Existence of fake and counterfeit drugs is not just a threat experienced by the healthcare systems of countries like India, Pakistan and African continent but the entire world today. The US, the most advanced nation in the world, is currently facing the problem of fake drugs in its pharmaceutical market despite its stringent regulatory network. The US Food and Drug Administration detected in last February counterfeit sales of Roche/Genentech’s cancer drug Avastin to a number of medical practitioners across the US. The exact sources of this counterfeit drug could not be identified but the US FDA traced the fake batches through several distributors in Canada, the UK, Denmark and Switzerland to only end up with an unlicensed supplier in the Middle East as the possible source. Again in April last, the US FDA had to issue a warning cautioning the public of discovery of a new batch of counterfeit Avastin circulating throughout the US, under the name Altuzan, the brand name for Avastin marketed in Turkey, which is not approved for use in the US. These two instances have shaken the US drug control authorities as there could be more such undetected cases of fake and counterfeit products circulating in the supply chain. While sale of counterfeit pills of Viagra and some non essential drugs is not very uncommon in the US and Canada, detection of fake cancer drug indicates a dangerous trend in the healthcare business. And the fact is that these and other fake cancer drugs still remain in the market causing fears about the safety and traceability of the US drug supply.
In the wake of these cases and a measure of extreme caution to protect the drug supply system, the US government is taking a set of measures to closely monitor all medicines entering its market space. One such move is the plan of the US Congress to introduce Prescription Drug User Fee Act (PDUFA) for branded products. The one version already passed by the U.S. House of Representatives allow the FDA to inspect the manufacturing facilities of foreign companies, or reject their products if they refuse inspection. The FDA will have the right to inspect these foreign companies’ active pharmaceutical ingredients and to block their import if they fail to meet US standards. The US FDA is also planning to introduce a Generic Drug User Fee Act (GDUFA) to curb the import of generic drugs into that country. This Act will empower the US government to fix an exorbitant fee on the import of each generic product category coming from any overseas sources. The US currently imports about 80 per cent of APIs and 40 per cent of generics made in the overseas locations. And one of the key suppliers of these products is India for several years. The proposed fee could range from $35,000 for API manufacturers to $150,000 for finished drug units. Such an exorbitant fee on the import of APIs and generic products could seriously impact India’s pharmaceutical exports to the US. What is required is a global initiative to eliminate the threat of fake and counterfeit drugs as this problem is no more confined to developing countries where drug control is usually weak but to the US and Europe. While these countries need to protect their people from unsafe drugs, their legislative actions should not end up in denying access to supplies of quality and cheap generic drugs to the economically weaker patients there.