Latest news with #NewDrugsandClinicalTrialsRules
Time of India
06-05-2025
- Health
- Time of India
DGCI begins probe into ‘illegal' clinical trials at VS Hospital
SLUG: CENTRAL AGENCY BEGINS PROBEAhmedabad: A team from the regional office of the Drugs Controller General of India (DCGI) made its first visit to VS Hospital on Monday and initiated a probe into allegations of illegal clinical trials there. The team also visited the Ahmedabad Municipal Corporation (AMC).This development follows allegations involving 58 such clinical trials at VS Hospital. During their visit, the DCGI officials reportedly shared details with a senior AMC senior AMC official revealed to TOI that the inspecting DCGI team stated they "never recalled conducting routine inspections at the VS Hospital clinical trial site over the past four years." This comes despite the significant number of 'unauthorised' trials alleged to have taken place during this period. The senior AMC official further said, "We were told by the DCGI that they never visited VS Hospital as a clinical site, but used to frequent the neighbouring SVP Hospital clinical trial site, which had its own Institutional Ethics Committee (IEC) and were aware of the subjects and drug trials being conducted there."The Supreme Court's intervention on April 30, prompted by a petition from the NGO Swasthya Adhikar Manch (SAM) concerning the alleged irregularities at VS Hospital, appears to have spurred the DCGI's current action. "We supplied a copy of our enquiry committee report to the DCGI, including the action taken by the civic body, the details of the financial transactions, and the action taken against doctors who participated in the alleged illegal trials," the senior AMC official informed Rajshri Kesari, the municipal councillor who initially brought the issue to the forefront, revealed, "I was not approached by the DCGI team."The DCGI's investigation is set to cover crucial aspects of the clinical trials. The AMC official outlined the scope of the probe, stating, "The DCGI inspection team will review the informed consent forms and documentation of the trial subjects and their rights and safety." Also, the ethical oversight mechanisms employed will be examined. "Another crucial aspect of the investigation is the choice of a private ethics committee outside the VS Hospital campus, while neighbouring SVP Hospital had an ethics committee in place," the AMC official pointed out, indicating that the rationale and implications of this arrangement are likely to be DCGI's mandate to ensure adherence to ethical and regulatory guidelines will guide their investigation. "The DCGI will also examine study protocols, CRFs, and source documents to ensure trial activities align with approved protocols and regulatory standards," the AMC official explained."The DCGI checks whether there was conformity with Good Clinical Practices (GCP) guidelines and the New Drugs and Clinical Trials Rules, 2019. Also, it compares sponsor-submitted data with site source documents to ensure data integrity, especially during post-trial or for-cause inspections."
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
30-04-2025
- Health
- Time of India
SC seeks Centre's response on illegal clinical trials at VS
Supreme Court on Wednesday sought the central govt's response to allegations by an NGO that 58 illegal clinical trials have been conducted by national and international pharmaceutical companies in the last four years at the Sheth Vadilal Sarabhai Hospital run by the Ahmedabad Municipal Corporation (AMC). Appearing for the NGO Swasthya Adhikar Manch , senior advocate Sanjay Parikh informed a bench of Justice P S Narasimha and Justice J Bagchi that these trials were conducted in the absence of an ethics committee, which is mandatory under the New Drugs and Clinical Trials Rules, 2019. The allegation about the illegal clinical trials in the hospital was narrated, with support from news reports published in TOI, in an affidavit, which was filed along with the main petition. It highlighted how multinational pharma majors are conducting clinical trials without adhering to the safeguards under the rules and regulations, and treating those undergoing the trials as guinea pigs. Making a serious allegation, the NGO said in its affidavit, "It is reported that the private drug companies have deposited Rs 17-20 crore in doctors' personal bank accounts. After coming to know of these clinical trials, the Ahmedabad municipal commissioner formed an inquiry committee, which in its report highlighted the irregularities in clinical research and financial operations, 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."
