Clinical Trials Put Volunteers’ Lives At Risk In Telangana

Hyderabad:The Central Drugs Standard Control Organisation (CDSCO) may have chosen not to provide information sought on serious adverse events (SAEs) or SAE related deaths in Hyderabad and Telangana for the past five years as sought in an RTI inquiry filed with the central government organisation. However, sources revealed that a troubling development last month may be a pointer to not all clinical trials going well in Hyderabad.

According to the sources, a ‘volunteer’ who was promised Rs 20,000 in return for participating in a clinical trial in Hyderabad — that was ostensibly being conducted using two Class I drugs for treating cardiac failure or serious cardiac related incidents — visited a government hospital this June and July, complaining of severe pain in the chest, and giddiness.

This person also revealed at the hospital that a fellow participant in the same trial had died a few days prior to his hospital visit after reporting similar complaints. In addition to the two drugs/combinations named by the person, the sources said that it was also informed by this participant that along with the two drugs, a powder mixed in water was also administered but no information was provided as to what this third material was.

The sources said the participant admitted to having signed an ‘informed consent’ form but wanted to withdraw from the trial as he was worried for his life after the death of a fellow participant. However, when this participant approached the CRO conducting the trial and reported his symptoms and sought help, this ‘volunteer’ was warned not to talk about a co-participant dying, and say nothing about the trial as the company had “all the information, address, Aadhaar number, and family details,” the sources said.

Instead of attending to the participant’s concerns as required by law, the CRO, the sources said, gave the trial participant `500 and was sent to a government hospital for treatment. “This person, who came with complaints of chest pain twice, once in June and again in July, was very worried that the company doing the trial would follow through with its threat. Though we had an attendant accompany the person to get the tests done, the participant slipped away and never returned. All efforts to reach the person subsequently on the provided phone number proved futile,” the sources said.

Such was probably the fear the participant had that his family may have to face the consequences of him going public about the death of a fellow participant, as reported by this person, that even the address provided to the hospital by the person proved to be wrong. Though the house exists, none with the name the participant gave the hospital lives at that address, a visit to the address revealed.

Neither the CRO — based in northwest region of Hyderabad, and one of the more than one hundred CROs in the city — that this person is reportedly undergoing a trial with, nor the drugs that the person reported was administered, figure anywhere in the online Central Trial Registry of India (CTRI), which is mandatory for any kind of a clinical trial.

“Even if it is just a simple comparative study trial and even if such a trial is using already proven drugs, it must be listed with CTRI. Irrespective of what kind of a trial it is, it must be listed,” an authoritative source experienced in clinical trial regulatory mechanisms said.

“If what this person who went to a government hospital said is true, it is a very serious violation of clinical trial rules even if the person signed an informed consent as such consents make it mandatory for the CRO itself to provide immediate and any subsequent medical care required if a participant reports any symptoms,” this source said.

When contacted the regional office of the CDSCO was not willing to take any questions on the subject declaring that it was not in a position to do so as all inquiries related to any clinical trial, or related subjects can only be responded to by its central office in New Delhi.

Serious Adverse Events (injury) all over India*

Year – Number

2021 – 1,412

2022 – 1,786

2023 – 1,627

2024 – 1,359

2025 (till July) – 1,005

Total: 7,189

Reported SAE (death) all over India*

Year - Deaths

2021 – 409

2022 – 341

2023 – 376

2024 – 347

2025 (till July) – 232

Total: 1,705

Compensation provided to 68 ‘subject’ as per law

Data from RTI inquiry response from CDSCO

Information sought in RTI inquiry for data for Hyderabad/Telangana. The RTI query was “How many adverse events have been reported in the ongoing clinical trials in Hyderabad, and in entire Telangana, year wise in the past five years, company wise, drug/pharmaceutical preparation/medicine wise.”