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Products Liability Blog Post

FDA Questions Quality of Medicine Manufactured in India

From prescription medications to over-the-counter pain relievers, the safety of drug imports from India are in question. Currently, India is the second largest supplier of prescription drugs and other medications to the United States, which makes the quality of their medications an important concern for individuals in the United States.

The U.S.’ concern received international attention when Dr. Margaret A. Hamburg, commissioner of the U.S. Food and Drug Administration (FDA), traveled to India in February to view the conditions and work processes in place for drugs coming to the United States. In the past year, an increased focus on the quality of medications imported from India led to the following actions:

  • Half of the warning letters issued last year to drug manufacturers were directed at facilities in India.
  • In May 2013, Ranbaxy, USA, an Indian generic drug manufacturer, agreed to pay $500 million and pled guilty to felony charges of manufacturing and marketing adulterated drugs.
  • Generic forms of the drugs Accutane, Cipro and Neurontin manufactured by Indian companies were banned.

An article in The New York Times notes many drug production facilities in India operate under stringent quality control practices that allow India to export $15 billion in drugs each year. Unfortunately, responsible quality control is not the standard of Indian pharmaceutical manufacturing.

The practice of counterfeiting and adulterating medications in India has far-reaching global consequences. While in India, Dr. Hamburg signed a statement of intent with Indian authorities as a first step toward improved oversight and safety of U.S.-bound medications manufactured in India.

As seen in the 2012 meningitis outbreak involving contaminated compounded drugs, adulterated prescription medications injure and kill. If you have been sickened or injured because of poor medical care or by medication you were told was safe for you to take, talk to experienced legal counsel in Southern California.

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Thorsnes Bartolotta McGuire
2550 Fifth Avenue, 11th Floor
San Diego, California, 92103-6612 USA