Clinical Trials at JJ Hospital under scrutiny: Panel Suggests Action Against Three Doctors including Former Dean
Mumbai: The five-member panel constituted by J J Hospital, which was probing the clinical drug trials conducted at the institute, submitted its final report to the Dean and the panel has suggested taking action against three doctors including a former dean, as per the Maharashtra Civil Services Rules.
Referring to this, the Dean of the institute Dr. Pallavi Saple told TOI that she had received the report and the same would be submitted to the State Medical Education Department authorities on Tuesday.
In the final report, the panel suggested carrying out a financial audit of the clinical trials to ascertain the extent of financial dealings over the past five years. Commenting on this, a senior State official told the Daily, "Since the inquiry started in June, we have received up to Rs 90 lakh as fees from doctors who conducted the trial. This institute fee is usually 10% of the payment received by the principal investigators."
The panel also wants institute-level guidelines for conducting clinical trials. Referring to this, the official added, "There are national guidelines, but we need local guidelines. For instance, the outfit conducting the trial, Parshwa Life Sciences, told the inquiry committee that it was unaware whom it had to pay the rent to and hence didn’t pay any until last week."
Medical Dialogues had earlier reported that the J J Hospital authorities came across a clinical trial set-up at the institute. The trial was being conducted at a 4,500 sq ft area on their premises. Besides, it was found that one of the honorary doctors of the institute was operating out of the pharmacology department where clinical trial drug trials were being carried out. The trial involved 14 people, who were not employed by the administration.
Also Read: Clinical Trial Scam: JJ Hospital Now Receives Rs 1 Crore Fees From Doctors
Earlier, the Dean of the Institute had constituted a five-member panel for investigating the clinical drug trials conducted since 2018. Apart from this, the panel had also been directed to investigate the role of a private firm, Parshwa Life Sciences (PLS), and a honorary physician of the institute.
It was also decided that the panel headed by the Head of the Microbiology Department, Dr. Ameeta Joshi, would also question a former-dean of the institute, who was accused of signing a memorandum of understanding (MoU) with PLS Ltd. for clinical drug trial. Before signing the MoU, the concerned authorities were not informed about it. The panel was asked to submit its report within a week.
After finding out violations of rules in the process of conducting clinical trials at Sir J J Group of Hospitals, the Dean of the Institute, Dr. Pallavi Saple also directed the five-member committee to streamline the process of clinical trials at the institute.
Previously, the panel interviewed the faculty members from all the departments who had carried out the clinical drug trials which were sponsored by pharma companies. The Faculties were asked to give in writing if the trials that they had conducted from 2015 involved PLS. Further, details regarding the total number of trials conducted, if there were any adverse effects etc. were also sought.
As per the latest media report by the Times of India, the panel has now submitted the final report and suggested to the Dean for taking action against three doctors including a former dean, as per the Maharashtra Civil Services Rules.
The report has named former dean Dr. Tayade for signing a memorandum of understanding with PLS to pay Rs 2 lakh rent for using three rooms in the pharmacology department of the hospital. According to the PWD rules, commercial rent should be charged from private organisations renting out space in government bodies.
Apart from the ex-dean, the former medical superintendent of St. George's Hospital, Dr. Khobragade has also been named by the panel for allegedly failing to carry out his duties as the coordinator for the whole clinical trials arrangements with PLS.
Along with Dr. Khobragade, an honorary professor from the medicine department Dr Gupta reportedly conducted the maximum number of trials. Referring to this, a State Official told TOI, "Dr Gupte turned up for the inquiry last week and paid the institute fees." Besides, a former head of the pharmacology department has also been named by the panel in the report for choosing PLS.
