The Department of Health and Family Welfare vide notification dated the 13th January, 2022 has issued the New Drugs and Clinical Trials (Amendment) Rules, 2022. The amendment has extended the scope of new drugs to include cell or stem cell derived product. Previously the definition of new drug under the New Drugs and Clinical Trials Rules only included stem cell derived product.
Extension of timeline for implementation of the Circular titled “Complaint Handling and Grievance Redressal by Regulated Entities in the IFSC”
It has been decided that the said Circular shall now come into force with effect from April 01, 2025. The Regulated Entities are therefore directed