Pharma Firms told to Update Prescribing Information Leaflets for Cotrimoxazole, Tetracycline
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has directed all State and Union Territory licensing authorities to instruct manufacturers of Cotrimoxazole and Tetracycline formulations to update their package inserts and promotional literature by including Fixed Drug Eruption (FDE) as a recognised adverse drug reaction (ADR).
The directives, issued by the Office of the Drugs Controller General (India) [DCG(I)] on July 6, 2026, follow separate pharmacovigilance assessments conducted under the Pharmacovigilance Programme of India (PvPI) and subsequent reviews by the Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic Drugs.
For Cotrimoxazole, the National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission (IPC), Ghaziabad, forwarded recommendations arising from the assessment of adverse drug reaction (ADR) reports discussed during the 24th Signal Review Panel meeting held on November 2, 2023.
For Tetracycline, the recommendations were based on ADR reports evaluated during the 25th Signal Review Panel meeting held on October 30, 2024.
In both cases, the PvPI evaluated Patient Population Incidence–Adverse Drug Reactions (PPIs-ADR) using Individual Case Safety Reports (ICSRs) and recommended that CDSCO incorporate Fixed Drug Eruption (FDE) as an adverse drug reaction in the prescribing information leaflets (PILs) of Cotrimoxazole- and Tetracycline-based medicinal products marketed in India.
Fixed Drug Eruption (FDE) is a distinctive cutaneous adverse drug reaction characterized by the recurrence of well-defined reddish or violaceous skin lesions at the same site each time the offending medication is administered. The lesions may be accompanied by itching or burning and typically heal with residual hyperpigmentation after discontinuation of the causative drug. Although most cases are localized, severe and generalized forms can occasionally occur, making early recognition and prompt withdrawal of the offending medicine essential.
The NCC-PvPI recommendations were subsequently reviewed by the Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic Drugs during its meeting held on April 9, 2026, at CDSCO Headquarters in New Delhi.
After detailed deliberations, the committee recommended that CDSCO should request State Drugs Controllers to direct manufacturers to incorporate "Fixed Drug Eruption" as an ADR in the corresponding Prescribing Information Leaflet (PIL) of Cotrimoxazole and "Fixed Drug Eruption (FDE)" as an ADR in the PIL of Tetracycline formulations.
The recommendations have been accepted by the Office of the Drugs Controller General (India).
Accordingly, CDSCO has instructed all State and UT Licensing Authorities saying,
For Tetracycline formulations:
"you are requested to direct the manufacturers of Tetracycline formulations under your jurisdiction to mention "Fixed Drug Eruption" as an adverse drug reaction in the Package insert/Promotional Literature of the drug."
For Cotrimoxazole formulations:
"You are requested to direct the manufacturers of Cotrimoxazole formulations under your jurisdiction to mention "Fixed Drug Eruption" as an adverse drug reaction in the Package insert/Promotional Literature of the drug."
To view the official notices, click the link below:
