* FDA chief says important for India to work with foreign
* Indian regulator says will follow own quality standards
* FDA visit follows sanctions against Indian drugs firms
By Sumeet Chatterjee and Zeba Siddiqui
MUMBAI, Feb 18 The head of the U.S. Food and
Drug Administration (FDA) called for more collaboration among
regulators to improve drug quality and safety as she wrapped up
a visit to India after recent import bans on drugs from a
handful of plants in the country.
In recent months the FDA has banned the import of drugs and
drug ingredients from leading Indian manufacturers including
Ranbaxy Laboratories and Wockhardt, citing
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
"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
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 standards.
"We don't recognise 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 deliver."
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 sub-standard 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
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 United States.
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 U.S. factory.
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
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 manufacturing standards.