CDSCO Asks Pharma Firms to Update Vancomycin Labels with DRESS Syndrome ADR
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has directed all State and Union Territory licensing authorities to instruct manufacturers of vancomycin formulations to update the promotional literature of the drug and package inserts of their products by including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Syndrome as a recognised adverse drug reaction (ADR).
The directive, issued by the Office of the Drugs Controller General (India) [DCG(I)] on July 6, 2026, follows a multi-stage pharmacovigilance assessment undertaken under the Pharmacovigilance Programme of India (PvPI) and subsequent expert review by the Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic Drugs.
The National Coordination Centre for Pharmacovigilance Programme of India (NCCPvPI), Indian Pharmacopoeia Commission (IPC), Ghaziabad, has forwarded recommendations arising from the assessment of Adverse Drug Reaction (ADR) reports pertaining to Vancomycin formulations, which was discussed in 25th Signal Review Panel dated 30th October, 2024.
In the meeting, the PvPI has evaluated the Patient Population Incidence - Adverse Drug Reactions (PPIs-ADR) based on Individual Case Study Reports (ICSR) and made recommendation to CDSCO to take necessary measures to incorporate "Dress Syndrome" as an adverse drug reaction in to the Prescribing information leaflet (PIL) of the Vancomycin based medical products marketed in the country.
Earlier, the Medical Dialogue Team had reported that the Indian Pharmacopoeia Commission (IPC) had revealed vancomycin, a tricyclic glycopeptide antibiotic, was linked with adverse drug reactions (ADRs) named Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Syndrome. In connection with the above, the Indian Pharmacopoeia Commission (IPC) had cautioned healthcare professionals to diligently monitor the potential occurrence of adverse drug reactions (ADRs) when administering vancomycin.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Syndrome is a rare but potentially life-threatening drug-induced hypersensitivity reaction that typically develops several weeks after starting the offending medication and is characterized by fever, extensive skin rash, facial swelling, enlarged lymph nodes, eosinophilia, and involvement of internal organs such as the liver, kidneys, lungs, and heart.
"CDSCO should request the State Drugs Controllers to direct the manufacturers to incorporate 'Dress Syndrome' associated with Vancomycin as ADR in the corresponding Prescribing Information Leaflet (PIL) of the drug."
The recommendation of the SEC has been considered by this office. Accordingly, CDSCO has instructed all State and UT Licensing Authorities saying, .
"You are requested to direct the manufacturers of Vancomycin formulations under your jurisdiction to mention "Dress Syndrome" as an adverse drug reaction in the Package insert/Promotional Literature of the drug."
To view the official notice, click the link below:
