Latest news with #GoodClinicalPractices
Economic Times
6 days ago
- Business
- Economic Times
Syngene International shares in focus after positive USFDA updates for 2 Bengaluru facilities
Syngene International shares: The company received two important updates from the U.S. Food and Drug Administration (USFDA). Syngene International shares:The initial update concerns a Good Clinical Practices (GCP) compliance inspection carried out at Syngene's Semicon Park facility in Bengaluru between June 9 and June 13, 2025. The inspection resulted in no findings, and no Form 483 was issued. It was classified as 'No Action Indicated' (NAI), indicating full adherence to regulatory standards. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Shares of Syngene International are expected to be in focus on Monday, June 16, 2025, after the company received two significant updates from the United States Food and Drug Administration (USFDA) concerning inspections at its facilities in first update relates to a Good Clinical Practices (GCP) compliance inspection conducted at Syngene's Semicon Park facility, Bengaluru, from June 9 to June 13, 2025. The inspection concluded with zero observations, and no Form 483 was issued. The inspection was classified as 'No Action Indicated' (NAI), signifying full compliance with regulatory a separate development, the USFDA also concluded its review of an earlier inspection held between February 10 and February 20, 2025, at Syngene's GMP manufacturing facilities in Biocon Park, SEZ, Bengaluru. The company received the Establishment Inspection Report (EIR) on June 11, 2025. The inspection was classified as 'Voluntary Action Indicated' (VAI), and the USFDA has accepted Syngene's responses and Corrective and Preventive Action (CAPA) plans submitted in response to the inspectional updates indicate regulatory progress and compliance, which could be seen positively by the company has stated that it will continue to provide periodic updates to the USFDA and remains committed to the highest standards of compliance. It also clarified that the inspection outcomes will not have any adverse impact on its financials or a separate regulatory filing, the company also confirmed the resignation of Ms. Priyadarshini Mahapatra from the position of Head Legal, Company Secretary & Compliance Officer, effective from the close of business hours on June 9, 2025. Her resignation was previously communicated on April 23, 2025. Syngene International shares closed 1.6% lower at Rs 652.50 on the BSE.: Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
Time of India
6 days ago
- Business
- Time of India
Syngene International shares in focus after positive USFDA updates for 2 Bengaluru facilities
Shares of Syngene International are expected to be in focus on Monday, June 16, 2025, after the company received two significant updates from the United States Food and Drug Administration (USFDA) concerning inspections at its facilities in Bengaluru. The first update relates to a Good Clinical Practices (GCP) compliance inspection conducted at Syngene's Semicon Park facility, Bengaluru, from June 9 to June 13, 2025. The inspection concluded with zero observations, and no Form 483 was issued. The inspection was classified as 'No Action Indicated' (NAI), signifying full compliance with regulatory expectations. In a separate development, the USFDA also concluded its review of an earlier inspection held between February 10 and February 20, 2025, at Syngene's GMP manufacturing facilities in Biocon Park, SEZ, Bengaluru. The company received the Establishment Inspection Report (EIR) on June 11, 2025. The inspection was classified as 'Voluntary Action Indicated' (VAI), and the USFDA has accepted Syngene's responses and Corrective and Preventive Action (CAPA) plans submitted in response to the inspectional findings. These updates indicate regulatory progress and compliance, which could be seen positively by the market. Also read: Bajaj Finance stock split, bonus issue: Here's how your 10 shares will turn into 100 Live Events The company has stated that it will continue to provide periodic updates to the USFDA and remains committed to the highest standards of compliance. It also clarified that the inspection outcomes will not have any adverse impact on its financials or operations. In a separate regulatory filing, the company also confirmed the resignation of Ms. Priyadarshini Mahapatra from the position of Head Legal, Company Secretary & Compliance Officer, effective from the close of business hours on June 9, 2025. Her resignation was previously communicated on April 23, 2025. Syngene International shares closed 1.6% lower at Rs 652.50 on the BSE. ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
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."
