Over the next couple days, the US Food and Drug Administration (FDA) commissioner, Margaret Hamburg, will be finishing up her visit to India. The visit was prompted by the closing of a fourth Indian pharmaceutical factory by the FDA after it was revealed that multiple manufacturing violations occurred during the production of the over-the-counter drugs. With the closures of so many factories, some are worried that the drugs sent to the United States (US) from India may be fake.
Canada is the largest exporter of pharmaceuticals to the US, but India comes in at a close second. In the last FDA report, it was reported that India supplies 40 percent of all drugs consumed by US citizens. The high consumption number caused a 2012 law to be passed, calling for increased scrutiny of production plants overseas. Last year, the FDA raided 160 Indian plants, causing an outcry from the owners of Indian pharmaceutical companies.
Ranbaxy, a pharmaceutical company that produces some acne and diabetes drugs for the United States, owned one of the factories shut down from these raids and these increased restrictions. The factory was found to have an infestation of flies “too numerous to count” and some medicinal tablets contained hair from the workers at the factory. Last year, Ranbaxy paid a $500 million fine levied by the FDA and plead guilty to felony charges. On Tuesday, despite the violations, the managing director at Ranbaxy, Arun Sawhney, pleaded with Hamburg to allow his company’s products to be imported to the United States. She denied his request.
A 2002 report by the World Health Organization found that, in India’s major cities, one in five medicines sold was a fake. A 2012 survey found that 12 percent of medicines offered were fake or tainted with other substances like talcum powder or chalk. Thousands of deaths to infants, pregnant women, and other Indian citizens have been linked to the production of the drug Maximizin-625, an antibiotic that was being given to postsurgery patients to prevent infection. The drug was useless, containing no medicinal qualities whatsoever. The reports serve as evidence to back up the worries that India may be sending fake drugs to the United States.
Despite these reports, and the deaths of their citizens, the Drug Controller General of India (DCGI), G. N. Singh, asserts that there is nothing wrong with the pharmaceuticals being produced in the country. In an interview with Business Standard, he assured the public that none of the medicines available in the Indian market are unsafe. He does admit that his standards and regulations are different from the FDA’s, because “we follow India’s laws, not the US.” He went on to say that if he followed the US standards, “almost all” the drug facilities in the country would have to be shut down.
The statement does not inspire a lot of confidence to American pharmacies or its customers. Though the violations that shut down the four Indian factories were mostly manufacturing violations and not related to the quality of the medicine produced in the factory, the concern is still very real. If the standards being set by the DCGI are below that of the United States, and those standards have not prevented fake drugs from being sold and used in India, there may be little assurance for American citizens have that India is not, indeed, sending fake drugs to the United States.
By Jonathan Gardner