India to get detailed U.S. FDA data on rejected food, drug imports

FDA sign

India will get detailed data from the U.S. FDA on food and drug products rejected for import, opening a window on company names and the exact nature of problems to allow for quicker remedial action on the domestic front.

The move widens the scope of notifications through the addition of a confidentiality clause with the Export Inspection Council of India, allowing a full report on any rejections, the BusinessLine newspaper said.

Under the new protocol, India will get all details of products exported to the U.S. that are rejected, the status of any appeals and final actions ordered from the U.S. FDA "without delay," the newspaper said.

“The confidentiality agreement, to be in place soon, will allow us to keep a real-time tab on what is happening to our exports and also enable us to try and rectify things as soon as a problem arises so that number of rejections goes down,” an unnamed Commerce Ministry official told BusinessLine.

The agreement arose as part of accords signed in 2014 between the Drug Controller General of India and former FDA commissioner Margaret Hamburg.

Earlier this week, India's Central Drugs Standard Control Organization said it would send staff to drug manufacturing hubs across the country to train workers in good manufacturing practice (GMP) in a multiyear program.

The effort follows years of complaints and regulatory actions by the EMA and FDA for poor quality or false data records and lapses in manufacturing quality.

The Commerce Ministry official said the wider pact with the FDA was also aimed at fixing problems in exports.

“It is not always due to poor quality that an item faces rejection," the Commerce Ministry official told BusinessLine. "Other factors such as not meeting the labelling requirement or the packaging requirement also lead to exports getting rejected. If we know exactly what has gone wrong immediately, and not after a gap of four-five months, we could help the exporter to rectify the situation."

Citing data from the FDA website, BusinessLine said more than 11,600 products from India--from drugs to rice--were rejected in the past 5 years, athough the figure may be lower as successful appeals are not subtracted.

“Once the confidentiality agreement is in place, we will have a more correct picture with us of the actual number of rejections although the U.S. FDA website will not make any changes in the way it records data,” the Commerce Ministry official said.

- here's the story in the BusinessLine newspaper