Cochrane Collaboration College for Policy
College of Humanities and Social Sciences

Increased Scrutiny on Medicines made in India


New York Times, February 14, 2014


India’s pharmaceutical industry is the second largest exporter of over-the-counter and prescription drugs to the United States.  Constituting about 40% of all over-the-counter and generic prescription drug sales, this supply has a profound impact on American consumers. So when, Ranbaxy USA Inc., a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited, pleaded guilty for manufacturing and distributing adulterated drugs, which violates the United States Food and Drug Administration (FDA)’s approval process, American regulators began to scrutinize the safety and quality of medications coming from these pharmaceutical firms. As a result of increased concern for the safety of American consumers, Dr. Margaret A. Hamburg, the commissioner of the FDA decided to make a trip to India in February, 2014 to emphasize the administration’s concerns and enforcements that resulted from the 2013 Ranbaxy’s trial.

Last year, when the FDA inspected 160 Indian drug plants, at least half of those drug plants received a warning letter, and as a result, the country had a ban on exports of generic versions of popular medications because they were determined to be adulterated drugs. The World Health Organization, WHO, estimated that one in five drugs made in India are fake.

Some of the global pharmaceutical industry’s top companies, such as Cipla, have manufacturing plants in India, and follow the FDA’s guidelines. Cipla, exports more than 55% of its production. However, in 2011, Benjamin Mwesige, a pharmacist at the Uganda Cancer Institute in Kampala, stated in an interview that they stopped buying cancer drugs from India all together because a certain shipment of drugs they bought had what he believes were counterfeit Cipra labels.

As a result of increasing scrutiny, and with India’s government doing a poor job in enforcing and regulating drug manufacturing standards, company’s like Cipla are looking to expand elsewhere instead of India.


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