Navigation Links
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 in 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.


'/>"/>
SOURCE Glenmark Pharmaceuticals Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. HealthPROSe Brings Creative, Strategic Thinking to Health Blogosphere
2. A Bundle of Joy Brings a Bundle of Questions - Life123.com Delivers the Answers!
3. As Fire Ants Continue to Proliferate, Hospital-Proven Burn Anesthetic Brings Instant Relief for Bites, Stings
4. Materials and Processes for Medical Devices Event Brings Clinicians, Engineers, Designers Together
5. USAID Brings White House Service Initiative to Baltimore
6. Opening Day of Fi Asia-China 2009 Brings the Food Ingredients Industry to Shanghai
7. Brio Active Brings Whole Body Vibration Fitness to Cherry Hills Village
8. White House Health Reform Stakeholder Discussion Brings Palliative Care to the Table
9. Best and Brightest Forum on Medical Innovation Brings Senator Arlen Specter, U.S. Representative Anna Eshoo, and Innovation Leaders Together in Washington, D.C., This Week
10. "Alliance between Europe Cosmetiques and Probiox brings new oxydative stress profiling technologies to North America"
11. St. Louis Firm Brings Medicare Risk Adjustment to iPhone
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2017)... ... May 26, 2017 , ... Mediaplanet is proud to announce the ... USA Today, which will educate readers on how to take care of all aspects ... focus is placed on melanoma. Dancing with the Stars professional, Witney Carson, shares her ...
(Date:5/26/2017)... ... May 26, 2017 , ... Somnoware, a leading provider of ... with its Somnoware Sleep Device Interface (SDI). Somnoware SDI is a sleep device ... this platform, initializing devices and importing studies are just one-click operations. This plugin ...
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... After raising ... Antzy Top gadget will continue to be available at a discounted crowdfunding price on ... with stress wherever they are, I also wanted to bring a fidget toy to ...
(Date:5/26/2017)... ... May 26, 2017 , ... “When the Stars Lead Home”: a poignant ... of published author Laura Weigel Douglas, an avid reader who lives in the Pacific ... sometimes feels like Green Hills Adventure Camp. She couldn’t be more grateful. , Twelve-year ...
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... Water damage ... Lee, New Jersey School District had left education officials with a number of critical ... replacement of the flooring had to be accomplished with little or no disruption to ...
Breaking Medicine News(10 mins):
(Date:5/9/2017)... , May 9, 2017  Oramed Pharmaceuticals Inc. ... a clinical-stage pharmaceutical company focused on the development ... the Canadian Intellectual Property Office has granted Oramed ... Administration of Exenatide". The patent covers Oramed,s invention ... GLP-1 is an incretin hormone that stimulates ...
(Date:5/6/2017)... Texas , May 5, 2017   Provista , ... with more than 200,000 customers, today announced Jim Cunniff ... a wealth of executive and business experience to Provista, including ... compounding pharmacy in California . He assumed ... "Jim is a great fit for Provista," says ...
(Date:5/4/2017)... 2017  A recent study published in the ... light as a means of disinfection anesthesia workstations ... bioburden on anesthesia workstations. In the study, UVC ... medical equipment surfaces contaminated with three (3) organisms ... study further validates the body of literature supporting ...
Breaking Medicine Technology: