The European Medicines Agency confirmed its recommendation to suspend a number of medicines in EU countries based on clinical studies conducted at GVK Biosciences in Hyderabad.
“This is the outcome of a re-examination requested by marketing authorisation holders for seven of the medicines concerned,” a statement from the Agency said on Friday.
This could be a further setback for the firm as well as the Government of India since it has taken up the matter with the agency and a few other health regulators in Europe.
During the re-examination, the Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that “concerns about reliability of the clinical studies remain... maintained its recommendation of January 2015 to suspend medicines for which no supporting data from other studies were available.
This is with the exception of one medicine included in the re-examination for which concerns about studies were addressed,” the statement said.
The January action followed an inspection of the company’s facility here by French medicines agency (ANSM) that raised concerns about how GVK conducted studies at the site on behalf of marketing authorisation holders.
“The inspection revealed data manipulations of ECGs during the conduct of some studies of generic medicines...”
No evidence of harm
The CHMP, however, noted that there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad.
Some of these medicines may remain in the market in some countries if they are of critical importance for patients because alternatives cannot meet the patients’ needs.
Next, the CHMP’s recommendation will be sent to the European Commission for a legally binding decision.
This decision will apply to all member states irrespective of whether or not they have taken interim measures to suspend medicines, the Agency said.
Pharmaceuticals Export Promotion Council of India Director General P.V. Appaji had recently said the Centre felt that “it is not scientifically proved and the Commerce Ministry, Pharmexcil took up the issue. A delegation under Joint Secretary to the Commerce Ministry had met health regulators, including EMA authorities. A presentation on the GVK Bio issue was also made by the Ministry when a team from EU Commission was in Delhi last month. The government has made it clear because it has major stake in our exports we will not take it lightly,” he had said.
