India is launching a campaign to repair its reputation as a global supplier of cheap high-quality drugs, responding to bans imposed by US Food and Drug Administration (FDA) on several suppliers, two top officials said on Tuesday.
As part of the charm offensive, New Delhi has invited global regulators – including the FDA – to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
The move seeks to address U.S. quality concerns that have prompted the FDA to slap a slew of sanctions on Indian generics, choking off growth in drug exports.
“Our quality standards are among the best in the world. If a neutral audit is done, it will find our true capabilities and strengths,” Ashutosh Gupta, chairman of the Pharmaceuticals Export Promotion Council (Pharmexcil), which groups more than 3,700 exporters.
“The U.S. is the biggest market for us. We are dealing with a lot of care. We want to fight these issues head on,” said Gupta, also executive director at Medicamen, which supplies anti-malarials and other drugs to over 80 countries.
Worries about quality control in India’s $15 billion drug industry have come to the fore in the past year as plants run by Ranbaxy Laboratories Ltd and rival Wockhardt Ltd have been barred from sending drugs to the United States after falling short of the FDA’s “good manufacturing practices”.
The FDA has also issued import alerts – allowing the FDA to automatically detain products – to more than 20 Indian facilities since January 2013 on quality concerns, including plants of Ranbaxy, India’s top drugmaker, and Sun Pharmaceuticals Industries Ltd .
That has hurt India’s reputation as a supplier of safe, affordable drugs. Exports grew by just 2.6 percent in the 2013/14 fiscal year ending in March to $15.04 billion. Two years ago, the growth rate was 23 percent.
Gupta said the FDA has issued import alerts over issues of data documentation, testing facilities and procedures at Indian facilities. However, there was no issue with drug quality, he said.
New Delhi plans to strengthen oversight following a U.S. threat to launch a special review of India’s regulation of drug patents and rule on market access to U.S. companies.
It is also inviting Washington to hold broader trade talks once a new government is formed after a general election. Opinion polls show that opposition nationalist Narendra Modi’s Bharatiya Janata Party (BJP) is likely to win the vote that ends on May 12. Results are due on May 16.
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.
The industry, which supplies drugs to nearly 200 countries, is concerned that curbs by the FDA have encouraged even regulators from Kenya and Ghana to seek plant continued…
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