Times of India had reported that in June 2009 that Nigeria’s drug regulatory authority had seized a large consignment of fake anti- malarial drugs that were made in China but stamped “Made in India”.
In November 2008, Interpol announced that the police across Southeast Asia made 27 arrests in nearly 200 raids carried out with the support of WHO and the World Customs Organization officials across a number of countries and seized fake drugs worth $6.6 million.
Moreover WHO estimates that less than one per cent of the drug supply is counterfeit in countries with strong regulatory oversight as is the case with US and UK, but where the regulatory structure is lax, counterfeits may be much higher. WHO estimates that 20 per cent of medicines in India are counterfeit. According to the US- based Centre for Medicines in the Public Interest, counterfeit drug sales will reach $75 billion globally in 2010.
With about one million people dying in developing countries because of consuming counterfeit drugs, people are left with little trust in medicines they take. “The pill taken to cure can kill them”, says a report.
With so much ado about counterfeit drugs, we must first understand what is the meaning of counterfeiting. WHO currently defines a counterfeit as “a drug that has been 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.
Factors encouraging counterfeiting
According to WHO, increasing international trade of pharmaceuticals and sales via internet has facilitated the entry of counterfeit products into the supply-chain. Lack of regulatory control, lack of political will to combat the problem, corruption and conflict of interests are also the reasons for promotion of counterfeiting activities.
Distribution and sales of products through unauthorised outlets, lack of rigorous enforcement of existing legislation, absence of or lenient penal sanctions for violation of drug legislations may be considered another powerful causes for flourishing counterfeiting.
Excessive demand exceeding the supply of drugs, availability of sophisticated equipment for the manufacture and packaging of drugs has increased the difficulty of detecting counterfeit products.
Ineffective co-operation between regulatory agencies, police, customs services and judiciary has also led to increase counterfeiting activities.
Drawbacks of counterfeiting
Counterfeit drugs are rarely efficacious and in many cases, they are highly dangerous and detrimental to public health in terms of human suffering and increased burden of health care costs. The best suited statement here is “At the best these will be waste of money, at the worst they can harm or even can kill”.
Treatment with ineffective counterfeit drugs may be highly deleterious for example: incorporation of Di-Ethylene Glycol in pharmaceutical preparation fraudulently or by mistake had caused death of more than 500 people mostly comprising of children. Internet sites selling fake contraceptive pills and patches had lead to innumerable unwanted pregnancies in women.
Most recently FDA had warned to be extremely cautious when purchasing any medication over the internet claiming to prevent or treat H1N1 influenza virus as some of the tablets were found to contain talc and acetaminophen, but none of Tamiflu's active ingredient oseltamivir.
With regard to infectious diseases, the inadequate drug formulation or content leads to a sub- therapeutic dose and the development of drug resistance of infectious agents. This in turn will lead to increased morbidity, mortality and significant economic burden.
In wealthier, developed countries, the most frequently counterfeited medicines are new, expensive lifestyle medicines such as hormones, steroids, antihistamines and Sildenafil. In developing countries, most counterfeited medicines are those used to treat life-threatening conditions such as malaria, tuberculosis, HIV/AIDS.
Role of global organisations in fighting counterfeiting
As the counterfeit drug manufacturing industry is growing leaps and bounds, even more faster than global pharmaceutical industry, it is the prime duty of various international organisations to join together to suppress this industry.
First address to the problems of counterfeit medicines was in 1985 at the Conference of Experts on the Rational Use of Drugs in Nairobi. The meeting recommended that WHO, together with other international and non-governmental organizations should study the feasibility of setting up a clearing house to collect data, and to inform governments about the nature and extent of counterfeiting. Then in 2006, WHO created first global partnership known as the International Medicinal Products Anti-Counterfeiting Task-Force (IMPACT) to fight against fake drugs and create awareness among public. IMPACT is focussing mainly on five areas of legislative and regulatory infrastructure, regulatory implementation, enforcement, technology and risk communication.
With the growing menace of counterfeit drugs, who should be held responsible for this? Regulatory bodies, government, manufacturers, sellers or consumer? According to IMPACT, at national level, governments, law enforcement agencies, health professionals, the pharmaceutical industries, importers, distributors and consumer organisations should adopt a shared responsibility in the fight against counterfeit drugs.
Counterfeit medical products being a major global challenge, it requires a strategic approach throughout the world to tackle it. Various strategies for fighting counterfeiting are discussed in following sections.
