- FDA, WHO reviews of Indian site found manipulation of samples
- Sandoz, Teva, Mylan generic medicines among those affected
The European Medicines Agency called for a halt to sales of hundreds of medicines that were tested in India, after an inspection of the research site found “substitution and manipulation” of study samples.
The recommendation applies to mostly generic medicines from companies including Novartis AG’s Sandoz unit, Teva Pharmaceutical Industries Ltd. and Mylan Inc., and smaller Indian companies like Lupin Ltd., according to an EMA statement Friday. Drugs currently being evaluated using studies from the Semler Research Centre Pvt. site in Bangalore shouldn’t be authorized until alternate data is provided, the agency said.
So far, there is no evidence of unexpected harm or lack of effectiveness in these medicines, the EMA said. The list includes different strengths of the cancer drug erlotinib sold by both Sandoz and Teva, Mylan’s eletriptan for migraines, and atovaquone with proguanil, a malaria pill, also from Sandoz and Teva.
The EMA review, started in April, follows an inspection by the U.S. Food and Drug Administration which identified issues at the bioanalytical site. The World Health Organization had also raised “serious concerns” regarding data integrity and manipulation of study samples after its own inspections of Semler’s bioanalytical and clinical sites.
The regulator’s recommendation will be sent to the European Commission for a legally binding decision valid throughout the European Union. Some of the medicines on the list may be of critical importance to EU member states, and national authorities can temporarily postpone suspending drugs in these cases.
Sandoz is working with its licensing partners to repeat the studies at an
alternate site, a Novartis spokesman said in an e-mailed response to questions.
Sandoz hasn’t worked directly with Semler, it said. Semler is used by Sandoz’s
A call to Semler after business hours in India wasn’t answered. Spokespeople for Teva and Mylan didn’t immediately respond to requests for comment.
The EMA last month backed the suspension of Riluzole Alkem, a medicine that was studied at the Alkem Laboratories Ltd. site in Taloja, India, after an inspection found misrepresentation of data during two separate trials. Last year, the agency recommended the suspension of market authorizations secured using clinical studies done by another Indian company, GVK Biosciences Pvt., after inspections showed a pattern of electrocardiogram manipulations.