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Drug licensing

EMA recommends suspending licences for 700 drugs over flawed analyses by GVK Biosciences

The European Medicines Agency (EMA) is recommending that the marketing authorisations for more than 700 generic products be suspended because of flawed studies conducted by GVK Biosciences in Hyderabad, India.

The move by Europe’s medicines safety regulator follows a review of data that were used to support the licensing of more than 1,000 forms and strengths of medicines, including data collected from studies conducted at the Hyderabad site.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) says that some of the 700 products will, however, stay on the market in cases where there is no alternative to meet patient needs.

It also says that there is no evidence to suggest harm or lack of effectiveness of any of the products linked to studies conducted by GVK Biosciences.

There were sufficient data from other sources to support the continued marketing authorisation of some 300 of the GVK Biosciences products under investigation, the EMA adds.

The affected products include Auden McKenzie’s dexamethasone and clonazepam; Dr Reddy’s Laboratories’ valsartan, levetiracetam, pioglitazone and telmisartan; FDC Pharma’s amlodipine; Generics (UK)’s repaglinide, donepezil and esomeprazole; Ranbaxy UK’s alendronic acid; Waymade’s venlafaxine; and Wockhardt’s clopidogrel. A complete list [PDF] is available on the EMA’s website.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) says that if the CHMP recommendation is ratified by the European Commission (EC), it will work with the Department of Health to ensure that patients continue to have access to medicines they need.

The EC is due to consider the CHMP recommendation in the next two months.

  • This article was amended on 9 February 2015. The original said, in error, that the products had been manufactured by GVK Biosciences.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067710

Readers' comments (1)

  • There is an important error in this new report. The products for which the recommendation for suspension of marketing authorisation has been issued are not manufactured by GVK Laboratories. To quote from the EMA information release:

    'A number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, says the European Medicines Agency (EMA)'.

    Thus, the clinical studies were undertaken by GVK but the marketing authorisations are held by other companies.

    The full list of affected products can be found at, and are listed by country in which authorised and the AM holder:

    http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/01/WC500180894.pdf

    Regards,

    Brian Matthews.

    Unsuitable or offensive? Report this comment

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