MUMBAI-based MNC drug manufacturer Glenmark Pharmaceuticals has complained to the drug regulator that the government-funded research centre, Guru Govind Singh Hospital in Jamnagar (Gujarat), is indulging in unfair practices while conducting human trials.
The company discontinued the clinical trial for its lead asthma drug Oglemilast undertaken by the research centre in March this year after it found that the hospital was manipulating data, an official in the company, who didn't wish to be named, said. The US-based Omnicare Clinical Research chose Guru Govind Singh Hospital as one of the sites to conduct clinical study of Oglemilast on behalf of its client Glenmark.
The company has sought an immediate audit of the site by the Drug Controller General of India (DCGI), the official said. It also expressed suspicion about improper screening of the volunteers before enrolling them for the trial.
"Immediately upon suspecting fraudulent activity, Glenmark and Omnicare carried out appropriate for-cause audit and confirmed the fraud. This was immediately brought to the attention of the chairman of the ethics committee, who is also the hospital superintendent," a company spokesman said. While clinical trials at the Jamnagar site is stopped, it is being conducted at 27 other sites across the country.
Experts in pharmaceutical industry say that majority of trust hospitals and government hospitals in Gujarat are indulging in unethical trials. "For enrolling a poor patient, doctors are being paid commissions up to Rs 120, 000," Rajkot Cancer Society trustee Kishore P Ghiya said.
A health ministry official confirmed the development and said that the DCGI will soon initiate an audit of the hospital.
Oglemilast is a potential molecule of Glenmark Pharmaceutical. Glenmark through its wholly-owned swiss subsidiary Glenmark Pharmaceuticals SA has a collaborative agreement with Forest Labs for Oglemilast. As per the agreement, Forest Labs would develop register and commercialise the drug in the North American market, while Glenmark will retain commercialisation rights for the rest of the world.
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