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Showing posts with label IPC. Show all posts
Showing posts with label IPC. Show all posts

Materiovigilance Programme of India – E-Newsletter | Vol. 8, Issue 2, 2026



The latest Materiovigilance Programme of India (MvPI) E-Newsletter – Volume 8, Issue 2 (2026) provides valuable updates on medical device safety, adverse event reporting and ongoing Materiovigilance activities across India.

This issue covers newly approved Medical Device Adverse Event Monitoring Centers (MDMCs), training and educational initiatives, MvPI activities and expert sessions, safety alerts, recommendations to the Central Drugs Standard Control Organisation (CDSCO), reporting modalities, the MvPI network across India, and upcoming workshops and training programmes.

The newsletter also highlights efforts to strengthen Medical Device Adverse Event (MDAE) reporting, including practical approaches to reporting through ADRMS and capacity-building initiatives for healthcare professionals and other stakeholders.

Of particular interest for pharmaceutical, medical-device, QA, regulatory and healthcare professionals are the recommendations made to CDSCO concerning issues associated with devices such as IV cannulas, single-use syringes, syringe pumps and intravenous infusion sets.

The newsletter is a useful reference for professionals looking to stay informed about developments in medical device safety, materiovigilance, adverse event reporting and regulatory initiatives in India.

Read the complete MvPI E-Newsletter below.

Source: National Coordination Centre – Materiovigilance Programme of India, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India.

#Materiovigilance #MvPI #MedicalDeviceSafety #MedicalDevices #PatientSafety #Pharmacovigilance #DrugSafety #MDAE #AdverseEventReporting #ADRMS #CDSCO #IndianPharmacopoeiaCommission #HealthcareSafety #RegulatoryAffairs #PharmaceuticalIndustry #MedicalDeviceRegulation #Healthcare #QualityAssurance #PharmaUpdates #PharmaNews #IndiaPharma


Pharmacovigilance Guidance Document Version 2.0


This Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products in India is in accordance with the objective of Drugs and Cosmetics Act, 1940 & Rules, 1945 including NDCT Rules 2019. This guidance document is prepared by the National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) in collaboration with Central Drugs Standard Control Organization (CDSCO) to facilitate submission of the safety profile of drugs by MAHs (MAH refers to manufacturer, marketer or the importer of the drug, who has valid manufacturing, marketing or import licence in India). This guidance document defines the roles & responsibilities of CDSCO, State(s)/UT(s) Drugs Controller, NCC-PvPI, IPC and MAHs in preparation of Pharmacovigilance System Master File by MAHs, Post Marketing Surveillance of Pharmaceutical Products, Preparation & Submission of Periodic Safety Update Report (PSUR), Quality Management System (QMS) at MAH organization, Audits and Inspection of Pharmacovigilance System at MAH organization and submission of Risk Management Plan, wherever applicable. This guidance document also provides assistance to MAHs on establishing and ensuring an elective Pharmacovigilance System at their organization. This guidance document may be amended from time to time after obtaining necessary approvals from the concerned authorities. To publish the Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products, Version 2.0, Expert Committee was constituted. 

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