Indian Medicines Banned by the FDA
Medicine in the U.S. will no longer have a "made in India" label following the latest decision made by the Food and Drug Administration (FDA).
The FDA has denied major Indian drug manufactures the right to export their products to the U.S. This is following a inspection conducted by the FDA in cooperation with the Drug Controller General of India, which found that two major drug providers of India did not meet FDA standards.
The companies in question, Workhardt Limited and Ranbaxy Laboratories, have been banned from selling medicine in the U.S. after their products were found to contain ingredients from certain plants considered dangerous to public health by FDA regulators. Ranbaxy organization, which was reportedly already under FDA investigation, wound up having to pay a $500 million dollar fine for not meeting FDA safety requirements.
Interestingly, this isn't new news. India based drug companies have been having trouble adhering to FDA regulations for years due to the questionable nature of their products. The Indian drug market is saturated with placebos, fakes, and unproven treatments. According to the World Health Organization (WHO), about 12 percent of even corporately produced Indian drugs approved by the Drug Controller General of India are considered unauthentic by WHO standards.
Following this latest move by the FDA, Indian business leaders have agreed to help improve regulation of Indian medicine manufactures so that they can meet U.S. standards. Under this decision, Indian pharmaceutical companies will be required to submit past records and commence new safety testing under FDA guidelines for all their products. The FDA has even established an Office of Pharmaceutical Quality in India to oversee the regulation procedures.
Companies that can quickly comply with FDA demands may be allowed to once again sell in the U.S. once again by next year.
Feb 17, 2014 02:25 PM EST