In order to bring clarity on Pharmacovigilance Programme of India (PvPI) towards patient safety, the Union health ministry has asked adverse drug reaction monitoring centres (AMCs) to set up causality assessment committee in each of the 250 AMCs functioning across the country.

This is urgently required as this will effectively help in establishing clinical evidence between the drug and the adverse drug reaction or serious adverse event associated with it in the patient. Each existing AMC has been mandated to follow the same in the interest of patient safety, informed a senior official associated with the development.

Causality or related assessment implies determination of whether there is a reasonable possibility that the product is causally related to the adverse event. Causality assessment includes evaluation of temporal relationships, association with or lack of association with underlying disease, presence or absence of a more likely cause, and biologic plausibility.

It should be emphasized that manufacturers should not separate out those spontaneous reports they receive into those that seem to themselves to be causally related to drug exposure and those they consider not causally related. A physician in making a spontaneous report to a manufacturer is indicating that the observed event may be due to the drug, i.e. the physician suspects that the event is a reaction.

As a practical matter, many companies do causality assessments on spontaneous reports as part of their signal analysis mechanisms.

The Indian Pharmacopoeia Commission (IPC) under the Union health ministry has recently come out with draft protocol and guidelines focused on targeted drugs and events as a part of Intensive adverse drug reaction monitoring exercise under PvPI so that appropriate action can be taken on specific drugs involving adverse events or reactions.

The intensive ADR monitoring protocol which has recently been devised will be implemented in an ongoing manner based on the learnings of the projects undertaken with help from competent institutions. This will help in taking regulatory decisions in a timely manner.
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Institutions have been identified and encouraged in the country to carry out Intensive ADR monitoring as per the guidelines for reporting specific events in a focused manner related to a specific drug.