In recent months the FDA has banned the import of
drugs and drug ingredients from leading Indian manufacturers
including Ranbaxy Laboratories and Wockhardt, citing quality
The bans threaten the image and market share of India's $14 billion
pharmaceuticals sector in the United States. India is second only to
Canada as a drug exporter to the United States, where it supplies
about 40 percent of generic and over-the-counter drugs.
"We think this is a critical moment in time, when we have to think
and act in new ways, and that requires real commitment as national
regulators to work as a coalition of global regulators," FDA
Commissioner Margaret Hamburg told reporters.
"And that is why it is so important that the Indian regulator really
joins us at the table, because they are so important in the global
marketplace for medical products."
Hamburg met regulatory and health ministry officials as well as
executives of drugmakers including Ranbaxy and Wockhardt.
Quality was the central theme of Hamburg's visit, which included a
trip to the Taj Mahal.
"It was evident," Hamburg wrote in a blog post on Friday, "that
those responsible for building the Taj and those that are preserving
the centuries-old structure are committed to extraordinary quality."
She said that "vision of quality and care" remained with her as she
met executives from Indian drug exporters.
FDA ACTION NOT BINDING
During the visit, Hamburg and ministry officials signed a statement
of intent to achieve, among other things, "convergence in
regulations in keeping with international standards".
The agreement provides for U.S. and Indian regulators to inform each
other before inspecting drugmakers' plants, so host-country
inspectors can join as observers.
The Drug Controller General of India on Monday told Reuters that he
sees scope for India's Central Drugs Standard Control Organization (CDSCO)
working with the FDA and improving regulatory practice, adding that
the Indian regulator will continue to follow its own quality
"We don't recognize and are not bound by what the U.S. is doing and
is inspecting," G.N. Singh said. "The FDA may regulate its country,
but it can't regulate India on how India has to behave or how to
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Industry officials in India say that weak
domestic regulatory oversight and a lax approach to quality control
by some drugmakers means that a large number of substandard drugs
reach the market undetected.
Singh, however, said his agency inspects manufacturing facilities
in India regularly and that it plans to raise the number of
inspectors to 5,000 in three to five years, from about 1,500 now.
U.S. GENERIC DEMAND
Most of the drugs that Ranbaxy, Wockhardt and their Indian peers,
including Dr Reddy's Laboratories and Lupin, export to the United
States are cheaper copies of drugs with expired patent protection.
Demand for such drugs, known as generics, is rising in the United
States, where the government is pushing to reduce healthcare costs.
With increased demand has come greater regulatory scrutiny in India,
which has the largest number of FDA-approved plants outside the
The FDA inspected 111 Indian plants last year, compared with 72 in
2010, the regulator's data shows. The number of inspections in China
rose to 78 from 48.
Last month the FDA banned imports from Ranbaxy's fourth and final
Indian plant, meaning that the company can only sell drugs from its
The FDA acted similarly in November against a second Wockhardt
plant, which made generic versions of AstraZeneca's hypertension
drug Toprol, citing flaws in the manufacturing process.
As a result of the sanctions, the companies face delays in selling
new generics in their biggest market as well as the cost of hiring
external consultants to ensure compliance with the FDA's
(Reporting by Sumeet Chatterjee and Zeba
Siddiqui; editing by Christopher Cushing and David Goodman)
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