The European Medicines Agency recommended to suspend medicines which were based on clinical studies conducted at GVK Biosciences in Hyderabad and recently confirmed it.
"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.
AdvertisementAs it has taken up the matter with the agency and a few other health regulators in Europe, this could be a further setback for the firm as well as the Government of India.
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."
In January 2015, French medicines agency (ANSM) inspected the company's facility 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..."
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. The CHMP's recommendation will be sent to the European Commission for a legally binding decision.
The Agency said that this decision will apply to all member states irrespective of whether or not they have taken interim measures to suspend medicines.
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. The government has made it clear because it has major stake in our exports we will not take it lightly," he had said.