “routine inspection” teams saying that it impossible to control 63,000 pharmacies with such a limited number of staff. He adds that the pharmaceutical inspection department’s mechanism is “based only on complaints after the disaster,” noting that “the highest penalty on expired medicine is a financial fine, which is not enough to deter the medicine recycling mafia.”
El-Azby talks about “big differences between controlling medication in Egypt and abroad, as the 1955 law regulating pharmaceuticals is obsolete and consecutive governments insist on refusing to amend it. They merely patch it up with ministerial decisions.”
Syndicate President Abdel Gawad says that the Syndicate has been pushing for a new law regulating the profession since 2009, but to no avail. He explains that it drafted a new law in 2009 after consulting all concerned parties, to close the gaps of the enforced law since 1955 and to impose stiffer penalties. The Syndicate tried several times to introduce the draft law through parliament’s health committee, but was constantly postponed until January 25, 2011 when the revolution broke out. “Conditions have not settled since and we are still waiting for the new parliament to endorse the new law,” he says.
This reporter visited four licensed pharmacies in four governorates: Giza, Qalubiya, Sharqiya and Munufia. The four pharmacies are clients of the largest pharmaceutical manufacturing and distribution companies.
Pharmacy owners estimate their annual losses from expired drugs at 10 to 15 percent of their total sales. Pharmaceutical companies retrieve only 3 to 5 percent of the medicines, three months before the expiration date. Pharmacy owners also criticize the companies’ failure to pull out “refrigerated” imported medicine – like Insulin and its derivatives, used for diabetic patients, and other types of liquid medicines which can easily spoil if left without refrigeration for more than 48 hours.
To alleviate losses, owners of two pharmacies admitted to selling expired drugs at 50 to 70 percent discounts after the companies refused to take them.
Owners at the two other pharmacies said that they burn the expired medicine at their own personal expense to avoid responsibility. One said they destroy more drugs than the companies are willing to take back.
Former Health Minister Dr. Maha Rabat said of 18,251 complaints were registered against pharmacies by end 2013. Citing prosecution records, she added that the health authorities seized smuggled and unlicensed drugs found in 41 of 51 violating pharmacies. The Ministry ordered the closure of 939 pharmacies and revoked the licenses of 255 others. The Ministry also confiscated drugs in 32 unlicensed outlets. The penalty for opening and managing a pharmacy without a license is at least one year in prison and a fine of EGP 5,000-10,000 ($700 to $1,400).
The Pharmacists’ Syndicate calculates that expired drugs form 3 percent of the yearly total local and imported medicines, equivalent to $96 million. Dr. Abdullah Zain El-Abedine, from the Syndicate, estimates the business in tainted drugs through changing the expiry dates at EGP 400 million ($56 million). The World Health Organization (WHO) said in a 2013 statement that 20 percent of the total volume of pharmaceutical sales in Egyptian markets is expired and tainted.
El-Abedine believes that the 3 percent ratio is acceptable compared to 9.4 per cent of the $75 billion global trade in tainted drugs, estimated at $800 billion. He says that the 4 per cent limit for returning expired drugs is “acceptable to all, especially the pharmaceutical companies that would lose billions if they agreed to retrieve all the discarded drugs and refunded pharmacy owners”.
He stresses that the medicine market is under control by inspectors according to Law 127 of 1955 regulating the pharmaceutical practice. The law imposes stiff penalties on pharmacies promoting expired medication, including prison and expulsion from the syndicate.
Dr. Mahmoud Hussein, professor of internal medicine and Deputy Head of Special Care at Al-Yawm al-Wahed (One Day) Hospital in northeastern Cairo, says that the “recycled” drugs could stop the active substance from working, aggravate the disease, or turn into toxic substances causing chronic and fatal diseases.
Dr. Hussein explains that the risk lies in “breaking up the white blood cells and destroying immunity after sodium and potassium is wiped out in the body, which leads to heart palpitations and death.”
Pharmaceutical companies collect the discarded drugs in their respective stores. They send a list to the Health Ministry’s central administration for pharmaceutical affairs that includes the amount of expired drugs, the reasons for discarding them, the name of the manufacturer and the name of the incinerator or the landfill.
The ministry delegates an inspector to monitor the incineration of the expired drugs. But owners of several incinerator s offer bribes to the inspectors to sign off on the consignment’s disposal. Then they take the expired medicines and give them to the “counterfeit mafia,” which “recycles” the goods after changing their expiry dates, according to dozens of documented records at the Interior Ministry’s Anti-Fraud Investigation Department.
A man at a pharmacy in Cairo’s Al-Sayida Zainab neighborhood, who identifies himself as Mohammad S, says that individuals claiming to represent a pharmaceutical company “came to the pharmacy and offered to buy all the expired drugs”. He says he agreed to sell them what they needed without a second thought. This enabled him to get rid of a consignment of drugs costing EGP 13,000 ($1,867) by selling them for EGP 3,100 ($445).
When more expired drugs accumulated, the pharmacist tried to contact the company only to find out that it never existed. He also discovered that he was not the only pharmacist to have dealt with this “bogus” company. “Everyone sold the expired drugs for a quarter of the cost to this company before it suddenly disappeared,” he says.
