Indian government stands up to EMA over licence suspensions

The Indian government has come to the defence of GVK Biosciences, the company at the centre of allegations of flawed data used to support the licensing of hundreds of generic drugs.

In January 2015, the European Medicines Agency (EMA) recommended that marketing authorisations for more than 700 generics – licensed on the basis of data from studies carried out by GVK Biosciences – should be suspended.

But India’s department of commerce says there is no evidence “of any manipulation nor any scientific basis” for the allegations originally made against the company by the French drugs safety regulator the National Agency for Medicine Safety (ANSM), which prompted the EMA recommendation.

“For around 300 drugs out of 1,005 products where companies were forced to go for another bioequivalence study (fearing suspension of market authorisation), the results turned out to be the same as by GVK Bioscience,” says a spokesperson for India’s department of commerce.

“The government of India has brought out serious issues of lack of transparency and scientific basis to the notice of ANSM, the EMA and the European Commission, and is expecting a fair and transparent review.”

Following its investigation, the EMA recommended suspension of marketing authorisations unless the drugs were considered by national regulators to be of critical importance. It also stated that there was no evidence to suggest harm or lack of effectiveness of any of the products linked to GVK Biosciences data.

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Citation
The Pharmaceutical Journal, PJ, 18 April 2015, Vol 294, No 7858;294(7858):DOI:10.1211/PJ.2015.20068301