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Indian Pharmacopoeia Commision (IPC), Ghaziabad recently released Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products in October 2017. Marketing Authorization Holder (MAH) refers to Pharma company or Sponsor. This document provides Pharmacovigilance guidance for Marketing Authorization Holders of Pharmaceutical Products.
This document is effective from 01 Jan 2018.
The pharmacovigilance guidance document was developed by the National Coordination Centre of the Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission, in collaboration with the Central Drugs Standard Control Organization (CDSCO) and Ministry of Health & Family Welfare (MoHFW).
The objective of the guidance document is to ensure that a pharmacovigilance system is established at the Marketing Authorization Holder’s end in order mitigate risks associated with pharmaceutical products.
The guidance document also states that “it is required under rule to monitor adverse drug reactions/ complaints related to drugs marketed in the country by the MAH & submit it to the licensing authority / NCC PvPI” (Refer B.1.1)