FDA maintains tight grip on Indian and Chinese products

The U.S. Food and Drug Administration rejected more than 13,000 products made in India in the 5 years between 2010 and 2015, according to FDA data cited in an Economic Times report, and rejected slightly more than 15,000 products made in China.

India's Ministry of Commerce and Industry said the products included many consumer and food items as well as a range of pharmaceutical products and were rejected for "misbranding, problems in packaging, labeling and contamination."

The report said in January alone the FDA rejected 228 Indian products and 314 Chinese products. The rejections then included three drugs from Intas Pharmaceutical and Sanofi's ($SNY) Indian unit.

Kiran Mazumdar-Shaw

Bangalore-based Biocon official Kiran Mazumdar-Shaw told the Economic Times that India's $15 billion drug industry--which has been hit with numerous FDA sanctions over the past year--has problems with "data integrity issues." Several Indian companies have been caught "red-handed" manipulating test data or outright falsifying results, she explained, and others "had issues" with "clean environments" with products being made in nonsterile facilities.

The report also quoted Ajay Sahai, director general of the Federation of Indian Export Organization, as saying if India wants to continue to compete on the world stage, the drug industry has to meet world-class standards and said the industry must go on a "war footing" to fix the problems at India's production plants.

- here's the report from the Economic Times

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