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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

MUMBAI, July 23 /PRNewswire-FirstCall/ --

- A Police Complaint has Been Lodged by Hospital Authorities Citing Fraudulent Activity by the Clinical Investigator Dr. A Bhattacharya Working at the GG Hospital and the MP Shah Medical College

- Glenmark Not Only Acts as the Whistle-Blower but Also Discontinues its Clinical Study at the Mentioned Site

After receiving approval from the Drug Controller General of India(DCGI) for a multi-centre Phase IIb clinical study for its lead COPD/asthma molecule, Oglemilast, Glenmark Pharmaceuticals Limited contracted Omnicare Clinical Research(Omnicare), a leading international CRO to conduct this Phase II asthma study on its behalf. Appropriate preclinical and clinical evaluations were completed prior to initiating this phase IIb asthma study. Being a multi-centre clinical study, one of the sites chosen was Guru Gobind Hospital, Jamnagar, Gujarat. Dr. A Bhattacharya, who was at that time working with the hospital was the clinical investigator for this mentioned site.

After Dr. Bhattacharya provided all necessary approvals and completed documentation, the site was initiated at the end of 2008. During monitoring activities immediately after initiation of the site, Omnicare suspected fraudulent activity. Without delay, Glenmark along with Omnicare carried out the appropriate for-cause audit and confirmed the fraud. This was immediately brought to the attention of the Chairman of the Ethics Committee at the concerned Hospital. Omnicare along with Glenmark acted swiftly and closed the site in line with normal regulatory requirements, to ensure the appropriate care/safety of the patients was protected. It is important to confirm that no patients have been put at risk, and no further patients have been or will be recruited in the clinical study at Jamnagar. Glenmark also immediately formally notified the DCGI of the situation at Dr Bhattacharya's site i
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SOURCE Glenmark Pharmaceuticals Ltd.
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