New Delhi: Glenmark Pharmaceuticals Ltd is under regulatory scrutiny for alleged misconduct in carrying out clinical trials recently in Jaipur, two people in the know said.
The Central Drugs Standard Control Organisation (CDSCO) has allegedly found that fake identities were used in clinical trials, as well as evidence of substantial departures from good clinical practice (GCP), in what could be the latest blow to India’s drug-testing industry, which has run into a series of problems with international regulators in recent years.
The alleged misconduct on the part of the company has triggered a tough response from India’s apex drug regulatory authority, which has sent a show cause notice to the company for failing to ensure that clinical trial was conducted in accordance with the Drug and Cosmetics Act, 1940 and Rules 1945, GCP guidelines. The regulatory body has sought an explanation about the alleged irregularities within 10 days. Glenmark has, however, denied any wrongdoing.
The company came under the scanner following reports that several people were deceived into participating in an ongoing trial for pain medication to treat osteoarthritis at Malpani Multispeciality Hospital in Jaipur. A total of 38 kits were supplied by the company, of which only three were issued to the enrolled patients on 6 April. Glenmark has suspended the trials at the site.
CDSCO, which had initiated the inquiry and sent a team from its head office on 22 April to the site, found inadequate and inconsistent patient identification. According to the investigations, the enrolment of subjects was “falsified” and “cannot be relied upon”.
The team also found that out of three patients mentioned in the informed consent form (ICF), two were related to each other and did not visit the hospital in the last six months. “The team traced the address of the subjects and observed that the enrolled subjects mentioned in the ICFs were spouses. They said they had not visited Malpani multi-specialty hospital in the last six months,” said the report. Mint has reviewed the report and the notice.
The third person could not be traced by the investigating team.
The investigating team also raised concerns over non compliance with good clinical practice.
“It was found that the infrastructure provided for the clinical hall was not adequate as there was no ventilation, no AC, no washroom, not enough space between beds. The method of patient accrual to continue the trails was neither reviewed by, nor approved by, the ethics committee and hence not in accordance with the GCP guidelines and applicable regulations. Therefore, you are asked to show cause within 10 days of receipt of this notice,” it said.
The Drug Controller General of India Dr S. Eswara Reddy in his notice sent to the company has also held the company liable for failing to “monitor the clinical trial activities” and take “remedial” measures to ensure that clinical trial was conducted in accordance with the D&C Act”
A show cause notice has also been sent to the investigator.
When contacted, Glenmark said due diligence was maintained by the company. “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. The Malpani Hospital in Jaipur is one of the many sites that had recently initiated Phase II clinical trial for Glenmark’s molecule GRC 27864 in patients with moderate osteoarthritis pain.
“Malpani Hospital is a CDSCO-approved site for clinical trials and it has been conducting trials for many companies, including multinationals, for several years. As soon as we became aware of the alleged irregularities at Malpani Hospital, we suspended the trial at the site in the interest of patient safety. Further, we have all the requisite approvals in place for the trial at the site and have submitted all supporting documents of our approvals to the regulator,” said the Glenmark spokesperson.