Latest news with #SwasthyaAdhikarManch
Time of India
30-04-2025
- Health
- Time of India
SC seeks Centre response on 'illegal clinical trials' in Gujarat
NEW DELHI: SC Wednesday sought central govt's response to allegations by an NGO that as many as 58 illegal clinical trials have been conducted by national and international pharmaceutical companies in the last four years at Ahmedabad municipal corporation-run Sheth Vadilal Sarabhai Hospital . Appearing for the NGO, Swasthya Adhikar Manch , senior advocate Sanjay Parikh informed a bench of Justices P S Narasimha and J Bagchi that these trials were conducted in the absence of an ethical committee, which is mandatory under New Drugs and Clinical Trials Rules, 2019. The allegation about illegal clinical trials in hospital was narrated, with support from news reports published in TOI, in an affidavit, which was filed in the main petition that highlighted how multinational pharma majors are conducting clinical trials without adhering to the safeguards provided under the rules and regulations, and treating those undergoing clinical trials as guinea pigs. The NGO said, "...After coming to know of these clinical trials, Ahmedabad municipal commissioner formed an inquiry committee, which in its report highlighted the irregularities, and has recommended action against the wrongdoers."
Time of India
24-04-2025
- Health
- Time of India
Oversights raise health safety concerns: Experts
Ahmedabad: The civic body investigating committee's decision to ignore clinical trial subjects, particularly those who come into public hospitals for treatment, raises the serious issue of public health safety, experts say. "Ignoring subjects in the whole investigations means you have exposed vulnerable people to risk because established norms and due process are not being followed at your hospital," observes Amulya Nidhi of Swasthya Adhikar Manch, who is a petitioner in the writ petition civil case No 33 of 2012 in the Supreme Court concerning clinical trials. According to the latest New Drugs and Clinical Trials Rules, 2019, an ethics committee (EC) at a clinical trial site is compulsory and should be appointed by the institutional head, not by the sponsor of the trial. When the Ahmedabad Municipal Corporation (AMC) committee investigating the issue examined clinical trials approved between 2022 and 2024 at VS Hospital and registered with the Clinical Trial Registry, India, a list of new approvals for a range of trials were noticed. These included Phase 3 and Phase 4 trials that cover vaccines for measles, rubella, typhoid and yellow fever, a drug for moderate to severe psoriasis, a treatment for Parkinson's disease, a drug for Type 2 diabetes, and a herbal formulation for mild Covid-19. A senior AMC official told TOI, "If the internal committee doesn't have the capacity to investigate due process, their options are to constitute an independent committee of experts or write to the central authority (like the DCGI or the secretary, ministry of health) to probe the entire issue." Nidhi argues, "If non-financial violations are found during the investigation, the committee must also look into them; focusing only on financial transactions is insufficient."
