Drug manufacturers directed to revise safety risk labelling information for two drug formulations

The Drugs Control Department has directed drug manufacturers to revise the safety risk labelling for Doxycycline and Carbimazole formulations.

In a circular, E. Anandakirouchenane, Controlling and Licensing Authority of the department, instructed manufacturers to adopt mandatory revision of the Prescribing Information Leaflet for the two formulations on the basis of a Central directive.

The Drugs Control authorities asked all pharmaceutical manufacturers of Doxycycline and Carbimazole formulations to revise the Prescribing Information Leaflet (PIL) and Promotional Literature by incorporating the following safety updates: the Central Nervous System (CNS) adverse effects namely Restlessness, Anxiety, Irritability, Nervousness and Dizziness in the case of Doxycycline formulations and “Agrarulocytosis” as adverse reaction of Carbimazole formulations.

This follows recommendations of the National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI), the Indian Pharmacopoeia Commission (IPC), and the conclusions drawn from the assessment of Adverse Drug Reaction (ADR) reports relating to Doxycycline and Carbimazole formulations, the circular stated.

These findings had been deliberated at the 26th Signal Review Panel meeting held in 2025, and subsequent evaluations carried out by the Subject Expert Committees (SECs) of the Central Drugs Standard Control Organisation (CDSCO), it said.