Assisted Reproductive Technology Procedures

Mr. Karthi Thiyagarajan

Sale of In-Vitro Fertilization Media, Reagents and related Consumables used in Assisted Reproductive Technology Procedures The Apex Drug and Medical Device Regulator has strictly restricted the supply of critical Laboratory Consumables used in In-Vitro Fertilization (IVF) and Assisted Reproductive Technology… 

Regulatory Alert – CDSCO

Mr. Karthi Thiyagarajan

CDSCO Suspends HCG Bengaluru Ethics Committee for 2 Years Over Critical Clinical Trial Lapses

India’s top drug regulator, the CDSCO, has slapped a 24-month suspension on the Ethics Committee of the HCG Bangalore Institute of Oncology. Following a risk-based inspection, regulators uncovered severe compliance failures, including delayed reporting of serious adverse events (including participant deaths), glaring conflicts of interest, and inadequate medical management for trial subjects. While the committee is barred from approving new studies, it must continue monitoring active trials under strict regulatory supervision. Read on for a deep dive into the findings and what this means for clinical trial oversight in India.

Clinical Establishments Act

Mr. Karthi Thiyagarajan

Draft Gazette Notification of Minimum Standards for Clinical Establishments The Ministry of Health & Family Welfare, through the Directorate General of Health Services, has issued a draft Gazette Notification dated March 10, 2026, proposing updated minimum standards for several categories… 

CDSCO Notification

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Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f 01.10.2022 – Regulator’s Notification MoHFW has released a recent notification on Sep 30th 2022 about the Registration / Licensing norms for Medical Device Manufacturers, Importers for Class… 

CDSCO Announcement on License

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CDSCO – Announcement related to Suspension of License – Medical Device Industry – Med Dev Amendment Rules 2021 NOTIFICATION FROM MINISTRY OF HEALTH AND FAMILY WELFARE Dt 18th January, 2022 Content of the notification : G.S.R. 23(E).—The following  draft  of …