The Central Drugs Standard Control Organization (CDSCO) on February 17, 2026, issued a notification mandatory inclusion of CNS adverse effects in Doxycycline Prescribing Information.
The following has been stated: -
•The Pharmacovigilance Programme of India (PvPI) identified CNS-related adverse drug reactions (restlessness, anxiety, irritability, nervousness, and dizziness) linked to Doxycycline based on ADR assessments.
•The Central Drugs Standard Control Organization (CDSCO), after review by its Subject Expert Committee, accepted the recommendation.
•State Drugs Controllers have been asked to direct manufacturers to include these CNS side effects in the Prescribing Information Leaflet (PIL).
•Manufacturers must update the caution section of package inserts and promotional literature accordingly and report compliance.
The detailed notification is given in the document below.
[Notification No.: File No. PSUR-13011(14)/1/2025-eoffice-Part (2)]
