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
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
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. …