U.S. Heightens Scrutiny of India's Drug Makers ; Rush of Counterfeiting and Wave of Safety Lapses Threaten Major Industry
Harris, Gardiner, International New York Times
American regulators are looking into instances of safety lapses, falsified drug test results and the sale of fake medicines.
India, one of the largest exporters of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by American regulators for safety lapses, falsified drug test results and the sale of fake medicines.
Margaret A. Hamburg, the commissioner of the United States Food and Drug Administration, arrived in India last week to express her growing unease with the safety of Indian medicines because of "recent lapses in quality at a handful of pharmaceutical firms."
India's pharmaceutical industry supplies 40 percent of over-the- counter and generic prescription drugs consumed in the United States, so the increased scrutiny could have profound implications for those consumers.
F.D.A. investigators have been blitzing Indian drug plants, financing the inspections with some of the roughly $300 million in annual fees from generic drug makers collected as part of a 2012 law requiring increased scrutiny of overseas plants. The agency inspected 160 Indian drug plants last year, three times as many as in 2009. The increased scrutiny has led to a flood of new penalties, including half of the warning letters the agency issued last year to drug makers.
Dr. Hamburg was met by Indian officials and executives who have been shocked by F.D.A. export bans on generic versions of popular medicines -- the acne drug Accutane, for example, the pain-reducing drug Neurontin and the antibiotic Cipro -- that the F.D.A. determined were adulterated. The officials said they suspected she was protecting a domestic industry from cheaper imports.
"There are some people who take a very sinister view of the F.D.A. inspections," Keshav Desiraju, India's health secretary until last week, said in an interview.
The F.D.A.'s increased enforcement has already cost Indian companies dearly. Ranbaxy, one of India's biggest drug manufacturers, pleaded guilty to felony charges and paid a $500 million fine last year, the largest ever levied against a generic- drug company. Many companies worry that worse is in store.
"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 an interview with an Indian newspaper, "we will have to shut almost all of those."
A top executive at Ranbaxy pleaded with Dr. Hamburg at a meeting last Tuesday with other drug executives that his products be allowed into the United States so the company could more easily pay for fixes and improvements. Ranbaxy has been caught lying to the F.D.A. on several occasions and found to have conditions such as flies "too numerous to count" in critical plant areas. Dr. Hamburg politely declined.
The drug industry is one of India's most important economic engines, exporting $15 billion in products annually, and some of its factories are world-class, virtually undistinguishable from their counterparts in the West. But others suffer from serious quality control problems. The World Health Organization estimates that one in five drugs made in India is fake. A 2010 survey of Delhi pharmacies found that 12 percent of sampled drugs were counterfeit.
In one example, fake medicines at a pediatric hospital in Kashmir are suspected of playing a role in hundreds of infant deaths there in recent years. One widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab. The test was kept secret for nearly a year while about 100,000 useless pills continued to be dispensed. More tests of hospital medicines found dozens more that were substandard, including a crucial intravenous antibiotic used in sick infants.
"Some of the fake tablets were used by pregnant women in the postsurgical prevention of infections," said M. Ishaq Geer, a senior assistant professor of pharmacology at Kashmir University. …