The National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI) reviewed ADR reports on Doxycycline during the 26th Signal Review Panel in March 2025. Based on Individual Case Study Reports, CNS side effects as restlessness, anxiety, irritability, nervousness, and dizziness were identified. T he Subject Expert Committee on Antimicrobial and Antiparasitic drugs, meeting in January 2026, endorsed inclusion of these reactions in the Prescribing Information Leaflet and caution section, ensuring patient safety and transparency.
The National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI), under the Indian Pharmacopoeia Commission (IPC), Ghaziabad, reviewed Adverse Drug Reaction (ADR) reports related to Doxycycline 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) highlighted Central Nervous System (CNS) side effects such as restlessness, anxiety, irritability, nervousness, and dizziness. NCC-PvPI recommended that CDSCO incorporate these reactions into the Prescribing Information Leaflet of Doxycycline-based products marketed in India.
The recommendations were subsequently examined by the Subject Expert Committee (SEC) on Antimicrobial and Antiparasitic drugs during its meeting on 8 January 2026 at CDSCO headquarters, New Delhi. After detailed deliberations, the SEC endorsed the proposal and advised CDSCO to instruct State Drugs Controllers to direct manufacturers to update PILs accordingly.
The committee also recommended inclusion of these CNS side effects in the caution section of PILs, package inserts, and promotional literature to enhance patient safety and regulatory transparency.