http://www.chowk.com/show_article.cgi?a ... sity%20aveCounterfeit Medicines: A Public Health Policy Failure
Zaheer Ud din Babar
December 31, 2005
Recently more complicated and diverse issues about medicines have emerged. Governments, policy makers, academic institutions and civil society groups are addressing safety, efficacy, quality and access to medicines in an increasingly complex and global environment. In this situation, counterfeit drugs are emerging as a worldwide dilemma: they are not only threatening the healthcare system of developing countries but also posing challenges to the developed nations. According to the World Health Organization, a counterfeit medicine is one, which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeit drugs may contain wrong active ingredients, wrong amounts of the ingredients or no active ingredients at all. Counterfeit drugs result in death or disability and are becoming leading causes of therapeutic failure and disease resistance.
The Food and Drug Administration (FDA) states that 10% of all drugs sold in the global medicine market are counterfeit. According to WHO, 25% of the drugs consumed in developing countries are fake. Counterfeit drugs are a major concern in the growing economies of Thailand, Cambodia, Vietnam, Philippines and Indonesia where their prevalence is about 10%. In Vietnam an investigation shows that 64% of antimalarial tablets contained no active ingredient, which eventually led to the death of patients. In India 7% of medicines were found counterfeit and Indian companies were accused of exporting counterfeits to African markets. Counterfeit drugs are 40-50% of all the drugs present in Pakistan. Pakistan is considered one of the 13 countries of the world where the manufacturing of counterfeit medicines is on the rise. The situation is alarming, as the country is also alleged as being a counterfeit hub- exporting counterfeit drugs to North America.
"The World Medicine Situation" by WHO states that Pakistanis are spending 77% of their household health budgets to buy medicines. An irony is that half of these medicines, which are being bought with their hard earned money, are fake. The large-scale presence of counterfeit drugs not only creates distrust of the existing healthcare system but can also have serious social and economic implications. This in turn shows a public health policy failure and depicts that our drug regulatory and legislative authorities have failed to ensure effective and safe drugs for the nation. Counterfeit drugs are the final nails into the coffin of Pakistan's ailing healthcare system.
The question of counterfeit prevalence could be tricky as the Pakistan Pharmaceutical Manufactures Association (PPMA) states that the rate of production of counterfeit drugs in the country is only 0.4 percent. One wonders how industry gets this figure? If it is true, then why are so many fake drugs flooding our markets or why other countries are blaming us as an exporter of counterfeit medicines? Pharmaceutical industry statement could be flawed or could be a mere attempt to conceal the gravity of problem. The pharmaceutical industry in Pakistan always hails its technological achievements and a lot of companies claim to get ISO or FDA standards and many more are eager to join the bandwagon for export purposes. But regarding the core issues of safety and medicine use, industry has failed to show a logical and reasonable response. If Industry wants to play a vital role in the nation's health (as it claims), it definitely has to broaden its vision.
In order to understand the consequences of counterfeit drugs, reliable data are vital. Unluckily, the information about counterfeit drugs lacks at the national and international levels: as industries and governments are both very secretive about the issue. Industry has its reason to conceal because this could damage their reputation and defame their products. Revealing data could also pose problems for the Ministry of Health. In Pakistan, as the scale of problem is large, correct information is essential to address the issue. The complexity of the situation is grounded by the fact that in many cases, companies know about the availability of a particular counterfeit drug but they don't share the information with the consumer.
The pharmaceutical trade is a lucrative business in Pakistan. Many wholesalers, distributors and retailers, who have insufficient professional knowledge, are running these businesses. The problem is further aggravated by the weaker enforcement regulations and the lack of competent and committed regulatory personnel. There could be gaps in the medicine trade cycle- from the manufacturer to wholesalers, distributors and retailers and then to end users, which give the way to slip in, or to proliferate, counterfeit medicines. News reports have highlighted that some of the pharmaceutical companies are producing more than the declared stock of registered drugs. While the drugs from Peshawar, Lahore and Quetta after getting mingled with the counterfeit versions are sold in Sindh.
The presence of counterfeit drugs in the market also has some other implications. Sometime they are used as an excuse to establish the market for branded drugs, by stating them as high quality medicines. Prescribers are given a notion: that majority of the counterfeit could be generic which could be misleading. This could not only be a deception but could also have economic consequences -it could be heavy on the purse of consumer.
There is a need to adopt a national policy on counterfeit drugs. The government has to be vigilant to curb this menace and various means of anti counterfeiting should be discussed. The WHO Western Pacific Regional Office has started a web based communication network, which is called the Rapid Alert System (RAS). RAS involves the focal persons and agencies in the various countries and the purpose is to identify and gather data about counterfeit drugs. The Ministry of Health (MOH) can set-up a central secretariat whereby links can be established with the affected countries for exchange of information.
The Ministry of Health needs to empower its enforcement agencies for proper vigilance. All the government activities relating to counterfeit medicines should be published on a website. The website can also be used as a focal point for disseminating information and also an interacting source between different stakeholders. Another important tool to counter this hazard is to establish more Drug Testing Laboratories (DTL). The DTL structure should be renewed with increased emphasis on training personnel. The DTL should also be equipped with state of the art facilities.
The responsibility to tackle this problem does not only lie with the government. All stakeholders must be involved and should join forces against this menace. The pharmaceutical industry should come up with innovative plans related to consumer health; it will help to build up their reputation as a responsible stakeholder. The professional societies like the Pakistan Pharmacist Association and the Pakistan Medical Association should not be dumb about the issue but should chart out their own strategies for awareness and in combating counterfeits.
Close monitoring of the drug distribution channels are needed and various law enforcing agencies can play a pivotal role. Stricter penalties and laws must be imposed on those who are convicted. All the data about sale or purchase of the drugs must be properly monitored and the drug supply chain must be transparent. Chemist and druggist associations in Pakistan claim to play an important role in the medicine trade, their roles must be redefined and the activities must be streamlined and regulated.
Consumer education is also important and the public should know basic ways of identifying counterfeit medicines. The MOH should start campaigns, continuing education, and refresher courses for those who are involved in the pharmaceutical trade. Counterfeit medicine issues should be included in the syllabus and must be taught to pharmacy, medicine and other healthcare graduates. New laws to curb the counterfeit drugs must be invoked and Industry must be bound by the state to share data on counterfeit drugs- so that the consumer can be kept well informed.
Regulatory authorities could also enforce anticounterfeit techniques. Some of these techniques are holograms, color shifting inks, and watermarks. A hologram is a security label with having a unique serial number, which verifies that the product has been registered with the country's drug control authority. Radio frequency identification tags (RFID) can also be used as a measure to stop counterfeiting. This technology uses tiny microchip capable of storing and transmitting information.
