If your formulation plant is an asset, WHO-GMP vs USFDA compliance is its operating manual. Choosing the wrong compliance focus (or delaying upgrades) isn’t just a budget issue — it’s a market access and reputational risk that can cost far…
The Central Drugs Standard Control Organisation (CDSCO), India’s national regulatory body for pharmaceuticals and medical devices, has released its monthly report for October 2024, where it identified several batches of medicines as spurious. This critical regulatory alert is part of…
The Central Drugs Standard Control Organization (CDSCO) has released the “Not of Standard Quality” NSQ drugs alert for October 2024. This monthly update aims to inform stakeholders about pharmaceutical products that have failed to meet quality standards. It is an…
In a surprise order vide gazzete notification, the Health and Family Welfare Ministry, Government of India issued a 156 FDCs ban drugs list 2024. , The matter was examined by an Expert Committee appointed by the Central Government and the…
For pharmaceutical manufacturers in India, complying with Schedule M – the cornerstone of Good Manufacturing Practices (GMP) – has long been the game. But the winds of change have blown, ushering in a revised Schedule M, promising a more robust…
What are the key features of Revised Schedule M for manufacturing companies? Ministry of Health and Family Welfare, Government of India, issued a notification regarding the implementation of revised Schedule-M 2024 by all pharmaceutical formulation companies in India. The initial…
What are the ICH Guidelines? ICH stands for International Conference on Harmonisation, which is a committee that provides a framework for the stability of products in the pharmaceutical industry. ICH guidelines are adopted by every country in the world for…
The pharmaceutical industry is a heavily regulated industry. Here are lots of certification concepts applicable to the quality of products. GMP and GLP are two popular existing certifications that stand for Good Manufacturing Practice and Good Laboratory Practice respectively. Similarly,…
 New Drugs List 2021& 2022 approved by CDSCO The Central Drugs Standard Control Organization (CDSCO) issued another new drug approval list for the years 2021 and 2022, In these two years, CDSCO issued two new drugs the first new drug…