Counterfeit and spurious medicines are a worldwide menace and threaten the lives of millions of unsuspecting patients.
The Pakistan Manual of Drug Laws defines a counterfeit drug as: “a drug, the label or outer packing of which is an imitation of the original, so as to deceive the consumer.”
Whereas the United States Federal Food, Drug and Cosmetics Act defines a counterfeit drugs as: “A drug which, or the container or labelling of which, without authorisation, bears the trademark, trade name, or other identifying mark, imprint, of device or any likeness thereof, of a drug manufacturer, processor, packer, or distributor, other than, the person or persons who manufactured such a drug.”
These different definitions show that the nature of the problem of counterfeit drugs varies from country to country.
In order to address this issue, the World Health Organization (WHO) has formulated a definition. Countries are encouraged to adopt this definition which defines a counterfeit medicine 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. Consumers are misled by incorrect labels and fake packaging of medicines which contain insufficient or inappropriate active ingredients or other deficiencies. According to WHO definition, counterfeit drugs are products whose true identity or source is unknown and are mislabelled and produced by criminals. Sometimes, a counterfeit drug may pass laboratory tests, but this does not mean that it is a good quality drug.
Substandard drugs can also be considered as counterfeit if a manufacturer gets involved in a criminal activity and produces a substandard product intentionally or deliberately using cheaper and less potent ingredients, to make money unlawfully.
A few months back, a member of the British House of Common, Mr Charles Walker, had identified Pakistan as a “world’s leading hotspot country where counterfeit medicines were produced unchecked”. Mr Walker warned that the funds generated by this trade could be subject to money-laundering or used for sponsoring terrorism.
These are serious allegations that tarnish the image of Pakistan and the credibility of our pharmaceutical companies and their products, along with adversely affecting the reputation of the medical profession. It is disappointing that after reports of wrongdoing, instead of a strong protest from the Ministry of Health or our pharmaceutical industry, there have been only a few vague denials and the matter was brushed under the carpet.
To confront this serious issue, it is recommended and suggested that PPMA should take up the issue and request the Ministry of Health to ensure that on each level i.e. federal, provincial and city:
* Activate Drug Courts which will enforce the Drug Laws in letter and spirit and punish those who violate these laws with heavy fines and even imprisonment.
* Manufacturers, distributors, whole-sellers and retailers should employ properly qualified pharmacists on a permanent basis and have proper storage area for medicines.
* Medical stores should not be allowed to sell any life saving or sensitive drugs without a prescription from a qualified doctor. They should keep a record of the purchase and sale of such medicines in a register, as per international law. The records should be regularly checked by Drug Inspectors and signed/verified by them.
* Unsealed and loose medicines, whether in powder form, tablet, capsules, or syrups, should not be allowed to be marketed.
* People involved in the manufacturing, distributing, whole-selling or retailing of counterfeit and sub-standard medicines should be arrested and punished with heavy penalties and rigorous imprisonment. Their stores and property (where such business is being done) should be confiscated in the name of public safety.
* The same punishments should be awarded to quacks and unqualified doctors, whose number is increasing day by day and has now reached to an approximate figure of one million, spreading from big cities to villages.
* Advertisements of fake medicines, medical equipment, supporting appliances and quacks, should be declared illegal and heavily punishable under the law.
* Strict action must be taken against the use of substandard stents which are being marketed in upcountry cities and have caused serious complications amongst heart patients and have also resulted in fatalities.
* A committee comprising of PMA, PPMA, Pharma Bureau, Druggists Associations and consumer protection organisations should be formed to monitor the above recommendations.
* An awareness campaign should be launched, advising consumers to buy from reputed and well-established medical stores, to always check seals, date of manufacture and expiry and always demand a cash memo.
* Anti-Counterfeit labels should be printed on the boxes of all lifesaving drugs.
Recently, the Federal Investigation Agency (FIA) had busted a racket involved in the sale of spurious and counterfeit medicines from warehouses located at Gaziyani Plaza and Central Mall and a special team was formed to investigate the matter.
The FIA conducted raids at the warehouses in the two buildings and seized a large quantity of smuggled and counterfeit drugs worth millions of rupees and suspects were taken into custody.
During interrogation, the culprits revealed that they received these medicines from various wholesalers, brokers and shopkeepers, who smuggled medicines from the UAE, Turkey, Germany and Saudi Arabia and were facilitated by Customs officers at the Karachi airport.
The chief justice of Pakistan has taken cognizance of this serious situation, which is claiming innocent lives and has forced the government into action. The Ministry of Health has started issuing warnings to manufacturers of spurious and counterfeit products and threatening them with strict action.
To protect consumers from counterfeit products, Helpline Trust has developed a cost-effective, easy to apply, Anti-Counterfeit labels, details of which can be obtained from the Helpline Trust office.
To register complaints against substandard and counterfeit products and services, consumers are requested to visit Helpline Trust website: www.helplinetrust.org.pk and file an online complaint through a Consumer Complaint Form, providing details as asked for in the form.
One can only hope that the honourable chief justice and the Ministry of Health will continue to take action against the menace of spurious and counterfeit medicines, which, instead of healing, are killing unsuspecting patients.
trust@helplinetrust.org.pk