According to an interim report filed by an investigation committee constituted by Municipal Commissioner of Ahmedabad, around 58 national and international pharmaceutical companies have conducted clinical trials
With the shadow of alleged unethical clinical trials falling on doctors and pharmaceutical companies, the Swasthya Adhikar Manch (SAM) has written to the Union Health Secretary and the Drug Controller General of India urging a probe into reports involving Gujarat’s VS Hospital.
“According to an interim report filed by an investigation committee constituted by Municipal Commissioner of Ahmedabad, around 58 national and international pharmaceutical companies have conducted clinical trials on around 500 patients at the hospital since 2021,” the letter said. Citing media reports, the letter quoted Deputy Municipal Commissioner, Bharat Parmar as saying – “No ethical committee was established according to National Medical Commission and Drug Controller of India regulations during the tenure of the then Superintendent.”
“Despite the clear orders and directions of the Supreme Court in the case of unethical clinical trials, it is shocking that clinical trials were approved in the VS Hospital of Gujarat without a registered ethics committee. This is a violation of the Drug and Clinical Trials Rules 2019,” said SAM, a non governmental organisation.
SAM is presently in the Supreme Court, having raised the issue of unethical clinical trials over a decade ago. It has also written to top administrative officials in Gujarat, including the Chief Secretary and the Principal Secretary (Health) mentioning a list of hospitals and details of the ethics committee in the State, along with the number of trials conducted – seeking a detailed investigation and action, it said.
“It is a serious matter of violation of the guidelines, acts, rules, and orders of the Supreme Court of India in case no WP (civil) 33/2012. The SC gave detailed directions on informed consent, registration of the institutional ethics committee and other regulations,” the letter said.
No response came from the hospital when businessline reached out to the hospital and representatives of the clinical trial industry. A response is awaited.
The NGO’s letter said, “Based on the complaint by a local municipal corporator Rajshree Kesari, action has been taken and investigation committee formed. Following the report of the committee, eight doctors have been suspended, but no legal action has been taken, but it is not enough. It is not a matter of just investigators; there should be a detailed investigation by the competent authority.”
Published on April 23, 2025
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