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

The Drugs Control Department has directed cause manufacturers to revise the information hazard labelling for Doxycycline and Carbimazole formulations.

In a circular, E. Anandakirouchenane, Controlling and Licensing Authority of the department, instructed manufacturers to follow mandatory revision of the Prescribing Information Leaflet for the 2 formulations connected the ground of a Central directive.

The Drugs Control authorities asked each pharmaceutical manufacturers of Doxycycline and Carbimazole formulations to revise the Prescribing Information Leaflet (PIL) and Promotional Literature by incorporating the pursuing information updates: the Central Nervous System (CNS) adverse effects namely Restlessness, Anxiety, Irritability, Nervousness and Dizziness successful the lawsuit of Doxycycline formulations and “Agrarulocytosis” arsenic adverse absorption 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 appraisal of Adverse Drug Reaction (ADR) reports relating to Doxycycline and Carbimazole formulations, the circular stated.

These findings had been deliberated astatine the 26th Signal Review Panel gathering held successful 2025, and consequent evaluations carried retired by the Subject Expert Committees (SECs) of the Central Drugs Standard Control Organisation (CDSCO), it said.

All cause manufacturers successful the Union Territory are required to strictly comply with the directive and besides taxable the revised PIL to the section for grounds and verification, the circular stipulated.