The Pharmacists’ Syndicate issued a decision on October 17, 2011 following a meeting attended by the board of directors representing most pharmaceutical manufacturing companies and distribution agencies in Egypt. In addition, the meeting was attended by the Deputy Health Minister for Pharmacists’ Affairs Dr. Ayman El-Khatib; Dr. Mohsen Abdel Aleem, the head of the Cairo branch of the Syndicate and technical director at the office of the minister, the President of the Pharmacists’ Syndicate Dr. Mohammad Abdel Gawad; the Syndicate Secretary-General Dr. Abdullah Zain El-Abidine and Rapporteur of the Pharmacies’ Committee Dr. Sami Farrag.
This reporter visited El-Marg, home to half a million Egyptians, after hearing rumors that many secret stores and factories for expired drugs operate out of the area.
This reporter went undercover, claiming to be a representative of a pharmaceutical distribution agency. He met Mohammad Shika, who enjoys connections to pharmacies, doctors, and patients. After gaining Shika’s trust, he suggested that trading in medicine was an easy and profitable business. He offered this reporter 50 percent partnership in a “major deal”.
After midnight, the two drove through Al-Nahda Street and arrived at an old house. A light could be seen coming out of the second floor. Shika asked me to wait outside until he clears the introduction part. He returned shortly to take me inside, whispering: “Let’s hurry.”
Boxes filled with different kinds of drugs were stored behind a wooden door. Light brown cardboard boxes filled with hundreds of different types of painkillers and vitamins were piled up on the right side of the room. On the side, I saw boxes containing ampoules.
A few minutes later, a middle-aged man addressed by Shika as “the prince,” walked in. After a brief introduction we sat down next to the boxes. Upon noticing that the drugs had expired a year ago, I asked how we could sell them without being caught. The prince laughed and said: “We have the solution … and the customers too”.
When asked about the source of these drugs, he said some were smuggled out of incinerators and others were collected from pharmacies at low prices. He picked up a black bag and pulled out a device resembling a stamping machine with English numbers and dates that he uses to change expiration dates.
Asked where he obtained the device, the prince replied: “This is the easiest thing in this operation. The flea market is full of these machines and no one buys them. I bought it for EGP 200 ($29).
Nearby, two men sat for four hours changing the dates on medicine packs: mostly painkillers smuggled from incinerators in the Ramadan 10 area. This reporter managed to take some photos inside this warehouse showing the amount and types of drugs after their expiry dates were changed. There were no refrigerators or shelves to store the medicine.
Each pack has four slots: “Mfg” for (manufacturing date), “Exp” for (expiry date), “Pt” for (price) and “B.N” or “Lot,” for (batch number).
Strips of medicine are placed in empty boxes made by unlicensed printers in the area. Egypt has 7000 unlicensed printers, according to the Chamber of Industry’s Printing Unit.
Drugs can also be counterfeited by placing a sticker with the production and expiry dates on the above-mentioned slots.
Officials at the laboratory run by the Health Ministry turned down our request to analyze contents of a sample of adulterated medicines taken from this makeshift factory. “We only analyze food and beverages,” said one official.
Employees at the National Commission for Biopharmaceutical Control, a department which specializes in analyzing suspicious drugs, insisted that this reporter presents them an official request signed by the newspaper editor asking for the test and EGP 2,000 ($286) in fees to test the sample. This reporter complied with their request only to be told by one official that instructions by the “Health Ministry” only allow for analyzing samples from pharmaceutical companies or the pharmaceutical inspection department”.
But upon seeing the sample, she said that it visually appeared unfit for human consumption. However, she refused a request to put her initial findings in a formal report, saying that she will do so only upon the recommendation of the Pharmaceutical Inspection Department. At the Inspection Department, this reporter was asked to identify the name and place of the warehouse from where he took the sample. “We will take care of it,” he was told.
Inspection Department Director Dr. Madiha Ahmad explains the steps taken under to test the process of manufacturing drugs, starting with pulling random samples from the raw materials before, during, and after production and ending with their analysis at the National Organization for Drug Control and Research, NODCAR.
Biological drugs such as vaccines, ampoules, and so on are tested and analyzed at the National Commission for Biopharmaceutical Control. She says that a few samples from every local and imported batch of medicines are also analyzed.
The samples are sealed and stamped with a code and are sent to the above-mentioned organizations for testing. If the tests are clear they would be released and allowed into the market through the distribution agencies. But if they fail to pass the quality control test they are banned from the market.
Patients can recognize signs of spoiled drugs, mainly by checking the difference between the batch number on the box and the sticker. The color of the box would be faded, according to Dr. Ahmad, in addition to the low quality of the print on the leaflet inside the box or the instructions on the outside.
She acknowledges difficulties in surveying the expired medicine in the market. Although inspections of expired and tainted medicine take place routinely, “the situation predicts great risk”.
She says that the National Commission for Biopharmaceutical Control does not analyze expired medicine “to check the effect of active substances”. Then they send us a report declaring “expired or spoiled”. If the medicine is not expired “it is analyzed to find whether it meets quality control”.
Meanwhile, if the government and those involved in the production, distribution, and the sale of medications do not change the mechanisms of inspection and amend relevant laws and regulations, Egyptians will remain threatened by different diseases due to the “killer antidote”.
This investigation was completed with support from Arab Reporters for Investigative Journalism (ARIJ)