The EMA has recommended that a number of medicines, whose authorisation in the EU was primarily based on clinical studies conducted by the Indian CRO, GVK Biosciences, should be suspended. The recommendation is the result of a review carried out by the EMA of over 1000 pharmaceutical forms and strengths of medicines studied at the GVK Biosciences’ facility in Hyderabad, India.
Concerns over this facility were raised following an inspection by the French Regulatory Authority which revealed data manipulation of ECGs during the conduct of some studies of generic medicines. For over 300 of the pharmaceutical forms and strengths studied at GVK, sufficient supporting data from other sources were available, hence these will remain on the market in the EU as the EMA is satisfied with the available data. For those medicines that lack the data from other studies, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended suspension unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs. The decision on whether a medicine is critical for patients lies with the national authorities of EU Member States depending on the situation in their country. For medicines that are considered critical, companies are given 12 months to submit additional data.
The full list of medicines for which the CHMP recommends suspension is available on the EMA website.