Animal Toxicology studies as per the CDSCO Guidance
General Principles: Toxicity studies should comply with the norms of Good Laboratory Practices (GLP). Briefly, these studies should be performed by suitably trained and qualified staff employing properly calibrated and standardized equipment of adequate size and capacity. Studies should be done as per written protocols with modifications (if any) verifiable retrospectively. Standard operating procedures (SOPs) […]
Import of New drug/Investigational drug for clinical trials
Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or The application under sub-rule (2) shall be accompanied by […]
Manufacture of Medical Devices for sale or for distribution
According to the guidance provided by the CDSCO on Medical device manufacturing and distribution: Application for manufacture for sale or for distribution of Class A or Class B medical device.— (1) Any person who intends to manufacture a Class A or Class B medical device including in vitro diagnostic medical device shall make an application […]
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 […]
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 […]
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 […]