The dozen of people has now come forward against Glenmark Pharmaceuticals and a Jaipur-based Multispecialty hospital claiming the duo tricked, inducted them into an ongoing clinical trial for the former’s pain medication, GRC 27864, without their knowledge.
These men were told they would be taken to a “medical camp,” where there would be some work, some remuneration, some alcohol and an opportunity to watch the IPL cricket match. On reaching the Malpani Multispeciality Hospital in Jaipur, where the medical camp and the money were supposed to be, they claimed that they were served dinner at the hospital and then went to sleep.
The next morning, the accusers told The Wire, a doctor by the name of Rahul Saini came and spoke to them. “We are going to give you some medicines. If you feel uncomfortable, do not worry as we are all doctors here…” He told them they would be given nine different tablets over the next nine days, and gave them one tablet to be taken that same morning (19 April). From here on, things got a little fuzzy for these men as they fell asleep and then woke up again after about a day. And that’s when they realized something had gone wrong– they were feeling drowsy and some said they are still in pain, days after they were given these tablets.
The trial aims to be conducted on 624 subjects. The trial is currently underway in 38 sites around the country, including two sites in Rajasthan, both in Jaipur, one of which is Malpani hospital. It is a randomized, double-blind, placebo-controlled phase 2 trial.
ANI reported that these drugs were meant for animal testing. But this is not likely as phase 2 trials are conducted on humans, not animals.
The hospital has denied the claims and allegations, as the persons in question were in fact told they could not participate in the trial because they were not eligible.
According to a GPL spokesperson, “In the wake of the event of media reports alleging irregularities at the hospital, the company has decided to immediately investigate the matter and suspend the clinical trial at the site.”
In an official company statement obtained by The Hindustan Times, the company says, “Glenmark has been conducting clinical trials in India and around the world for many years. Patient safety and regulatory compliance are of utmost importance to us. Malpani Hospital in Jaipur is one of the many sites that have recently initiated Phase ll clinical trial for Glenmark’s molecule GRC 27864 in patients with moderate osteoarthritis pain. Malpani Hospital has enrolled only three patients in this trial and no adverse reactions have been reported so far. The Phase II study for GRC 27864 has been initiated at 23 sites so far across India and we have not faced any protocol-related issues at any of the sites. For the trial at Malpani Hospital, Glenmark has in place all the necessary regulatory approvals. Glenmark will also fully support and cooperate with the regulatory authorities in any investigation on this trial. As a responsible organization, we will not compromise the safety of patients.”