DCGI specifies select countries for considering waiver of clinical trials for five specific categories of new drugs
The Drugs Controller General India (“DCGI”) has identified specific countries under the Rule 101... Read More
CDSCO mandates adoption of WHO Guidelines on Good Manufacturing Practices for vaccine and sterile product manufacturers
The Central Drugs Control Standards Organization (CDSCO) has recently issued a Circular directing... Read More
CDSCO mandates online-only submissions in Form-44 for veterinary drugs through SUGAM portal, ending offline options
With a view to streamline the regulatory submission procedure, the veterinary division of the... Read More
Union Health Ministry mandates registration of Clinical Research Organizations under New Drugs and Clinical Trials Amendment Rules, effective 1st April, 2025
The Union Health Ministry has notified the New Drugs and Clinical Trials (Amendment) Rules, 2024... Read More