India launches charm offensive on US FDA

New Delhi: 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 India-made generics.

The move seeks to address US 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 US is the biggest market for us. We are dealing with a lot of care. We want to fight these issues head on,” said Mr Gupta, also executive director at Medicamen, which supplies anti-malarials and other drugs.

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 and rival Wockhardt have been barred from sending drugs to the US 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 and Sun Pharma.

That has hurt India’s reputation as a supplier of safe, affordable drugs. Exports grew by just 2.6 per cent in the fiscal 2014 fiscal year ending in March to $15.04 billion. Two years ago, the growth rate was 23 per cent.

Mr 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.