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DCGI seeks response from Glenmark on clinical trial deficiencies by May 12

Indian drug regulator found deficiencies in clinical trial protocols including an alleged falsification of patient enrollment data at Malpani Multispecialty Hospital in Jaipur, Rajasthan – in connection to a clinical trial of company’s osteoarthritis pain drug (GRC 27864) tested on patients as part of phase-2 trial.

Drug maker Glenmark Pharma will have to respond by May 12 on a show-cause notice issued by Indian drug regulator that found deficiencies in its clinical trial protocols.
The deficiencies include an alleged falsification of patient enrollment data at Malpani Multispecialty Hospital in Jaipur– in connection with phase two trial of company’s osteoarthritis pain drug (GRC 27864) tested on patients.
Glenmark was also pulled up by the Office of Drug Controller General of India (DCGI) for inadequate monitoring of the trial at the site,” S Eswara Reddy of DCGI said in the notice.
“You as a sponsor of the clinical trial have failed to monitor the clinical trial activities at the site and take remedial measures to ensure that clinical trial is conducted in accordance with the Drugs and Cosmetics Act,1940 and Rules,1945, OCP Guidelines, Schedule Y and other applicable regulations,” said the  DCGI in the notice on May 2.
DCGI issued notices to both Glenmark – the sponsor of the trial and Dr Rajiv Gupta, the Principal Investigator who is administering the trial, on May 2 and asked them to respond within 10 days of receipt of the notice.
Moneycontrol has seen copies of the two notices.
Glenmark had suspended the clinical trial at Malpani Hospital on April 22.
Onus on Malpani Hospital
The company has put the onus on Malpani Hospital for data discrepancies in informed consent form (ICF) and other deviations of clinical trial protocols.
The company said trials of the same drug are progressing as per the plan in other clinical sites.
“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,” the company said in a statement.
Glenmark added that Malpani Hospital is a CDSCO-approved site for clinical trials and it has been conducting trials for many companies, including multinationals, over the past several years.
“As soon as we became aware of the alleged irregularities at Malpani Hospital, we immediately suspended the trial at the site in the interest of patient safety. Further we would like to state that we have all the requisite approvals in place for the trial at the site and have already submitted all supporting documents of our approvals to the regulator,” the statement added.
The DCGI swung into action after media reports emerged about a group of men from Rajasthan’s Churu district filed a complaint alleging that they had been duped into participating in a clinical trial at the Malpani hospital. The men alleged of falling unconscious and woke up many hours later and have been feeling pain in their body since.
The phone numbers and addresses provided by the three clinical trial subjects in the informed consent forms (ICF) related to the drug were found to be falsified. The drug inspectors also found the basic infrastructure lacking at the Malpani trial site including lack of ventilation, air-conditioning, washroom, bed spacing, among others. The DCGI also found non-compliance with respect to patient enrolment process.
Malpani Hospital, however, said that around 25 persons reported for the trial, but were found unsuitable as they were below the age of 40. The hospital said it had asked them to go back and gave each person Rs 500 as travelling expense.
Sloppy implementation
The DCGI notices have once again put the spotlight on sloppy implementation of rules and protocols by certain investigators, clinical trial sites and those sponsoring them.
Clinical trials are a sensitive subject globally and more so in India, where the healthcare activists allege that there is a danger of poor and vulnerable be used as guinea pigs for the lure of money.
The clinical trial industry is steadily recovering from the disruption caused in 2013– when the government under pressure from courts, health activists and Parliament followed by series of deaths allegedly linking to clinical trials brought draconian changes to ensure patient safety and data integrity.
The forced many clinical research organizations (CROs) to shut shop in India, also dashing the hopes of any potential new drug from India.
According to IQVIA – less than 1.4 percent of global clinical trials are carried out in India with 17 percent share of global population and huge disease burden.
Understanding the complexities of the industry – the government has started to relax the rules by simplifying compensation guidelines and reducing the average timelines for approvals from two years earlier to 6-7 months.
“This is a clear case of data integrity, it clouds the credibility of the clinical trial itself,” said an executive of a CRO – who didn’t want to be named.
“This also points out to lack of oversight by the regulator over clinical trial sites,” the above person said.