Overview
- Letters dated February 17 from the DCGI instruct State and Union Territory regulators to have manufacturers update prescribing information and to report compliance.
- For doxycycline, manufacturers must add central nervous system adverse reactions that include restlessness, anxiety, irritability, nervousness and dizziness.
- For carbimazole, manufacturers must include agranulocytosis as an adverse reaction, with early warning signs such as fever, sore throat and unexplained infections.
- The updates stem from assessments by the Pharmacovigilance Programme of India, discussion at Signal Review Panel meetings, and endorsement by Subject Expert Committees.
- No recalls or restrictions were announced, with regulators stating the goal is clearer risk communication to support clinician counselling and patient awareness.