By Toni Clarke and Bill Berkrot
WASHINGTON/NEW YORK, March 18 Some U.S. doctors
are becoming concerned about the quality of generic drugs
supplied by Indian manufacturers following a flurry of recalls
and import bans by the Food and Drug Administration.
India supplies about 40 percent of generic and
over-the-counter drugs used in the United States, making it the
second-biggest supplier after Canada.
In recent months, the FDA, citing quality control problems
ranging from data manipulation to sanitation, has banned the
importation of products from Ranbaxy Laboratories Ltd,
Wockhardt Ltd and, most recently, Sun Pharmaceutical
"I'm just beginning to realize the gravity of the problem,"
said Dr. Steven Nissen, head of cardiology at the Cleveland
Clinic. "It's terrible and it is starting to get a lot of
traction among physicians."
Indian drugmakers are by no means the only companies to
recall products or be warned by the FDA about manufacturing
problems. For instance, quality control failures at Johnson &
Johnson forced the company to recall dozens of products
over the past five years, ranging from artificial hips to
And last year, Germany's Boehringer Ingelheim said it would
shut down its U.S. contract manufacturing unit, Ben Venue
Laboratories, after it was cited for repeated manufacturing
violations that led to shortages of the cancer drug Doxil.
India's drugmakers, a $14 billion industry, reject any
criticism that their products are inferior to drugs made in
"We have heard doctors making generalized statements,
without being specific on any product or company," said D.G.
Shah, Secretary General of the Indian Pharmaceutical Alliance, a
trade group representing large Indian drugmakers. "This is a
deliberate and serious campaign to malign the Indian generic
If U.S. doctors come across a medicine that does not meet
quality standards, they should report it to regulators, he said.
"Doctors are not in a position to judge whether manufacturing
processes are correct or not. That is the U.S. FDA's job."
Generic drugs account for nearly 85 percent of medicines
prescribed in the United States and the government is relying on
them to help rein in healthcare costs.
"We are losing control over what people are swallowing,"
said Dr. Harry Lever, a cardiologist at the Cleveland Clinic who
is trying raise awareness of the matter among U.S. lawmakers.
"Now, when a patient comes in who is not doing well, the first
thing I do is look at their drugs and find out who makes it."
Increasingly, Lever said, he is recommending patients seek
out generic drugs from specific manufacturers outside India.
"I'm tending to stay away from India," he said. "There's
something wrong. Too many things are happening."
INDIA DOCTORS HIT BACK
Indian physicians do not share the concerns.
"Our drugs are being sold in many countries and being
accepted, so we have no issues," said Narendra Saini, Secretary
General of the Indian Medical Association, a voluntary body of
215,000 doctors. "How do I know that Western drugs are better
than our drugs?"
A 2012 report by India's parliament alleged collusion
between pharmaceutical firms and officials at the Central Drugs
Standard Control Organization (CDSCO), the country's drugs
regulator, and described an agency that was both understaffed
Saini said physicians trust that the CDSCO is taking care of
the quality and the standard of the drugs made in India.
"We very much trust those medicines," he added.
Representatives of Ranbaxy, Sun and Wockhardt were not
immediately available to comment.
Dr. Joel Zonszein, director of the Clinical Diabetes Center
at Montefiore Medical Center in New York, said he is concerned
about the quality of generic drugs in general, not just those
from India. He cited, as an example, his experience with the
diabetes drug metformin.
"When patients open the bottle of medication it smells like
dead fish," he said. Zonszein did not know which company made
the foul-smelling drug.
Physicians do not have a say in which generic drug a patient
receives, as that depends on which products are stocked by
individual pharmacies. If a patient wants to avoid a certain
manufacturer, he or she may have to change pharmacies.
Doctors may specify that the branded version of a drug be
dispensed, but insurance companies frequently refuse to pay for
Dr. Richard Kovacs, who heads a number of American College
of Cardiology committees and sits on its board of trustees, said
doctors may need to play a greater role monitoring the
medications prescribed by their practices.
"The average U.S. cardiologist has been able to assume that
the drugs were safe and effective. It now appears we need to be
more vigilant as a profession, and assist the FDA by reporting
cases where we are concerned about irregularities in the drugs
supplied to our patients," he said.
HARD TO KEEP UP
FDA Commissioner Margaret Hamburg, who recently returned
from her first official visit to India, is urging greater
collaboration between the two countries. During her visit, the
FDA and India's Ministry of Health and Family Welfare signed a
statement of intent to cooperate to prevent the distribution of
Shortly afterwards, India's drug controller general, G.N.
Singh, said in an interview that the country will follow its own
"The FDA may regulate its country, but it can't regulate
India on how India has to behave or how to deliver," he said.
Some companies seem to be responding to the FDA's actions.
Piyush Nahar, an analyst with Jefferies India Private Ltd
who recently met with a number of Indian drugmakers, said in a
recent report that most companies "have increased their
investment" in compliance and some are considering investing in
U.S. or European facilities "to overcome challenges relating to
both regulations and perceptions."
The array of recalls and warning letters can be dizzying.
Ranbaxy recently recalled more than 64,000 bottles of a
generic cholesterol-lowering drug after doses were mixed up in a
bottle, and Sun began recalling 2,528 bottles of a diabetes drug
after a bottle was found to contain an epilepsy treatment.
Those mix-ups follow a recall in January by Dr. Reddy's
Laboratories Ltd of more than 58,000 bottles of its
heartburn drug lansoprazole due to a microbial contamination.
"It's hard to be sure on a day-to-day basis with the array
of medications that you have to be potentially aware of that
there's a specific problem with a specific medication from a
specific generic manufacturer," said Dr. Elliott Antman, a
cardiologist at Brigham and Women's Hospital in Boston.
The medical community is dependent on agencies such as the
FDA, he added. "The bottom line for me is we have to make sure
they have sufficient resources to do their job correctly."
To Dr. Jason Gaglia, a diabetes expert at the Joslin
Diabetes Center in Boston, the warning letters and import bans
indicate the FDA is doing its job.
"Is it scary? Yes. But to me it means the system is
working," he said.