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Drugmaker Glenmark will respond later this week to a showcause notice from the Central Drugs Standard Control Organisation involving a clinical trial done at Jaipur's Malpani Multispeciality Hospital.
The hospital is one of 23 sites where Glenmark had initiated Phase II clinical trials on its drug molecule GRC 27864 for osteoarthritis. The safety and efficacy of this drug candidate was being tested on patients with moderate osteoarthritis.
However, Glenmark and Malpani Hospital's principal investigator now face CDSCO scrutiny for reasons including the falsification of data. A worrisome development because many local and multinational drug companies are believed to be conducting clinical trials at this hospital.
The Drug Controller General of India, Eswara Reddy, told BusinessLine that the other trials done at Malpani Hospital would also now be scrutinised by the regulator. An unsettling development for the domestic clinical trial industry that was just beginning to find its feet in a regulatory regime that had become more stringent under the Supreme Court's watch.
In fact, the allegations of irregularities at Malpani Hospital bring back ghosts from the past in terms of patient recruitment and consent, fudged data, who takes responsibility, and the critical role of the ethics committee.
In 2013, following the uproar over incidents of death and questionable practices involving the clinical trial industry, the Government had set about the process of tightening the regulatory framework. Suggestions were made on accrediting ethics committees that scrutinised every trial, hospital sites, principle investigators, etc.
But as the Jaipur hospital incident reveals, years on, governance continues to slip through the cracks.
Jaipur backstory
Trouble began brewing over Glenmark's trial at the Malpani Hospital when reports emerged last month of 15-odd farmers complaining of drowsiness after they were allegedly put on a drug trial without consent. The CDSCO subsequently began investigating this alleged transgression.
Glenmark says it suspended the trial at the hospital when the alleged irregularity came to light. Preliminary CDSCO investigations revealed that details of the initial three patients on the trial were also inaccurate, a responsibility laid at the principal investigator's doorstep. Responding to why Glenmark's early warning system did not catch the alleged malpractice at the hospital, an industry source explained that companies do regularly audit their sites. But a daily check was not possible, which is why a principal investigator (doctor who conducts the trial) and the hospital ethics committee are in place.
The company also explains that the said trial had all the required regulatory approvals. In fact, Malpani Hospital is a “CDSCO-approved” site where several companies, including multinationals, have conducted trials over several years, it said.
On its part, the hospital has refuted reports of malpractice indicating that some disgruntled individuals who were not recruited into the trials may be trying to “frame” the hospital. But, if CDSCO's investigations do indeed unearth malpractice at the hospital or by its doctors, it would open a Pandora's box by putting a question mark on the many trials done there by other companies.
Commenting on reports that the hospital was a Government “recognised” centre for clinical trials since 2009, DCGI Reddy clarified that the Government never approves a site, only a trial done at a particular hospital if all the protocols are in place.
Ethics committee responsibility
The DCGI agrees that the Jaipur incident raises questions on the supervision done by the Institutional Ethics Committee. People on ethics committees need to be trained on monitoring clinical trials better, he said.
The ethics committee has a key role in protecting the patient's interest, among other things, explains Dr Arun Bhatt, an expert on clinical trial issues. While the rules governing clinical trials have been strengthened, the need now is to improve the quality of trials through accreditation of trial sites, ethics committees and principal investigators, he suggests, on the governance loopholes that still need to be fixed.
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