General Definitions according to CDSCO guidance
General Definitions according to CDSCO guidanceAyurvedic, Siddha or Unani drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of [disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of [Ayurvedic, Siddha and Unani Tibb systems of […]
Registration of Bioavailability and Bioequivalence study centre
Application for registration of bioavailability and bioequivalence study centre Application for registration of any bioavailability and bioequivalence study centre with the Central Licencing Authority shall be made to the said authority in Form CT-08. The application under sub-rule (1) shall be accompanied by a fee as specified in the Sixth Schedule and such other information […]
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 […]
Regulation for Conducting trial for New Drug in India
Definition: ) “academic clinical trial” means a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration or new dose or new dosage form, where the results of such a trial are intended to be used […]
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 […]
Regulatory Guidelines for Labelling and Quality Assurance of Medical Devices in India
Introduction: In India, the Central Drugs Standard Control Organization, under the Ministry of Health and Family Welfare, has established comprehensive regulations for the labelling and quality assurance of medical devices. These guidelines aim to ensure the safety, identification, and proper usage of medical devices in the market. The following blog outlines key points from the […]
Regulatory Framework for Clinical Investigations of Medical Devices in India
Introduction: Clinical investigations play a crucial role in the development and evaluation of medical devices, ensuring their safety and efficacy before they reach the market. In India, the regulatory framework for conducting clinical investigations of investigational medical devices is outlined in detailed rules. This blog explores key aspects of these rules, shedding light on the […]
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 […]
Unveiling the Crucial Elements of Medical Device Registration in India
Introduction: Navigating the regulatory landscape for medical devices, whether in vitro diagnostic or other types, involves a meticulous process of documentation and adherence to essential principles. In India, the Central Drugs Standard Control Organization (CDSCO) has outlined a comprehensive set of requirements for device registration. This article explores the key elements that manufacturers and authorized […]