Panel asks CDSCO to scrutinize report on adverse reaction of HCQ

However, as per the National Pharmacovigilance Programme of India (PvPI), there have been over 100 reported instances of adverse drug reactions associated with prophylactic use of HCQ, some being serious, reports Economic Times.

PvPI is a wing under CDSCO which collates data on reported side-effects and adverse events of medicines used in India, analyses it and uses the inferences to recommend regulatory interventions.

"The ICSR by PvPI was deliberated by the committee," said the minutes of the meeting, held on 22 October.

To mention, ICSR is an important document in which an adverse event is reported for an individual patient. This document provides data for pharmacovigilance (science and activities relating to the detection, assessment and prevention of adverse effects) to assess the safety of medicines taken by a patient.

After detailed deliberation the committee opined that CDSCO should communicate to the PvPI to further examine if any other reported adverse drug reaction (ADR) has been received by them for taste disorder and urinary incontinence.

"If so, details should be obtained for further consideration," SEC added.

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