Bayer response regarding concerns over its clinical trials in India
It is our objective to make new drugs available to patients worldwide, if possible, and for this reason, clinical studies are also conducted in India...In addition, the requirements by regulatory authorities often demand that studies are conducted locally in those countries in which approval is to be sought. All adverse effects are recorded and reported by the trial physician in clinical studies, regardless of whether or not a connection exists to the drug. Bayer adheres to local regulations in providing information on compensation and claims in the information provided to the patient prior to enrolment into clinical trials. Our study protocols are aligned with the responsible authorities and approved by the respective Ethics Committees.