The clinical trial on human volunteers at Malpani Hospital in Jaipur on Tuesday took a new turn when Glenmark, the pharmaceutical company, whose drug was being tested suspended the trial and launched its own investigation into alleged ‘unethical practices’.
In a statement Glenmark said that “Malpani Hospital in Jaipur is one of the many sites that has recently initiated Phase ll clinical trial for Glenmark’s molecule GRC 27864on patients with moderate osteoarthritis pain. The company has decided to immediately investigate the matter and suspend the clinical trial at the site.”
Meanwhile, two committees set up one each by union health ministry and state health department to probe the matter have completed their primary investigation and if sources are to be believed, they have found irregularities at the hospital level. In view of irregularities discovered, Central Drugs Standard Control Organisation (CDSCO), the apex drug regulatory body in India, may send another probe team for an in-depth investigation.
“The probe panel from CDSCO returned to Delhi on Monday and submitted its report on Tuesday,” Ajay Phatak, Drug Controller-II told DNA. “The investigation team formed by state health department has also submitted its report to Director public health,which was forwarded to CDSCO,” he added.
“From the day one, owner and doctors at Malpani Hospital have been giving different statements. At first, they denied conducting any kind of clinical trial. Later, they admitted to the drug trial but added that it has been conducted only on three persons. Two of them, when contacted and reached by the probe team, denied being part of any trial and even denied visiting the hospital for this purpose. Phone number of the third person, as per the hospital records, remained out of reach,” Phatak said.
“From the day one, owner and doctors at Malpani Hospital have been giving different statements. At first, they denied conducting any kind of clinical trial. Later, they admitted to the drug trial but added that it has been conducted only on three persons. Two of them, when contacted and reached by the probe team, denied being part of any trial and even denied visiting the hospital for this purpose. Phone number of the third person, as per the hospital records, remained out of reach,” Phatak said.
Another team to probe
“During the probe of CDSCO team, it has been found that matter is connected to other parts of the state like Churu also. Since the issue is so massive, it is possible that a team would be send for further in-depth investigation,” Phatak said.
Hospital lied
According to Phatak, during the probe, it has been found that the hospital had received 38 packets of drugs for the trial but the team have found only 35packets at the hospital. The hospital administration failed to give satisfactory reply about three missing packets. Each packet contains 14 tablets.
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