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Trinis play Russian roulette with their health
The pharmaceutical industry in T&T is a very lucrative, multi-million dollar business both on the legitimate end and the grey area where drugs are being imported but not registered.
Unregistered drugs have been making their way to pharmacies and supermarkets in T&T via the suitcase trade, online pharmacies, and countries in the region with little or no regulations.
The population is now left in a quandary having to choose wisely as they navigate through a maze of branded and generic drugs. With counterfeit and unregistered drugs now in the mix, the average person is hard pressed to tell the difference.
Trinidadians buying unregistered drugs for diabetes, hypertension, cancer, Erectile Dysfunction (ED), and cardiac issues could be playing medical Russian roulette with their health and lives. Former health minister Fuad Khan said some generic or fake drugs can contain hazardous materials such as paint, chalk, rat poison, arsenic, floor wax, boric acid, antifreeze, brick dust, and paint thinner.
As long as there is a high demand and money to be made, entrepreneurs will supply unregistered drugs to the market for chronic conditions which were most popular, from hypertensive drugs, diabetes medicines, pain-killers, antibiotics, diet pills, corticosteroids, cancer drugs to Viagra.
Sandeep Maharaj, from the UWI School of Pharmacy and lecturer pharmacy administration along with several pharmacy students and a professor published an article in 2009 on Researchgate titled “Suitcase Trading and the Pharmaceutical Industry in Trinidad,” which showed that suitcase traders provided the best prices available to consumers, and it was the number one as well as the most important reason for engaging in the trade.
The article stated that suitcase drugs had no difference in drug quality as compared to non-suitcase drugs and can also be acquired at a cheaper rate of zero-15 per cent. The effect of suitcase drugs on pharmacy sales can be concluded as very positive. In Trinidad it was common for pharmacies to purchase products from unauthorised distributors when supply was unavailable from authorised agents.
Anecdotally, the suitcase trade had significantly impacted on the pharmaceutical industry within T&T. The main incentives for engaging in this trade were the attractive comparatively lower prices for the same product. Maharaj said, however, it was a small study and the situation may have changed.
Drug counterfeiting a US $200-billion business
On the other hand, drug counterfeiting has become a US $200-billion business annually according to the World Customs Organization.
Interpol carries a warning on its website that counterfeit products are harmful and can even be fatal.
The organisation said fake medicines ranged from useless to highly dangerous. They often contained the wrong level of active ingredient–too little, too much or none at all–or an active ingredient intended for a different purpose. In some cases, fake medicines had been found to contain highly toxic substances such as rat poison. In all these scenarios, the person taking the counterfeit medicine is putting their health, even their life, at risk.
One can easily be deceived by counterfeit medicines: they were often packaged to a high standard with fake pills that look identical to the genuine ones. Sometimes a laboratory test is the only way to identify the difference.
Chief executive officer of the Caribbean Industrial Research Institute (Cariri) Liaquat Ali Shah announced last week that counterfeit drugs were even bigger than the cocaine and gun trade worldwide.
Tracking counterfeit drugs
Khan, meanwhile, said during his tenure the Health Ministry was moving to introduce a policy to detect counterfeit drugs using tracking, tracing, and authentication technologies.
Speaking to the Sunday Guardian on Friday, he said “The ministry was working on a policy together with the Chemistry, Food and Drugs Division (CFDD) for all importers of pharmaceuticals to have an identifying number, to streamline the system, but I have no idea what became of the policy.
“Each one would have a specific number that would be stamped on pharmaceuticals so that it can be traced back to the distributor. By doing that you would know if anybody or a pharmacy was bringing in any counterfeit drugs and did not get it from a bona fide distributor.
“If distributors have a number and it was stamped on a package, you can determine where the drug comes from.”
Khan said if an inspector went to a pharmacy and it did not have a proper number on its products, but looked like it was genuine, he can ask where the pharmacy got them from, who was the distributor and have the power to remove pharmacy drugs off the shelves operator.
He said while the pharmaceutical industry in T&T was a very lucrative business, there was tardiness in the Food and Drug division in registering and inspecting drug samples.
Khan said the division should be doing random testing but there was not enough staff, suffered from bureaucratic inefficiency and archaic system that had to switch to a computerized system during his term in office.
He said under the PP administration there were around 12 inspectors, it was not enough and they needed to hire about 25 or 30 more inspectors for drugs and food items.
He said there were also lots of fake foods entering T&T with no proper labelling, some items had Chinese writing with no English and this should not happen.
Trinis beating the system, go to pharmacies you can trust
He said many drugs that entered T&T came from Barbados and were unregistered, but bona fide.
