17/18 March 2021
On 16 December 2016, the European Medicines Agency (EMA) once again published information on its website on considerable deficiencies found in bioequivalence studies that were conducted at study sites in India.
During GCP inspections conducted by regulatory authorities at two Indian sites, serious violations (concerning documentation and data integrity among others) were found and critical observations in the quality management system were made.
The results of the inspections in February 2016 conducted jointly by Dutch and Austrian regulatory authorities at the two Indian study sites, Micro Therapeutic Research Labs in Chennai, Tamil Nadu and Micro Therapeutic Research Labs in Coimbatore, Tamil Nadu, affect the reliability of the data provided by these study sites during June 2012 and June 2016.
As a consequence, the results of the associated bioequivalence studies conducted during this time are questionable. This will have a direct effect on the associated medicines authorized in Europe. Several national medicines regulatory agencies (Austria, Bulgaria, Croatia, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Latvia, the Netherlands, Norway, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom) have requested EMA to assess the impact of these findings on the benefits and risks of medicines authorized in the EU. EMA has also been requested to determine if any action is necessary to protect public health in view of medicinal products that have already been authorized or are currently being evaluated for authorization and which use study data from these sites.
It is expected that the national medicines regulatory agencies will again suspend approvals related to clinical investigations and in particular bioequivalence studies conducted at these study sites in India. The companies concerned should check their data now and, if necessary, take appropriate measures sufficiently early.
Further information is available under Start of a review concerning the conduct of studies at Micro Therapeutic Research Labs, India on the EMA Website.