The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / Inspections and Audits

Hamburg, Indian Regulators Sign Inspection Data-Sharing Pact

Feb. 14, 2014

The FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drugmakers’ manufacturing facilities.

FDA Commissioner Margaret Hamburg Feb. 10 signed a five-year accord with Indian Secretary of Health Keshav Desiraju at the outset of a nine-day trip to India, creating a framework for sharing data on matters pertaining to sponsors’ manufacturing, clinical trial and laboratory practice inspections.

The agreement also will allow the FDA to observe inspections conducted by Indian regulators and vice versa. The accord calls for the two sides to hold talks roughly four times a year to assess current collaborations and address any concerns.

Lauding the effort, Amy Hariani, director and legal policy counsel with the US-India Business Council, says the bolstered cooperation between both agencies stimulates a “symbiotic relationship” between the countries.

“We applaud both governments for this positive step and are hopeful that through periodic ‘checkups,’ our two countries can continue to deepen bilateral trade and relations,” she said.

The agreement is the latest effort by the FDA to engage more with its international counterparts through systems that allow it to share real-time information and resources.
The agency already shares similar data with its sister agencies in Japan, the EU, Canada and Australia.

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