Pharmacovigilance Programme of India (PvPI) leads ahead with 0.82 points as per quality completeness score of Individual Case Safety Reports (ICSR) as against the global average of 0.55 accounted on a quarterly basis for a total of 150 countries including India which contribute to the global PvP database.

Says a senior PvPI official, “Quality completeness score of ICSR of PvPI as per World Health Organisation (WHO)- Uppsala Monitoring Centre (UMC) (WHO-UMC), Sweden guidelines is far ahead than the rest of the 149 countries which contribute to the global pharmacovigilance programme database.”

ICSR as part of adverse drug reactions (ADRs) are reported from all over the country to National Co-ordination Centre (NCC-PvPI), which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base.

Uppsala Monitoring Centre was the first WHO Collaborating Centre to be established for pharmacovigilance when, in 1978, the scientific and technical responsibility of the WHO Programme for International Drug Monitoring was transferred to Sweden.

The WHO Programme for International Drug Monitoring is a group of more than 150 countries that share the vision of safer and more effective use of medicines. They work nationally and collaborate internationally to monitor and identify the harm caused by medicines, to reduce the risks to patients and to establish worldwide pharmacovigilance standards and systems. UMC has been responsible for the technical and operational aspects of the programme since 1978.

The WHO Programme was created in 1968 to ensure that evidence about harm to patients was collected from as many sources as possible. This would enable individual countries to be alerted to patterns of harm that were emerging across the world and which might not be evident from their local data alone.

PvPI has till date reported around 2.30 lakh adverse drug reactions through its 210 ADR monitoring centres (AMCs) and registered 25% contribution from market authorisation holders (MAH). Around 75% has come from its integration with national health programmes and consumers.  

MAHs collect, process and forward the report to the licensing authority for information on adverse drug reactions emerging from the use of the drug manufactured or marketed by the respective MAH in the country through a gazette notification March 8, 2016.

A pharmaceutical company can meet their pharmacovigilance obligations either by setting up in-house systems for pharmacovigilance or can enter into contractual arrangements with Contract Research Organizations (CROs) specializing in pharmacovigilance function.

List of SOPs for PV Dept involves procedures for collecting the adverse event reports, validating the adverse reaction reports, evaluating the cases for their seriousness, follow up of cases for missing information, expedited reporting, electronic reporting, periodic reports, signal management and risk benefit assessment and response to request for information from regulatory authorities, Interaction between safety issues and product defects, handling of urgent safety restrictions and safety variations, management and use of databases, training, internal audit of the pharmacovigilance system and archiving.