The Central Drugs Standard Control Organization (CDSCO), on February 17, 2026, notified regarding the directive to Update Prescribing Information for Carbimazole to Include Agranulocytosis as an ADR.
The following has been stated namely: -
• The National Coordination Centre for Pharmacovigilance Programme of India (NCCPvPI), under the Indian Pharmacopoeia Commission (IPC), Ghaziabad, reviewed adverse drug reaction (ADR) reports related to Carbimazole formulations during the 26th Signal Review Panel meeting held on 24 March 2025.
• Based on the evaluation of Patient Population Incidence–ADR (PPIs-ADR) data from Individual Case Safety Reports (ICSRs), PvPI recommended that “agranulocytosis” be included as an adverse drug reaction in the Prescribing Information Leaflet (PIL) of Carbimazole products. This recommendation was subsequently examined by the Subject Expert Committee (SEC) on Endocrinology and Metabolism at CDSCO Headquarters, New Delhi, on 6 January 2026.
• After detailed deliberation, the SEC advised CDSCO to instruct State Drugs Controllers to direct manufacturers to incorporate agranulocytosis as an ADR in the PIL and promotional literature of Carbimazole formulations. The recommendation has been accepted, and authorities have been requested to ensure compliance by manufacturers under their jurisdiction.
[Notification No. PSUR-13011(14)/1/2025-eoffice-Part (2)]
