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 Industries Ltd.
"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
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 children's Tylenol.
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 other countries.
"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 industry."
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 and underqualified.
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
"When patients open the bottle of medication it smells like dead
fish," he said. Zonszein did not know which company made the
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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 unsafe drugs.
Shortly afterwards, India's drug controller general, G.N. Singh,
said in an interview that the country will follow its own quality
"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
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
(Reporting by Toni Clarke in Washington and Bill Berkrot in New
York; additional reporting by Zeba Siddiqui in Mumbai; editing by
Michele Gershberg, Frank McGurty and Eric Walsh)
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