Revista de Farmacovigilância

Abstrato

An Overview of World-Wide Master Key for Drug Safety Monitoring (Pharmacovigilance) and Its Role in India

Janmejay Pant, Harneet Marwah, Ripudaman Singh, Subhajit Hazra

Pharmacovigilance (PV) described as science & actions connecting to the identification, evaluation, awareness, & mitigation of Adverse Drug Reactions (ADRs) or associated conditions. Some serious cases of ADR contributed to the development of this discipline in the 1970s. There have been many efforts to establish such a programme in India between 1989-2004, but the system has finally begun in 2010 and is functioning successfully and achieving meaningful results. Based on the data gathered via this method, Pharmacovigilance Program of India (PvPI) contributed various data to the World Health Organization (WHO) Uppsala Monitoring Centre (UMC). They also issued some warnings to the stakeholder and made a range of suggestions to the Central Drugs Standard Control Organisation (CDSCO). CDSCO has also advised Marketing Permit Holders (MAHs) to comply with the same requirements and has introduced relevant changes to the Drugs and Cosmetics Act & Regulations. The time has arrived when Indian regulatory authorities would undertake the requisite action on the basis of data produced in our country rather than on the basis of data generated in several other countries