Pharma company suspends clinical trial at Jaipur hospital
Drug controller-II, Jaipur, has said that a second DCGI team will probe the matter further.jaipur Updated: Apr 24, 2018 22:34 IST
After reports of “irregularities”, Glenmark Pharmaceuticals Limited (GPL) has suspended clinical trials at the Malpani Hospital in Jaipur. The hospital had allegedly conducted the trial on 17 people from Churu district.
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.”
The company in its statement said, “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 organisation, we will not compromise the safety of patients.” HT has the copy of the statement.
A group of 21 people from Bidasar area in Churu district was brought to Malpani Hospital on Wednesday on the pretext of working as volunteers on a daily wage (between Rs500 and Rs 1000). On Thursday, when the drug was given to them, four of the 21 refused to take the medicine and went back to the village, while the remaining 17 were allegedly given an oesteoarthritis drug for trial.
Nine out of 17 victims of the clinical trial on Friday came to the media and alleged that they were given drugs for trial, after which they suffered from headache, nausea, pain in limbs, dizziness etc.
After reports were published in the media, the state government formed a four-member committee on Saturday to investigate the matter. The team checked the hospital records for five hours and found that three medicine packets, out of 38, received from the company for trial were missing. The hospital administration could not give a satisfactory reply.
On Sunday, a four-member team from the Drug Control General of India (DCGI) of Ministry of Health and Family Welfare from Delhi arrived in Jaipur. The team refused to divulge details and said that the probe is on and will take time.
Meanwhile, on Tuesday, Ajay Phatak, drug controller-II, Jaipur said, “The team has submitted its report to the director public health, which has been sent to DCGI. The DGCI team left Jaipur on Tuesday and submitted its report to the central government.”
He said prima facie there are irregularities at the hospital conducting the clinical trial. Initially, they did not give a satisfactory reply about the missing three packets of the drug and later said that the three packets have been used for the clinical trial. The hospital administration initially refused to accept that patients from Churu were admitted to the hospital, later they admitted that 21 people were admitted. “Changing statements have created suspicion on the hospital,” Phatak added.
He said the team also tried to contact the three patients who were administered the medicine. Two patients refused to accept that they had taken the medicine, while the third patient was not reachable by phone.
Phatak said that another team from DCGI will also probe the matter further.