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… 

Professional Certification Scheme

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Draft Chemical Regulatory Compliance Professional Certification Scheme (CRCPCS) Who is RRMA? The Regulatory Representatives and Managers Association (RRMA) is a premier non-profit professional organization dedicated to advancing competency, professional excellence, and capacity building within the field of chemical regulations and… 

Consultant Certification Scheme

Mr. Karthi Thiyagarajan

Draft Medical Device Consultant Certification Scheme from LSSSDC, for public comments Who is LSSSDC? The Life Sciences Sector Skill Development Council (LSSSDC) is a premier, not-for-profit skilling body operational under the aegis of the Ministry of Skill Development and Entrepreneurship (MSDE),… 

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.

RIS Discussion Paper on Quality

Mr. Karthi Thiyagarajan

Discussion Paper on “Reimagining India’s Quality Ecosystem,” published by the Research and Information System for Developing Countries (RIS), New Delhi Research and Information System for Developing Countries (RIS) is a New Delhi-based autonomous policy research institute that specializes in global…