USFDA to share details of rejected exports with India

| Updated on: May 19, 2016
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To sign confidentiality agreement with EIC for supplying non-public information

In a move that will enable India take early remedial action on exports rejected by the US, the Export Inspection Council of India is signing a confidentiality agreement with the US Food and Drugs Administration for prompt sharing of crucial information related to the rejects.

Details of all Indian products that are rejected, the reason for rejection, appeals filed, if any, and the final action taken by the US will be supplied to the Export Inspection Council (EIC) by the US Food and Drugs Administration (USFDA) without delay, a Commerce Ministry official told BusinessLine .

“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,” the official said.

The EIC and USFDA already have an MoU in place to develop opportunities for cooperative engagement in regulatory, scientific, and technical matters and public health protection that are related to the food products the countries regulate.

A 10-point agreement was signed by the Drug Controller General of India and the former commissioner of the USFDA Margaret Hamburg for cooperation on regulatory matters during her visit in 2014.

At present, while India does get to know when a food consignment gets rejected in the US, it does not get to know immediately the details of who the exporter is and what exactly is being objected to by the US.

“It is not always due to poor quality that an item faces rejection. 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,” the official said.

As per information available on the USFDA website, the agency has refused entry to 11,664 Indian products which includes medicine, bakery products, fried snacks, spices, basmati rice, fisheries and herbal products, over the last five years.

But, Indian officials say that the actual number is lower as the website sometimes double-counts and also does not make corrections when some consignments are eventually allowed after appeals are filed.

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

USFDA has similar confidentiality commitments – a document that sets up the legal framework for FDA to share certain kinds of non-public information with FDA counterparts in foreign countries and international organisations – with at least 75 agencies spread across 30 countries, according to its website.

While most of its partners are in developed countries, the USFDA has also signed confidentiality agreements with agencies in developing nations such as Argentina, Brazil, Chile, Israel and Mexico.

Published on January 20, 2018

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