Glenmark suspends Ph II clinical trial at Indian site following alleged ‘irregularities’
According to an article from the Economic Times, inspectors from India’s Central Drugs Standard Control Organization (CDSCO) have been sent to investigate claims that several persons were “deceived” into participating in a clinical trial at a hospital in Jaipur, Rajasthan.
Per the article published yesterday, more than 15 people from a village in Rajasthan were allegedly brought to the Malpani Multispecialty Hospital in Jaipur “under the pretext that they would get work.” Social activist Vimal Toshniwal claims they were instead “given a tablet without informed consent,” according to the article.
The Economic Times named the alleged “tablet” as a pain medication currently under development by the Mumbai-India headquartered pharmaceutical company Glenmark Pharmaceuticals – which was granted permission to conduct the Phase IIb dose-ranging study in January 2018.
“Glenmark has been conducting clinical trials in India and around the world since many years. Patient safety and regulatory compliance are of utmost importance to us,” a company spokesperson told us in a statement responding to the allegations.
The Malpani Hospital in Jaipur is one of many sites at which Phase ll clinical trials for the company’s molecule GRC 27864 have been initiated, the spokesperson explained. “Malpani Hospital has enrolled only 3 patients in this trial and no adverse reactions have been reported so far,” they said.
Glenmark announced on January 16, 2018, that the Directorate General of Health Services, CDSCO, Government of India, had granted the company permission to conduct the study in 624 patients with osteoarthritis.
The Phase II study for GRC 27864 has since been initiated at 23 sites across India. The company spokesperson said no protocol-related issues have been faced at any of the sites. “For the trial at Malpani Hospital, Glenmark has in place all the necessary regulatory approvals,” they added.
“However, 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,” the spokesperson told us.
“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 safety of patients.”
