The National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI), under the Indian Pharmacopoeia Commission, reviewed Adverse Drug Reaction (ADR) reports on Carbimazole during the 26th Signal Review Panel meeting in March 2025. Based on Individual Case Study Reports, agranulocytosis was identified as a significant risk. NCC-PvPI recommended its inclusion in the Prescribing Information Leaflet (PIL). The Subject Expert Committee on Endocrinology and Metabolism, meeting in January 2026, endorsed this and advised CDSCO to instruct State Drugs Controllers to ensure manufacturers update PILs accordingly.
The National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI), operating under the Indian Pharmacopoeia Commission (IPC), Ghaziabad, assessed Adverse Drug Reaction reports related to Carbimazole formulations during the 26th Signal Review Panel meeting on 24 March 2025.
Based on Individual Case Study Reports (ICSRs), the Patient Population Incidence of ADRs (PPIs-ADR) indicated a significant risk of agranulocytosis.
Consequently, NCC-PvPI recommended that the Central Drugs Standard Control Organization (CDSCO) incorporate agranulocytosis as a listed adverse drug reaction in the Prescribing Information Leaflet (PIL) of Carbimazole-based products marketed in India.
These recommendations were subsequently reviewed by the Subject Expert Committee (SEC) on Endocrinology and Metabolism at CDSCO headquarters, New Delhi, on 6 January 2026.
After detailed deliberations, the SEC endorsed the proposal and advised CDSCO to instruct State Drugs Controllers to direct manufacturers to update the PILs accordingly, ensuring patient safety and regulatory compliance.