WHO has recognised counterfeit medicines to be an underestimated danger, especially affecting the developing countries. Lembit Rago, head of drug quality at WHO says, "There is no single country which can be called a safe haven, where there is no counterfeiting. It’s a global problem and it needs global action."18

Multinational pharmaceutical companies are now determined to fight the counterfeiting of medicines. The companies are conducting a check of their products in the industrialised countries. They follow the path that the medicines go from the manufacturer to the pharmacist eventually to the consumers. They organise educational campaigns for medical staff and issue press releases for raising awareness about counterfeiting drugs. However, currently, the companies in developing countries do not have adequate resources to follow suit.

According to the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), most countries lack strict rules and regulations regarding counterfeiting drugs. "The risk of punishment appear more theoretical than real in many countries," says an IFPMA report," judging by the relatively small number of successful prosecutions which are reported."19

In 1990 Glaxo Wellcome, Bayer and Bristol-Myers Squibb established the International Counterfeiting Action Programme (ICAP). In 1999, with more members (currently there are 15) ICAP became the Pharmaceutical Security Institute (PSI), that represented member companies and conducted investigations. However, there is one serious flaw — secrecy within the industry. Companies do not disclose information that could damage their reputation. Unfortunately, that makes the struggle against counterfeiting more difficult. Counterfeiting can kill eventually damaging the sales and reputation of the company.20

There are many reasons for counterfeiting practices, particularly medicines. Fake drugs are easy to manufacture and easily undetectable. Good quality packaging is very important for the counterfeiters to succeed. A major hurdle is surpassed once a workroom for packaging the medicines is located, because mere visual inspection of the medicine cannot detect a problem. Packaging manufacturers and printers do not fall under the scope of medicinal legislation and associated inspection requirements; hence go scot-free. The process in which a patient buys a medicine by itself makes the patient vulnerable. The doctor prescribes the product but in most cases, never sees it. The pharmacist purchases the product from the wholesaler merely by visually inspection and commonly purchases products from more than one wholesaler. This raises the probability of aggravation of the situation.

A peculiar situation in India is that many chemists operate without a proper license. Ashwini Kumar, the Incharge Drug Controller General India, says that each chemist shop is required to be operated by a person who has a diploma in pharmacy. But who checks this? In a study sponsored by the National Pharmaceutical Pricing Authority (NPAA), a government body that helps control drugs in the country it was found that although consumers are aware of spurious drugs, they are at a total loss regarding the reporting of counterfeiting to appropriate officials and getting the medicines tested. Most of the times the medicines go undetected and unreported. "The NPAA", says L M Kaushal, the Deputy Director (Cost)," cannot regulate the spurious drugs market in any way. It is the cheap cost of these fake drugs that attract the consumers in the first place. And since they are unable to differentiate the real from the fake, it becomes easier to sell the counterfeit medicines over the counter."

Even the legal scenario is no better. Says Nasser Kabir, legal advisor to a leading newspaper in India, "The law prima facie is not well equipped to take care of defaulters most of the provisions are archaic and need urgent amendment." Sanjeev Chaswal, a Delhi based lawyerputs forth the fact that majority of the culprits are small drug manufacturers with a turnover of Rs 20-50 million, employing no more than 20 people. These small firms have licences to make generic drugs but since that does not give them much earning, they turn to manufacturing fake drugs. Most of the shanty factories are totally unregulated. In splitting up the process of manufacturing the counterfeit drug mafia is able to shroud its activities in secrecy. The tardy pace of the legal process in India, which causes cases to drag on for years, helps them in getting away with the crime. (see box: Legal fakes)