Radio Frequency Identification
The worldwide pharmaceutical industry is stepping up to reduce drug counterfeiting. Technologies like barcodes have been implemented to secure their supply from the plant to distribution outlets. But the desired results are not achieved due to limitation of the barcode technology. RFID provides unique ID to individual drug packages. It also helps in authenticating the drug packages based on its unique ID.
RFID secures the drug supply chain, benefiting manufacturers, distributors, pharmacists as well as consumers. It also enables customers to check the authenticity of the drugs they are purchasing from any of the retail medical stores. Each package of drug is tagged with an RFID tag with a unique ID, which becomes unusable when peeled off the package. The tag contains relevant encrypted data like batch number, company ID, date of manufacture, expiry date etc.
RFID serves the goal of patient safety by authentication as well as controlling the prescription medications through the distribution chain. It provides transparency to products movement through the supply chain. Companies can also monitor distribution details of its supplies. Even FDA has recommended the use of RFID technology in the US.
Technology to identify counterfeits
A team of Swiss engineers and pharmacists have built a low cost machine to help poor countries detect counterfeit medicines. It is due to be launched in Mali. The technique uses very little sample and has low analytical cost. Such more technologies can be developed and implemented for easy identification of counterfeits.
More and more numbers of laboratories for testing of drugs should be established for easy and precise detection of counterfeits or substandard drugs. Laboratory personnel should be extensively trained for identification of counterfeit from the authentic medicines.
Law
Counterfeit drugs pose a threat to public health and life, which may result in mortality or morbidity. Hence counterfeiting should be criminalised as an assault or other crime. Harmonising criminal laws regarding counterfeiting will prevent criminals from “forum shopping” to find countries where they face no consequences of this behaviour. Judiciary should impose harsh monetary penalties as well as imprisonment to stop their actions.
Reporting to authorities
Compulsory reporting to authorities, regarding any incidents in which counterfeits are detected or involved, can help to reduce counterfeiting. Consumers can be educated regarding reporting procedures. Reporting centres should be made available on grass root levels. Online reporting facilities should be made available at national level as that of one made available by FDA in US.
Strengthening political will
Political will and strong commitment of government are essential to improve drug control and decrease the incidence of counterfeiting.
Government responsibilities include:
● Enactment / revision of appropriate legislation.
● Establishment of adequate drug control institutions with appropriate powers in legislation
● Provision of adequate training for drug control, customs and law personnel for inspection of documents and identification of counterfeit drugs.
● Establishment of specific import procedures.
Developing SOP & guidelines for drug inspectors
These include:
● Examination of documentation
● Visual inspection and other non-analytical checking procedures for detection of counterfeit drugs
● Sampling size, methods and procedure for analysis
● Methods and special precautions for isolating and preventing further distribution of suspect drugs.
● Methods of seizing and destroying counterfeit drugs.
Role of pharma industry
Pharmaceutical industry has a great role in detection, control and eradication of counterfeit drugs. Manufacturers should develop measures such as introduction of security systems including use of security tags to prevent the counterfeiting of their products. They should secure their own stocks of medicines and packaging materials to prevent their diversion to illegal manufacturers. They must regularly survey their distribution channels.
Importers
They should ensure that the drugs which are imported are being manufactured legitimately in the countries they are manufactured. They must import drugs from appropriate source form which they remain satisfied for integrity and authenticity of drugs. They must establish an audit trail of imported drugs. They must conduct visual inspection and other analytical checking procedures on drugs.
Wholesalers and retailers
They must purchase drugs from legitimate sources only. They should avoid purchasing, selling or supplying suspected drugs. They must also carry out visual inspection and other non- analytical methods of checking the quality of drugs. They must also maintain audit trail of drugs they purchase. They must employ suitably qualified pharmacists for drug procurement.
Consumers
The general public should be encouraged to fight against fake drugs. Education and information campaigns should be carried out for general public. Consumers should be encouraged to report to national registration authority or police, if they come across any suspected products. Consumers should be educated to report their physicians if (1) any lack of improvement in their health status in spite of their compliance to treatment (2) all ADRs experienced during treatment.
Consumers interested to buy safe and effective drugs online should make purchases from sites that have “Verified Internet Pharmacy Practice Sites (VIPPS)” seal. One can verify and get list of reputable online pharmacies from www.nabp.net/vipps/
In the end we can say that counterfeits causing serious damage to the health and economy of the people around the world should be dealt with strictly. This is the duty of not one or two people but the whole nation to ensure safety of the coming generations.
-M.S.Ganachar is Professor & Head, Soham Shah, Nidhi Zalavadia, Mahendra Kumar are faculty, Dept. of Pharmacy Practice, KLEU’s College of Pharmacy.