News Update – May 19, 2008

A recent editorial printed in the Times of India May 17, 2008, described a very serious situation in the generic pharmaceutical industry in India. The editorial stated that from statistics from the WHO and OECD that a very large per cent of the world’s spurious drugs are produced in India.
How much of these “Fake” drugs are making their way to the USA and in the government funded drug programs? If like the editorial states the government of India does not have the inclination or the man-power to control the situation, does the US FDA have the ability to protect the public from these unscrupulous drug manufactures?
The following is some excerpts from the editorial:

FAKING IT

Statistics generated by international organizations suggest that the size and reach of the counterfeit and spurious drugs market in India poses a serious challenge.

The World Health Organization says that 35 per cent of the world's spurious drugs are produced in India. According to the Organization for Economic Cooperation and Development (OECD), 75 per cent of the world's supply of fake drugs originates in India. The Associated Chambers of Commerce and Industry of India (ASSOCHAM) estimates that the annual rate of growth of the fake drugs market in India is 25 per cent.
The bulk of the units manufacturing these drugs are located in UP, Haryana and Punjab.

The health ministry, however, says that barely 8 per cent of drugs are suspect. Conflicting estimates of the problem have prompted the Drug Controller-General's office in India to undertake the world's largest study to assess the size of the fake drugs market. Are 1,000 drug inspectors countrywide not sufficient to monitor the quality of drugs in the market? The infrastructure needed to test the purity of drugs is lacking and existing laboratories are struggling to meet the needs of doctors and patients.

Besides affecting sales of genuine drugs — branded as well as low-cost generics — the fake drug industry is putting the lives of patients at grave risk. There have been reports of diabetics dying after using counterfeit insulin and TB patients becoming seriously ill on account of being treated with spurious drugs. The so-called remedy could turn out to be far worse than the disease, if the prescribed drug contains nothing of medicinal value or actually contains harmful chemicals.

A study is urgently needed for us to assess the problem. But action is even more necessary before the problem gets out of hand.

The American public needs to know where their generic drugs are being manufactured and that such drugs are being tested and the manufacturers being inspected by the USFDA before any of these drugs

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