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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