Were you aware that India’s pharmaceutical industry supplies 40 percent of over-the-counter and generic prescription drugs? By 2017 India will be the 11th largest drug market in the world. India may be a major player, but is it selling quality prescription drugs? The FDA has found many issues with India’s pharmaceutical drug industry, including safety lapses, falsified drug test results and the sales of fake medicines.
Dr. Margaret A. Hamburg, the commissioner of the United States Food and Drug Administration (FDA) went to India recently to speak with manufacturers about the United States’ concerns. The Indian government feels that the FDA is simply trying to protect American drug manufacturers who cannot compete with the cheaper price of India’s drugs. “If I have to follow U.S. standards in inspecting facilities supplying to the Indian market,” G. N. Singh, India’s top drug regulator, said in a recent interview with an Indian newspaper, “we will have to shut almost all of those.” (NYT, 2/14/14)
The World Health Organization (WHO) estimates that one in five drugs made in India are bogus. A 2010 survey of New Delhi pharmacies found that 12 percent of sampled drugs did not contain the product as labeled. The level of concern led the FDA to ban the import of generic versions of some of the more widely used medications in the US—Accutane, Neurontin and Cipro.
Last year the US Department of Justice took one Indian generic drug manufacturer to court, “[i]n the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA Inc., a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited, pleaded guilty today to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy’s manufacturing facilities in India, the Justice Department announced today. Ranbaxy also agreed to pay a criminal fine and forfeiture totaling $150 million and to settle civil claims under the False Claims Act and related State laws for $350 million.”
Right now the public focus is on India, but there is also great concern over imported drugs from China as well. The US has been able to get permission to inspect Indian manufacturing plants; working with Chinese officials has proved difficult. “China is the source of some of the largest counterfeit manufacturing operations that we find globally,” said John P. Clark, Pfizer’s chief security officer. The United States will only go so far, being dependent on the Chinese, according to a New York Times article, since “crucial ingredients for nearly all antibiotics, steroids and many other lifesaving drugs are now made exclusively in China.”
India has an organization to regulate the drug industry. It has a staff of 323. That’s about 2% of the number employed by the FDA. The lack of oversight keeps the cost of Indian drugs low; there are few inspections and those are limited only to new medications. State health departments oversee any medication that has been on the market for over 4 years. If India has to consent to the FDA inspections and standards, it estimates a 25% increase in the cost of production—a cost that will lead to increased costs for Americans buying these drugs. Is a safer product worth the increased cost?
The New York Times article is focused mainly on the imported drugs coming to pharmacies in the United States. It does not even touch on the vast network of ‘under the counter’ sales of medications. Conduct an internet search for ‘order drugs India’ and you’ll find over 98,000,000 results, many of which are online sellers of medications. People who want to cut medication costs, or are trying to hide certain prescriptions from medical records, are buying from online sites in India, Canada and other countries. And, in many cases a prescription is not required, which means that people are not only buying unregulated drugs but in some cases may be self-medicating without the necessary medical supervision. This online, under-the-counter industry will be much more difficult to control ((impossible?) and is just one more symptom (consequence) of the soaring prices of drugs here in the US over the past years.