Last Updated on May 21, 2025 by The Health Master
Clinical Trials
This comes on the heels of alleged illegal clinical trials as a huge concern, as the Central Drugs Standard Control Organisation (CDSCO) regional office team visited VS Hospital in Ahmedabad this week.
The CDSCO team made their visit to the site. They apparently also visited the Ahmedabad Municipal Corporation (AMC), meaning the two teams are working in tandem to gather information either to support or refute these claims of illegal clinical trials.
58 Clinical Trials
Currently, reports suggest that 58 alleged illegal clinical trials have been operated at VS Hospital without the necessary permissions.
Sources say that the CDSCO officials came and spoke to a senior person at the AMC, with whom they relayed pertinent information regarding the investigation.
CDSCO Steps in
The CDSCO stepped in after the involvement of the Supreme Court.
The NGO Swasthya Adhikar Manch (SAM) submitted a petition bringing the wrongful conduct at VS Hospital to the attention of not only the court but also the public.
Thus, with the Supreme Court’s involvement, it was only proper that the CDSCO conduct what appears to be an investigation of necessity.
AMC Sends Report
To ensure those at fault would be faulted, an AMC official spoke to the media, stating, “We supplied a copy of our inquiry committee report to the CDSCO, which includes the action taken by the civic body, the details of the financial transactions, and the action taken against the doctors who were involved in the alleged illegal trials.”
Thus, through the inquiry report, it’s clear that the CDSCO was sent enough information to suggest that there was more to the financial misgivings than met the eye and that the AMC went out of its way to attempt to amend such misconduct through extreme penalties.
Scope of the CDSCO Investigation
The CDSCO’s investigation will include these key aspects of the clinical trials at VS Hospital, as an AMC official clarified the elements of review in a bid to reassure that trial patient rights and safety were on the line.
Elements of review by the CDSCO inspection team:
- Informed consent forms and process: whether they sufficiently informed subjects of all risks and benefits and whether proper consent was given. This is important for patient rights in clinical research.
- Rights and Safety of Trial Subjects
- Ethical Review Procedures
Furthermore, the CDSCO will examine the rationale behind a private ethics committee located away from the VS Hospital campus, whereas the adjacent SVP Hospital had its own.
“Another crucial aspect of the investigation is the choice of a private ethics committee outside the VS Hospital campus, while neighboring SVP Hospital had an ethics committee in place,” said the AMC official. The justification for this and what it might mean will be assessed by the CDSCO as a red flag.
The point of the CDSCO is to stamp out any potential regulatory oversights as it relates to any clinical trial under its purview.
Thus, in addition, “The CDSCO will also examine study protocols, Case Report Forms (CRFs), and source documents to ensure trial activities align rigorously with approved protocols and established regulatory standards.”
Finally, the inspection by the CDSCO will involve data integrity and compliance with established protocols.
“The CDSCO determines whether there was compliance with Good Clinical Practices guidelines and the New Drugs and Clinical Trials Rules, 2019.
Also, it assesses sponsor-submitted data versus site source documents for data integrity, especially on post-trial inspections or for-cause inspections.”
Therefore, this comprehensiveness seeks to find out if what was attempted to be done with these illegal clinical trials had any aspects that were unethical or an illegitimate following of appropriate measures.
Why was VS Hospital investigated?
A Supreme Court intervention based on a petition filed by NGO Swasthya Adhikar Manch (SAM) probing adjustments with clinical trial activities.
What does the CDSCO want to know?
The CDSCO wants to know whether illegal clinical trials occurred at VS Hospital based upon informed consent, patient safety, ethical guidance, study protocols, data integrity, and Good Clinical Practice.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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