Late last week the European Medicines Agency (EMA) recommended the suspension of a number of products that relied solely on bioequivalence studies conducted by Semler at its facility in Bangalore, India.
It also said medicines current under review which use on studies conducted by Semler should not be approved until bioequivalence is demonstrated using alternative data.
The regulator's advice is based on concerns raised by the World Health Organisation (WHO) and the US Food and Drug Administration (FDA) in April. Both said they discovered evidence of data manipulation and recommended that studies be repeated.
Novartis Sandoz unit, which is one of the manufacturers whose products the EMA said should be suspended, told us Semler had tested its drugs as a result of third parties.
A spokesman said: “We have not worked directly with Semler Research. Semler has been used as a contract research organization by our licensing partners.
He added that: “We are working with our partners to repeat the bioequivalence and bioavailability studies at an acceptable alternate study site and to strengthen governance and monitoring of contractual research organizations.”
The EMA also recommends that Teva Pharmaceutical Industries’ antimalaria medication Atovaquone-Proguanil be suspended.
A spokesman told us “We are aware via the European Medicines Agency that Semler Research, an Indian-based CRO has been subject to a recent GCP inspection by the WHO and the US FDA – critical findings and deficiencies were identified. TEVA has never used Semler for any clinical study for in-house developed products.
He added that “we are taking steps to withdraw that product [Atovaquone-Proguanil] in Belgium, Denmark, Finland, France and the Netherlands as requested by those authorities.”
The agency also recommends that several drugs for which Teva is trying to win approval are not cleared until the firm provides alternative bioequivalence data.
The spokesman said: “We are actively responding and involved to the Article 31 referral procedure coordinated by the EMA. We support the industry association Medicines for Europe calls to strengthening international inspection cooperation in the area of Good Clinical Practices (GCP).”
Some of the manufacturers with products on the EMA list have already completed alternative tests.
A spokesman for Micro Labs told us “some of our products got affected due to EMA decision on cancelling all the studies done at Semler CRO.
He added that Micro has repeated all the bioequivalence studies and “we expect all the products shall be back in the respective EU markets by September or October.”
Semler did not respond to a request for comment.