Fake, counterfeit and unregistered drugs

Recently somebody I know was prescribed a drug by a leading doctor for an intestinal problem. This drug was prescribed after a colonoscopy exam done after an overnight stay at one of the many private hospitals in Colombo. But it was later found out that the hospital actually did not give the patient the drug prescribed by the doctor.

Are you surprised?

This can happen to you. And even if it is not the prescribed drug and it is something else, the hospital could get away with it. What I am talking about is the difference between generic drugs and the original innovator drugs.

The doctor in this case prescribed a drug by its brand name; the hospital decided to a give the patient a drug which had the same generic formula but a different brand name. Is there anything wrong with this? I think yes.

Well here’s something I did not know too until just about two years ago. There are three different types of drugs in the market. The innovator drug, which is the drug manufactured by the company that had invented it through long research and development; the branded generic drug, which is the pharmaceutical drug that is manufactured under reputed brands after the patent of the innovator expires; and then finally there is what is called the generic-generic drug, which is the pharmaceutical available without any brand name attached to it. By the time it comes to the third stage, the drug is in the mass market on the production level.

Recently there was a seminar organised by the US Embassy, Sri Lanka Chamber of Pharmaceutical Industry (SLCPI) American Chamber of Commerce and National Intellectual Property Organization. The objective of the seminar was to address the issue of counterfeit drugs. The US Ambassador for Sri Lanka in her opening speech said something very significant. She categorised imposter drugs clearly into three areas i.e. fake drugs, counterfeit drugs and unregistered drugs.

Are these all one and the same? Generally speaking, yes. But one needs to know about this breakdown. In my view, counterfeit drugs are probably close in composition to the genuine but most likely go against the intellectual property act i.e. by being produced prior to the lapse of the innovator patent period. Unregistered drugs would be those that are marketed against national laws and regulations; and they might be useful drugs or absolute duds. And now we come to the final category – fake drugs. As the name itself indicates these I think are drugs that would be of no use to anyone and would have virtually no benefit in the healing aspect.

Sri Lanka is particularly susceptible to the entry of these illegal or fake drugs as there is a huge counterfeit market operating just across the Palk Strait, says Ananda Samarasinghe, the President of the SLCPI.

“While neighbouring India is also known to manufacture some of the best quality medicinal drugs in the world, we also know about the many cottage industries which operate in their domestic backyards. These illegal entities produce dangerous fake drugs, which are slipped across the border to find their way into our pharmacies, hospitals and finally into the hands of our defenceless families, creating havoc in our otherwise extremely advanced healthcare system in Sri Lanka,” Samarasinghe says.

I could go on further to say that perfectly effective drugs produced by the best companies could become absolute duds if they are not stored properly; one has to only look at the instructions on the packaging – store below a certain temperature, do not expose to light, etc. – all clear instructions by manufacturers on how we need to look after our medication before consumption.

Sri Lanka has one of the finest healthcare systems in the world and when the new Minister of Health took office about six months ago, he has been pushing one line. He has insisted that the pharmaceutical industry supply quality drugs to the nation.

But what is quality? Quality is well defined by the manufacturer and they insist that their agent keeps to it when storing and distributing pharmaceuticals. But once it leaves the care of the manufacturer and local agent, what standards in quality are maintained? This has not been defined clearly in local healthcare and the Ministry of Health needs to put in place a set of guidelines that will press all the stakeholders to work on these standards.

I am sure it cannot be done in a day or a month or even a year but it needs to be done soon enough. Key to the proper administration of our healthcare system is the pharmacy; the place where the pharmaceuticals are received and distributed. It is a well-known fact that prescription only drugs can be bought without a prescription over the counter at almost any pharmacy in Sri Lanka – this despite the rule to the contrary.

That is why I was surprised recently when a leading pharmacy in Colombo refused to give my usual monthly quota; they wanted a doctor’s prescription. I was annoyed at that time, but I knew they were right, self medication can be dangerous.

I went back to that pharmacy with a prescription and bought the drugs. I keep going back to that pharmacy because I know that the drugs in that outlet are stored properly; for one there is air conditioning and AC in this case is not a luxury, but a necessity.

There is another school of thought that doctors should not prescribe drugs by brand names, only by their generic name. I think that idea is rubbish. If you trust your doctor to treat you, then you must trust him enough to recommend the right drug (be it brand or generic). With so much choice in the market, a recommendation from the doctor and not the pharmacist is the safest course.

(The writer, a PR consultant and head of Media360, was previously a mainstream journalist in print and electronic media. He also edits a new media website.)