As regulatory authorities in India move to tighten up oversight of the country’s fast-growing clinical research sector, local company Glenmark Pharmaceuticals has announced the closure of a clinical trial site in Jamnagar, Gujarat state, citing fraudulent activities.
Glenmark started using Guru Gobind Hospital in Jamnagar at the end of last year as one of the sites for a Phase IIb clinical trial of Oglemilast (GRC 3886), its lead compound for asthma/chronic obstructive pulmonary disorder. The multi-centre trial is being conducted for Glenmark by US-based contract research organisation (CRO) Omnicare Clinical Research.
The accusation of fraud is against Dr A. Bhattacharya, who at the time was the clinical investigator for the trial at Guru Gobind Hospital. He was subsequently transferred to Baroda Medical Medical College. Glenmark said Bhattacharya had now been suspended from that position while police investigated the full extent of potential fraud committed by the doctor in studies for other CROs and pharmaceutical companies.
According to Glenmark, signs of irregularities emerged during monitoring of the Guru Gobind site immediately after it joined the trial. Fraud was confirmed in a for-cause audit by the company and Omnicare, which brought the issue to the attention of the hospital’s ethics committee.
“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,” Glenmark reported, adding: “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.”
The company also formally notified the Drugs Controller General of India about the situation in early April and updated the regulatory authority on its actions and findings at the site in June.
Glenmark said it would not be considering any of the data generated from Guru Gobind Hospital, while the Phase II trial of Oglemilast “continues to progress as per plan at other sites across the country”.