Periodic Safety Update Report for Pharmacovigilance and safety monitoring
The Indian guidance regarding pharmacovigilance system has given description about the preperation and submission of periodic safety update reports. Introduction: The Periodic Safety Update Report is a document for evaluation of the benefit-risk profile of a pharmaceutical product submitted by the MAH at defined time points as per Drugs and Cosmetics Act, 1940 and Rules thereunder during […]
Pharmacovigilance System Master File for India
The Pharmacovigilance guidance document for Marketing Authorization Holders of Pharmaceutical Products stated following thing regarding Pharmacovigilance System Master file PSMF. Content of PSMF Module 1 1.1 Introduction The CDSCO should make a regulatory decision regarding the safety and efficacy of pharmaceutical goods based on the expert committee’s analysis. The data that surface after the first […]
Pharmacovigilance System of India
Pharmacovigilance system in India The guidance is being provided by the Indian Pharmacopoeia Commission. The Pharmacovigilance Guidance Document for Marketing Authorization Holders for Pharmaceutical Products describes the following points. Objective The purpose of this paper is to support MAHs and other related stakeholders who actively participate in the introduction, dissemination, and delivery of pharmaceutical products […]
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 […]