- Spurious or fake pharmaceutical drugs (Medicines) are becoming a rising concern in the World.
- WHO (World Health Organisation) defines a spurious drug as “a medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.” 1
- 35% of the world’s spurious medicines come from India 2
- Drugs with insufficient active ingredients such as Antibiotics are leading to the rise of antibiotic resistant strains of microbes, known as superbugs. Some organisms such as MRSA (Methicillin resistant Staphylococcus aureus are today the leading cause of hospital acquired infections.
- A study estimated that in 2005, there were more than 18,000 deaths due to invasive MRSA in the United States 3
- The FDA (Food and Drug Administration) has called for all Pharmaceutical drugs, Biological products like blood ,etc. To be barcoded. 4
- Japan calls for similar measures 5
- India has no such policy provisions in the near future
- Bar coding and RFID (Radio Frequency Identification) are being considered to prevent counterfeiting in the US and EU.
I was randomly scanning the news one afternoon when I came across some disturbing Statistics. The newspaper claimed that around 35% of the world’s fake pharmaceutical drugs came from India. The European Union, the US and Japan are seriously concerned about the increasing numbers of fake drugs entering organized set-ups such as Hospitals. Now, why should a biotechnologist be concerned about fake drugs? Well, there is a humanitarian concern, of course. Fake drugs are not like pirated movies or books. These drugs can cause serious harm to patients who depend on life-saving drugs for existence; these medicines can kill! Apart from this there is one area that is troubling epidemiologists, drug developers, Medical fraternity and researchers alike. That is, the emergence of Antibiotic resistant strains of deadly bacteria. These organisms, now known as Superbugs, are the cause of some of the most deadly Hospital acquired (Nosocomial) infections. One well-cited example is that of Staphylococcus aureus a gram positive coccus that appears like a bunch of grapes, it is a common cause of Skin ailments, suppurative infections of burns and wounds and Toxic shock syndrome (TSS). There was a time when antibiotics of the penicillin family could be used to cure these infections. However, in recent time, to our growing horror we have seen emergence of a strain of S. aureus that is resistant to the most strong of all drugs and that is methicillin. This organism that is now known as MRSA, (Methicillin Resistant Staphylococcus aureus) is responsible for around 18,000 deaths in the US, (Statistics 2005). There are many such organisms that have emerged in the recent past.
I am sure you can see the tenuous connection emerging. The WHO has a detailed definition of what it terms spurious medicine. One of the key elements is that any formulation containing lower concentrations of the active ingredient than that which the packaged product claims is considered spurious. How does this connect with drug resistance? It is simple. Suppose, for purpose of illustration we consider that 10 units of an antibiotic are required to eliminate a particular infectious agent. Now, instead of that, if I consume, say 5 units, this dose is not the effective dose. It may eliminate some of the bacteria, but some of them will not be killed. They will simply become dormant. Now when populations of bacteria are exposed to sub-lethal doses of antibiotics, a fraction of the population will mutate to become resistant to the antibiotic in question. These initial populations will then be shed by the patient and will mingle with populations in the environment, passing on the genes for resistance by several methods of gene transfer. Over a period of time, we will have more diverse organisms becoming resistant. Thus a vicious cycle is set into motion.
Apart from rampant prescription by doctors and irresponsible behaviour of patients, spurious drugs have contributed significantly to the rise of these super-bugs. And so we now need to seriously think of alternative methods to prevent possible duplication of drugs. Well, the beginnings are being made by the FDA (Food & Drug Administration). The FDA has called for application of Barcodes to all Pharmaceutical Drugs and Biological products such as blood that are distributed through hospitals. This move is primarily to prevent deaths due to administration of wrong medicines to patients. However, the idea of having a uniform barcode system for all drugs even at local outlets such as Pharmacies might be a good idea to consider. The Association for automated Identification and Mobility in a article by editor Bert Moore wrote, “Last month saw actions by both the US and European Union (EU) that demonstrated concern about the security of the pharmaceutical supply chain and a serious intent to stem the growing number of counterfeit drugs entering the supply chain. The US Senate passed legislation with product authentication provisions and the EU heard from the European Federation of Pharmaceutical Industries and Associations on proposed means to halt counterfeiting.” A similar decision has been taken by Japan. The US Senate passed the Food and Drug Administration Revitalization Act (S.1082) that specified the use of “overt optically variable counterfeit-resistant technologies” (sec. 514). “The intent of this legislation is to ensure that pharmaceutical authenticity can be verified without the use of any type of scanner, microscope or any other specialized reader.”
The central idea of this is to have a unique identifier for all pharmaceutical products which can be synchronised, if possible at an international level. The US is concerned about the non-US based online Pharmacies that are emerging at an alarming rate. These pharmacies are now becoming a route to introduction of spurious medicines into the US. Thus a unique code on the package of the drug and a possible means to link individual pharmacies to the database of the suppliers will enable the checking of counterfeiters. Reproducing barcodes on difficult surfaces of packages is expected to be a difficult task for counterfeiters. Similarly, the punitive action on counterfeiters must be tightened. During the time taken for putting systems into place for uniform barcodes, we think of measures like tamper proof sealing or incorporation of holograms that will be easy for the end-user to identify. The incorporation of a uniform code will help manufacturers too in order to curb losses that are eating into their profit margins.
There is an urgent need for authorities in India as well to take cognizance of this very dangerous and criminal activity. There are shocking reports of China manufacturing fake drugs and labelling them as “Made in India”. If we are to safeguard our industry from such malafide intent, the setting up of a uniform identifier with the necessary databases to link up all information at a national and later at an international level is absolutely essential. In order to deal with small pharmacies selling over the counter medications that might be spurious, initially, the government can make it necessary for all Hospital related pharmacies to have bar-coded products only. Patients then have a choice to go only to such pharmacies. Non- hospital connected pharmacies can be given incentives such as tax- rebates if they stock only bar-coded products and satisfy regulatory authorities in this respect.