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EU Stops Sale OF 700 Indian-Manufactured Drugs For 'Manipulated Data'

The EU executive announced on Monday that EU countries have until August 20 to stop selling nearly 700 generic drugs manufactured in India.

The move comes after results of tests performed on medications by an Indian drug company under contract were found to be manipulated with, according to the Agence France-Press (AFP).

The tests, run by GVK Biosciences in Hyderabad, India were revealed by the French medicines agency (ANSM) to have been tampered with for at least five years, according to the European Medicines Agency (EMA). The organizations tests the efficacy of generic drugs when compared to the original.

"Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the conduct of trials at the site generally and on the reliability of data generated," reads a May EMA press release.

The EMA's Committee for Medicinal Products for Human Use (CHMP) first issued a recommendation on Jan. 15, 2015 "to suspend medicines for which no supporting data from other studies were available." A later reexamination determined that the concerns were sound, and the recommendation was upheld.

Commission officials struck out comments that alleged the suspected drugs had caused health problems, and that the suspended sales would create shortages.

"There is no evidence of harm or lack of effectiveness," a Commission representative said to the AFP.

While the EU Commission pushes for member states to meet the August 20 deadline, other nations--France, Germany, and Belgium, for example--began suspending sales late last year and earlier this year.

PV Appaji, director general of the Pharmaceuticals Export Promotion Countil in India, estimated that the EU's measure could cost a $1 billion to $1.2 billion dollar loss in exports, the Economic Times of India reported.

Sources: AFP via Yahoo NewsEMAEconomic Times of India

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