Khan said the Barbados Government subsidised drugs for its citizens, but taking advantage of non-existent registration systems and a developing food and drugs division at best in Barbados, Trinidadian entrepreneurs buy the drugs in bulk cheap, sometimes at cost price or below, and pass through T&T Customs without hassle.
He said they sell the drugs to certain pharmacies that then undercut bona fide distributors and pharmacies.
Khan gave as an example, Norvasc, an anti-hypertensive drug that normally sold at $9.50 per tablet, but because of Barbados and the underhand dealing in unregistered drugs and suitcase traders pharmacies sell the unregistered drug for $5.
He said about 20 per cent of pharmaceutical drugs imported into the country in 2013 were counterfeit and most likely that figure would have increased.
He said many of the counterfeit drugs were bought online and people wanting easy or fast money were driven by greed to turn over a fast profit and to prey on unsuspecting people looking for a deal.
Khan cautioned that buying drugs online was a big risk. The US pharmaceutical society also dissuaded people from buying drugs online.
Khan said the Ministry of Trade was trying its best to bring the Food and Drugs division under its purview and that a committee was put together to work on the registration of drugs.
He said a committee between the health and trade ministries should be resuscitated.
Khan said people needed to go to pharmacies they trust—they are the real gatekeepers.
He urged Health Minister Terrence Deyalsingh to act on these findings.
Pharmacy Board president: Test drugs, non-registered does not mean fake
President of the Pharmacy Board of T&T Andrew Rahaman said an unregistered drug may not necessarily mean that it was fake and it can have the full potency or efficacy of registered drugs.
He was asking the powers-that-be to stop interchanging the term “non registered” with “counterfeit”. Cariri claimed that it tested some 20 drugs yet there was not a whimper of how many were counterfeit, he added.
Speaking to the Sunday Guardian on Friday, Rahaman revealed that many of the popular products and brands sold in large chain stores and supermarkets in the US were unregistered in T&T.
He said they would not be on US shelves if they did not pass the stringent testing by the US Food and Drug Administration (FDA).
Rahaman said many people had been equating the non-registration of drugs with being counterfeit and that was not the view of the board members.
He said the ministry was guilty of double standards, it chastised pharmacies for selling unregistered drugs while using unregistered drugs in its hospitals, and some were life-saving drugs necessary to perform surgery.
Rahaman said in a country where there was efficiency of registration, if it continued to have non registered drugs, the registration process can’t be blamed and called for testing to prove counterfeit as was done in first world countries.
$40k to register cancer drug samples
Rahaman said it took between three and five years for an item to be registered and the Food and Drug division insisted if a supplier or manufacturer did not provide samples, it was not taking their submission of application for registration of the drug.
He said in the case of sample drugs for cancer drugs, they may cost more than $40,000, one vial may cost $8,000 to register and if the batch expires, the distributor may have to come up with an additional $40,000.
Rahaman said if there were too many applications for the year, the Food and Drug division would not take any more.
He said minor changes in the colour of the packaging or a tablet by a manufacturer could result in that product being off the market for years. As an example, Andrews liver salts lemon flavour which has been in short supply for one year.
Rahaman said if a drug was listed as a treatment for four ailments and people were taking it for 20 years and was working well, if researchers found that it could treat six ailments, the drug had to be re-registered and taken off the market for years to the detriment of users.
He advocated that the registration system be fixed, test drugs, employ UWI doctorate chemistry graduates and other Trinidadian graduates from other universities in other parts of the world to work with an expert from abroad to train them for one year, supply them with appropriate reagents and equipment which was less than 0.5 per cent of the budget for National Security.
Deyalsingh: It’s not ministry’s job to fill positions in Food and Drugs
Health Minister Terrence Deyalsingh was contacted Friday and asked several questions.
On when more personnel will be hired for its Food and Drug division, he said that he made the announcement in Parliament that it was up to the Chief Personnel Officer and the Public Service Commission to fill those positions.
Deyalsingh said the ministry had made all applications to have them filled, it was not the ministry to fill them but the PSC.
When asked if the ministry was considering a track and trace system for drugs or numbers for distributors and pharmacies, he said they were considering many options.
After five pharmacies had been investigated for the sale of unregistered drugs, Deyalsingh was asked if there will be more checks, he said that was an ongoing process since May 2015.
He said the ministry had also written to the pharmacy board reporting certain pharmacies for their actions.
He said the fake diabetes and blood pressure drugs that made their way into the Chronic Disease Assistance Programme (CDAP), according to a 2017 report, had already been removed.
Cariri’s Liaquat Ali Shah and Trade Minister Paula Gopee-Scoon did not return the Sunday Guardian’s calls on Friday.
Cariri will be hosting a pharmaceutical counterfeiting conference on April 26 at the Hilton Trinidad and Conference Centre.
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