Clinical Trial Scam: JJ Hospital Now Receives Rs 1 Crore Fees From Doctors
After the authorities initiated an investigation and around 30 doctors who conducted trials without proper paperwork or permissions from their departmental heads are now depositing the money that they should have paid before the commencement of the trial.
Mumbai: Around three weeks after the authorities of Sir J J Hospital found out violations of rules in the process of conducting clinical trials at the institute without paying any rent, the bank account meant to collect fees from the trials has now received deposits between Rs 60 lakh to Rs 1 crore.
Even though clinical trial rules make it mandatory for a doctor acting as the principal investigator of a pharma company to pay fees to the hospital, this rule was not followed at JJ Hospital.
However, after the authorities initiated an investigation and around 30 doctors who conducted trials without proper paperwork or permissions from their departmental heads are now depositing the money that they should have paid before the commencement of the trial.
Referring to the rules, a senior state official told TOI, "As per the country's clinical trial rules, a hospital has to be paid a sum by the doctor designated as principal investigator by the pharmaceutical company conducting the trial."
Around three weeks ago, the hospital authorities came across a clinical trial set-up at the institute. The trial was being conducted at a 4,500sq ft area on their premises. Besides, one of the honorary doctors of the institute was found to be operating out of the pharmacology department where clinical drug trials were being carried out and it involved 14 people, who were not employed by the administration.
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.
As per the latest media report by Hindustan Times, around two weeks ago, 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 drug effects etc. were also sought.
The Daily mentioned that PLS officials were also called for questioning. Commenting on this, a senior official at the hospital had told HT, “It was found that in some cases JJ doctors who did the trials were not paid. The committee is checking if the patients involved in the trials got the incentives mentioned in the contract.”
In the preliminary inquiry, it was revealed that the pharma company PLS had signed a MoU with former Dean Dr. Tayade back in the year 2018. Since then the company had been running a lab in the pharmacology department with 14 people and the honorary physician Dr. Gupta. Stage 3 and Stage 4 clinical drug trials involving branches of medicine, orthopaedic, ENT, dermatology, surgery, psychiatry, paedistric etc. were being conducted by the lab, they added.
Referring to this, another official had informed, “It has been found that the process of clinical trial is a mess that needs to be streamlined. It is observed that the ethics committee after giving permission for the trial has never checked if the patients have received incentives.” The official further informed that the committee will also examine the process that is followed in other medical colleges.
An official told the Free Press Journal, “Through a preliminary investigation it was learnt that Dr Tayade had signed an MoU in 2018 under which he had finalised that the PLS will give a rent of Rs2 lakh to the institution, but till date not a single rupee has been received. Moreover, the dean alone does not have power to sign such an MoU as they have to inform the Directorate of Medical Education and Research and seek permission from higher-ups. A show-cause notice has been sent to Dr Tayade and he will also be called for questioning.”
Meanwhile, the name of the honorary physician Dr. Gupta also cropped up in the recent investigations done by the Enforcement Directorate (ED) into the alleged Covid centres' scam. ED sources informed FPJ that Dr. Gupta allegedly monitored the health-technical aspects of the firm which managed these centres. Now, it needs to be probed if the PLS and the Lifeline Hospital Management Services provided manpower to the Covid treatment facilities.
Referring to the issue, the Dean of JJ Hospital, Dr. Pallavi Saple informed that there are many questions that need to be answered by the former dean Dr. Tayade and Dr Gupta who conducted the stage 3 and stage 4 clinical trials. The probe is also being conducted against the 14 people who were working in the pharmacology department where the clinical trials were being conducted.
There is only one ethics committee at J J Hospital. When a doctor wants to conduct a clinical drug trial, he/she needs to submit a proposal to the ethics committee consisting of a lawyer, a social worker, and a faculty member of another medical college.
In the proposal, the doctors are required to include the details about the approvals of the drug, the money involved in the trial, and about the sponsor. Before the commencement of the trial, a contract is signed. However, since the year 2020, apart from the approval from the ethics committee, permission from the State Government is also required.
In this regard, an official from the institute had earlier told HT, “The five-member panel is checking if the clinical drug trials conducted after 2020 had the government permission and whether the same was checked by the ethics committee.”
Times of India adds that the five-member panel, led by vice-dean Dr Ameeta Joshi is now unearthing newer facts about the clinical trial scam. It has been revealed that the pharma company Parshwa Health Sciences most probably started operating in JJ Hospital around three years ago, even before officially signing the rental agreement in 2018.
Commenting on this, a doctor claimed that the hospital possibly lost around Rs 4-6 crore in rent alone as the private firm got a highly subsidised rate. "This doesn't include the bills for electricity and amenities," he added.
The Daily adds that the probe has revealed that apart from the names of various hospital doctors as the principal investigator, all the trials also named a former medical superintendent of St George's Hospital, J J Hospital's sister institute. Referring to this, the official mentioned, "It was his responsibility to oversee the disbursement of funds and ensure rules were followed."
Meanwhile, the committee has submitted a provisional report to the Dean of J J Hospital Dr. Pallavi Saple. However, the panel is still interviewing doctors for understanding the extent of the scam.
While commenting on this, a senior doctor from the hospital told the Daily, "It is a mess of broken rules and financial irregularities." Another doctor mentioned, "JJ Hospital is a respected name and pharmaceutical companies would benefit by mentioning its name in the trial, but we are not sure about the calibre of the research."
In its report, the committee has stated that leasing the premises to a private firm is against the rules of the State Government. In this context, referring to the 2018 deal with the private firm Parshwa, an official of the state department of medical education and research, said, "The premises could only have been rented to the private firm at the commercial rate prevalent in Byculla at that time."
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