Application for conducting Bioavailability or Bioequivalence study
Any person or institution or organisation which intends to conduct bioavailability or bioequivalence study of a new drug or an investigational new drug in human subjects shall obtain permission for conducting bioavailability or bioequivalence study from the Central Licencing Authority by making an application in Form CT-05. The Central Licencing Authority may, after scrutiny of […]
Registration of Clinical Research Organization
Definition: ‘Clinical Research Organisation’ means any commercial or academic or any other category of body ownedby an individual or an organization having the status of a legal entity by whatever name called, which is engagedin conducting clinical trials; Assign or transfer related functions, duties and/or commitments, provided thatcontractual transfers or commitments are to be transferred […]
Navigating the Regulatory Landscape: Sales of Medical Devices in India
Introduction: The sale of medical devices is a critical aspect of the healthcare ecosystem, ensuring that innovative and safe technologies reach patients and healthcare providers. In India, the regulatory framework for the sale of medical devices is outlined in specific rules, providing guidelines for licensing, supply to hospitals, and recall procedures. In this article, we […]