Import of Medical Devices to Inida
The CDSCO has provided the guidance for importing medical device in India. It being stated in the guidance that: Application for grant of import licence.— (1) An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, shall make an application for grant of import […]
Navigating the Regulatory Landscape: Essential Documentation for Medical Device Licenses in India
Introduction: In the dynamic world of healthcare, the import, manufacture, and distribution of medical devices are subject to stringent regulations to ensure the safety and efficacy of these products. In India, the Central Drugs Standard Control Organization (CDSCO) has outlined specific requirements for the issuance of licenses for medical devices. This blog explores the crucial […]
Quality Management system at Marketing authorization holder organization
These topic comes under the guidance of Pharmacovigilance: Introduction: This module contains guidance for the establishment and maintenance of quality assured Pv system for MAHs for performing their Pv activities; MAHs shall establish and use quality systems that are adequate and effective for the performance of Pv activities. Structure and processes A Pv system is […]
Collection, Processing & Reporting of Individual Case Safety Reports
The guidance of pharmacovigilance for Marketing authorization holders in India has described the following points regarding collection, processing and reporting of ICSR (individual case safety reports) Under-reporting of AEs/ADRSs is a well-known problem associated with spontaneous reporting, therefore, MAHSs shall have different sources/methods to report AEs/ADRs to the organization. The following sources/methods required to be […]
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 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 […]