EU blocks sale of 700 India-made drugs

PARIS • European Union member states have until Aug 20 to suspend the sale of about 700 generic drugs made in India.

The European Commission made the decision after an Indian firm contracted by drug companies to test the drugs was found to have manipulated data.

On-site verifications last year at GVK Biosciences showed irregularities "in each and every one of the nine trials inspected", the European Medicines Agency (EMA) said in May, in a report recommending the suspension.

The broad scope of the problems, which go back to the past few years, "highlights critical deficiencies in the quality system in place at GVK Bio's clinic in Hyderabad" added the EMA.

The company tests for "bio-equivalence" to see if the generic versions of drugs are identical in impact to the original.

Commission officials said there was no reason to suspect the drugs - which include some brands of common pain relievers such as Ibuprofen - had caused any health problems, or that suspending sales would create shortages. "There is no evidence of harm or lack of effectiveness," a spokesman said.


A version of this article appeared in the print edition of The Straits Times on July 29, 2015, with the headline 'EU blocks sale of 700 India-made drugs'. Print Edition | Subscribe