A hospital in India has been accused of misleading over a dozen people into joining a clinical trial of a Glenmark Pharmaceuticals painkiller without their consent, drawing an investigation from the country’s drug regulators, according to an article by The Economic Times.
Both the Malpani Multispecialty Hospital in Jaipur and Glenmark deny the allegations. A Glenmark spokesperson told FierceCRO the company has decided to immediately suspend trial operations at the hospital site and will fully cooperate with authorities. The recently initiated phase 2b study of GRC 27864 in moderate osteoarthritis pain has been initiated at 23 sites across India.
India’s Central Drugs Standard Control Organization has dispatched two inspectors to determine any violations in clinical trial procedures and regulations, according to The Economic Times. In addition, the local state health and welfare department has begun conducting its own investigation.
According to the reported allegations, several people from a nearby village were told they would find work at the hospital, but were instead given medication. The Times of India also reported missing packets of drugs for the study, and 17 laborers were later sent to a government-run health center complaining of uneasiness and headache.
The hospital, meanwhile, said it turned the people away after they were found to be too young to participate in the trial.
“Malpani Hospital has enrolled only three patients in this trial and no adverse reactions have been reported so far,” said the Glenmark spokesperson.
According to a previous company release (PDF), Glenmark was granted permission for the placebo-controlled study by the CDSCO in January, with plans to enroll 624 patients with osteoarthritis of the knee and hip for 12 weeks and evaluate three doses compared to placebo.