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Glenmark Brings to the Notice of the Authorities Irregularities of the Clinical Investigator at its Jamnagar Site in Gujarat
Date:7/23/2009

n early April 09 and in June provided the DCGI with an update of its actions and findings at the site.

Dr Bhattacharya has been accused of fraudulent behaviour by the Hospital Superintendent in Jamnagar, and as a result Dr Bhattacharya has now been suspended from the Baroda Medical College (where he was transferred from Jamnagar) while the police complete their investigations regarding the full extent of potential fraud by Dr. Bhattacharya in all clinical trials he had been involved in with other CROs and pharmaceutical companies.

Glenmark and Omnicare remain wholly committed to ensuring the highest quality and care in all their clinical trials in keeping with international regulatory and safety standards, and remain fully committed to taking strict action for early identification and prevention of such fraudulent activities in future. Glenmark has already decided that it will not consider any data received from this site pertaining to the study. The Phase IIb study continues to progress as per plan at other sites across the country. Being a leading company in the area of drug discovery and development, Glenmark Pharmaceuticals Ltd conducts all its clinical trials to the highest internationally recognised regulatory standards as defined by the International Conference on Harmonisation of Good Clinical Practice (ICH-GCP) and to local Indian regulations as recognised in Schedule Y of the Drugs and Cosmetics Act. In addition, Glenmark conducts all clinical trials in accordance with the internationally recognised ethical principals laid down in the Declaration of Helsinki, and the local Indian ICMR Ethical Guidelines.


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SOURCE Glenmark Pharmaceuticals Ltd.
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