The hospital has claimed the allegations are false, as the persons in question were in fact told they could not participate in the trial because they were not eligible.
Two inspectors from CDSCO have been sent to investigate these allegations and ensure that proper clinical trial protocol was followed at the hospital, confirmed senior government officials on condition of anonymity. It is not clear how long this investigation will take.
Meanwhile, the Rajasthan Department of Medical, Health and Family Welfare is also conducting a separate investigation into the allegations and this is expected to take at least three days, Dr VK Mathur, public health director at the department, told ET.
Over 15 persons from a village in Rajasthan were brought to Malpani Multispecialty Hospital in Jaipur under the pretext that they would get work, but were given a tablet without informed consent, alleged social activist Vimal Toshniwal.
Malpani, along with 21 other hospitals in India, was authorised in December 2017 to conduct phase II clinical trials for an osteoarthritis pain medication developed by Glenmark Pharma, according to a document by CDSCO that ET has viewed.
“The hospital needed some people for a medical trial, so someone in the village brought these men saying they would get work. They didn’t tell them what the real story was,” alleged Toshniwal, who has been aiding the persons that claim to have been involved in the trial.
Malpani Multispecialty director Dr NK Malpani has denied the allegations against the hospital. Only three persons are currently enrolled in this trial at the hospital and it has been looking for more patients specifically suffering from osteoarthritis to participate, he said.
As many as 25 people approached the hospital for the Glenmark trial on April 19, but no medication was given to them as they had arrived too late in the day to be screened, he claimed.
“Next morning, our chief investigator found that none of these patients were eligible for the trial,” Dr Malpani told ET.
A criteria used to determine patients were fit for this trial was whether they were between 40-70 years of age, but none of the persons making the allegations were above 35 years old, he claimed.
“No medicine was given to them and nobody got ill…We also never treated a single patient for any adverse reactions (to this medication). If they were ill, they would have had to go somewhere (for treatment),” he said. “These allegations were fabricated…and just to extract money,” he added.
Multiple phone calls and a message to Dr Rajiv Gupta, the investigator in charge of conducting the trial at Malpani, remained unanswered on Sunday.
ET is awaiting a response to queries sent to Glenmark about the allegations.
A release by the company dated January 15 shows it had received approval to conduct a Phase IIb study to evaluate the safety and efficacy of the drug, currently labeled ‘GRC 27864’ in patients with moderate osteoarthritic pain. The study is to be conducted in a total of 624 patients in India with osteoarthritis of the knee and hip, according to the release.
“DCGI granted permission to conduct the Phase II study based on the results of three Phase I studies conducted in healthy adult and elderly volunteers,” the release stated.