WASHINGTON Feb 21 The head of the U.S. Food and
Drug Administration said on Friday it was not unduly targeting
drug companies in India, which supplies a large portion of drugs
used in the U.S., as the agency cracks down on substandard
medication from abroad.
In recent months, the FDA banned drugs and drug ingredients
from two Indian companies, Ranbaxy Laboratories Ltd
and Wockhardt Ltd, citing quality concerns. Some
Indian officials say the U.S. is disproportionately targeting
Indian companies for enforcement actions.
FDA Commissioner Margaret Hamburg, who recently returned
from a 10-day official visit to India, rejected those charges,
saying that her agency was simply "undertaking our required
regulatory activities" needed to protect public health in the
India supplies about 40 percent of the generic and
over-the-counter drugs consumed in the United States, making it
the second-largest supplier after Canada. Yet quality control
problems have long plagued India's drug industry, largely due to
a weak regulatory system.
In 2012, a report by India's parliament alleged collusion
between pharmaceutical firms and officials at the country's
Central Drugs Standard Control Organization (CDSCO), which
oversees the licensing, marketing and trials of new drugs. It
described an agency that was both chronically understaffed and
The country is trying to improve but the task facing both
local and overseas inspectors is difficult. The FDA has 12
members of staff in India, while about 500 Indian companies are
registered to export drugs to the U.S.
The FDA staff is tasked with fostering communication with
their Indian counterparts and can inspect facilities.
Dr. Amir Attaran, a professor of law and medicine at the
University of Ottawa, noted that "even if you put a huge number
of FDA staff in New Delhi, they have no legal power, no ability
to do surprise inspections, no ability to issue subpoenas or
take other measures to force a drugmaker to open its books."
"They are foreign agents in a foreign land," he said.
During Hamburg's 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.
The statement is not binding and has no enforcement power
behind it. Among other things, the FDA agreed to inform India's
regulatory authorities before inspections so that local
inspectors can observe.
The ink on the statement was barely dry when the drug
controller general of India, G.N. Singh, said in an interview
that India would follow its own quality standards and that "the
FDA may regulate its country, but it can't regulate India on how
India has to behave or how to deliver."
Singh said his agency regularly inspects manufacturing
facilities in India and that it plans to raise the number of
inspectors to 5,000 in three to five years, from about 1,500.
"We don't recognize and are not bound by what the U.S. is
doing and is inspecting," he added.
Some observers are skeptical of India's commitment to
improving quality standards.
Last year, Ranbaxy pleaded guilty to felony U.S. charges of
shoddy manufacturing practices and data falsification and agreed
to pay $500 million in civil and criminal fines. Dinesh Thakur,
a former Ranbaxy executive who blew the whistle on the company
nearly a decade ago, said no one in the Indian government has
contacted him about the matter.
"Clearly this is not a priority for the Indian government at
the moment," he said.
The FDA may be able to ban products from individual
facilities but its ability to impose widespread restrictions on
India's drugs is limited, since the U.S. relies on them so
"The dirty little secret in all this is that we can't do
without Indian products," said Roger Bate, an economist at the
American Enterprise Institute who will moderate a congressional
briefing on global substandard and counterfeit medicines on
Wednesday. "We have to negotiate and pressure because we can't
A group of critics, including Bate, Attaran and Dr. Harry
Lever, a cardiologist at the Cleveland Clinic, plans to attend
the briefing and hopes to put pressure on the White House to
take up the issue of drug quality with the Indian government.
Lever plans to discuss problems he is increasingly encountering
with inferior-quality medicines.
"The Indian government needs to feel some pain on this,"
Hamburg repeated a call she made while in India for Indian
regulators to step up their participation in discussions about
global collaboration on drug production.
"India needs to be a full participant at the table," she