SEC Asks DCGI To Dig Out Details About ‘Side-Effects’ Of HCQ

New Delhi : The Narendra Modi government has recommended to the Central Drugs Standard Control Organisation (CDSCO), the country’s apex health regulatory body, to find out more details about the reported side-effects of anti-malarial drug Hydroxychloroquine (HCQ).

The government’s Subject Expert Committee (SEC) — which advises the Drug Controller General of India on applications seeking approvals for new drugs, vaccines and clinical trials — held an “internal discussion” on the topic “Hydroxychloroquine (HCQ) used for management of situation arising due to Covid-19” last week.

The panel has suggested that CDSCO — the health ministry arm that regulates the quality of drugs and vaccines in India — find out more details about side-effects of HCQ, particularly those related to taste disorder and urine incontinence.

The SEC had deliberated on the “individual case study report (ICSR)” submitted by the Pharmacovigilance Programme of India (PvPI), 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, and which has been uploaded on the CDSCO website.

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.

Reported adverse drug reactions

The SEC has recommended that CDSCO asks PvPI to dig out more details about the side-effects of HCQ, according to the minutes of the meeting.

The panel told CDSCO that “it should communicate to the PvPI to further examine if any other reported adverse drug reactions (ADR) has been received by them for taste disorder and urinary incontinence”.

“If so, details should be obtained for further consideration,” the panel added.

HCQ was among the first few drugs suggested to be effective against Covid-19 during the initial phases of the pandemic’s outbreak.

According to the government’s guidelines, the drug continues to be on the recommendation for prophylaxis and treatment of Covid-19 despite several evidences of its inefficacy.


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