Four European countries have suspended the marketing authorisations for 25 generic medicines tested by GVK Biosciences at its plant in Hyderabad, India, pending the outcome of an investigation by the European Medicines Agency (EMA).
GVK Biosciences describes itself as India’s leading life sciences company working across five sites in the country. The company is a contract research organisation and provides a “broad spectrum of services to international pharma, agro, biotech and life sciences companies”. The EMA says the decision to suspend the marketing authorisations has been taken at a national level, and the move described as a precaution by the French medicines regulator the National Agency for Medicine Safety (ANSM).
Concerns were raised by the ANSM in May 2014 when it inspected the plant in Hyderabad in May, prompting the EMA to launch a review in September 2014.
The EMA says it is reviewing the reliability of “available” data from 2008 to 2014 for generic medicines “authorised on the basis of studies performed at the site” to determine whether they met good clinical practice guidelines.
The ANSM said in a statement on 5 December 2014 that the four countries — France, Germany, Belgium and Luxembourg — had suspended the marketing authorisation of the generic medicines.
“This decision has been taken as a precaution. No evidence has, to date, led to establish a proven risk to human health or lack of effectiveness of these drugs,” said the ANSM. “There is no risk to treatment interruption [as] these drugs are available in other brands.”
In a statement on its website, GVK Biosciences said: “We believe that the studies conducted are in accordance with the good clinical practice guidelines while we honour the conclusion made by the Committee for Medicinal Products for Human Use (CHMP) and are working with our clinical development customers to provide new data that meets all regulatory requirements.”
The UK medicines safety watchdog — the Medicines and Healthcare products Regulatory Agency (MHRA) — is unlikely to follow the lead of France, Germany, Belgium and Luxembourg.
“There is currently no evidence that medicines currently on the UK market are unsafe and people should continue to take their medicines as prescribed,” it says.
The results of the review by CHMP are due to be published in January 2015.
- This article was amended on 9 February 2015. The original said, in error, that the products had been manufactured by GVK Biosciences.