US drug regulator rejected nearly 12,000 Indian products in five years: Nirmala Sitharaman

The US health regulator has refused entry of 12,012 Indian products, including drugs, into the American market between January 2011 and March 2016 for various reasons, including adulteration and misbranding, Parliament was informed on Monday.

"According to import refusal report data available on the US Food and Drug Administration (USFDA) website, 12,012 refusals of Indian products were recorded from January 2011 to March 2016," Minister of State for Commerce and Industry Nirmala Sitharaman said in a written reply to the Lok Sabha on Monday.

The reasons given for the refusal include misbranding, adulteration, packaging, labelling, pesticides, unapproved products and the like, she added.

On various measures being taken by the government to improve the quality of products, Sitharaman said.

"... the steps taken by the government include tightening labelling rules and making it mandatory for companies to clearly mention the dates of manufacturing, best-before use and expiry dates and improving pre-export inspection," Sitharaman added.

Other steps include greater emphasis on standards through sensitisation of exporters for compliance of regulatory issues through export promotion agencies and taking up the issues at bilateral trade forums, whenever appropriate, she said.