CDSCO Directs Ibuprofen Manufacturers to Add ‘Fixed Drug Eruption’ to PILs

Issued by: Drugs Controller General (India), Post Marketing Drugs Safety Monitoring Division  |  Dated: 21 July 2026  |  Addressed to: All State/UT Licensing Authorities

The Central Drugs Standard Control Organisation (CDSCO) has directed all State/UT Licensing Authorities to instruct Ibuprofen manufacturers to add ‘Fixed Drug Eruption’ as an adverse drug reaction (ADR) to the Prescribing Information Leaflet (PIL) and promotional literature of Ibuprofen-based formulations. The direction, issued under File No. PMDSM-14011(27)/17/2026-eoffice and signed by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), follows a pharmacovigilance signal confirmed through India’s national ADR surveillance system.

Background: How the Signal Was Identified and Confirmed

The update traces back to India’s Pharmacovigilance Programme of India (PvPI), coordinated by the National Coordination Centre (NCC-PvPI) at the Indian Pharmacopoeia Commission (IPC), Ghaziabad. NCC-PvPI continuously evaluates Individual Case Safety Reports (ICSRs) submitted through the ADR reporting network and periodically presents emerging safety signals to the Signal Review Panel for formal assessment.

At its 24th Signal Review Panel meeting held on 2 November 2023, the panel evaluated the Patient Population Incidence–Adverse Drug Reaction (PPIs-ADR) data derived from ICSRs relating to Ibuprofen formulations. Based on this evaluation, the panel recommended that CDSCO take steps to incorporate ‘Fixed Drug Eruption’ as an ADR in the PIL of Ibuprofen-based medical products marketed in India.

This recommendation was subsequently placed before the Subject Expert Committee (Analgesics & Orthopedics), which reviewed it at a meeting held on 7 May 2026 at CDSCO Headquarters, New Delhi. After detailed deliberation, the SEC concurred with the NCC-PvPI recommendation and advised CDSCO to request State Drug Controllers to direct manufacturers accordingly.

Timeline of the Regulatory Process

What This Means for Ibuprofen Manufacturers

Ibuprofen is one of the most widely marketed NSAIDs in India, manufactured across an extensive base of formulation units under state licenses. The direction requires manufacturers to update two distinct materials:

• Prescribing Information Leaflet (PIL): The ADR section must now list ‘Fixed Drug Eruption’ alongside existing listed reactions for Ibuprofen formulations.
• Promotional literature: Any promotional material referencing the safety profile of the product must also reflect this addition, consistent with the requirement to keep promotional claims aligned with approved labelling.

Who Needs to Act

• Manufacturers holding manufacturing licenses for Ibuprofen as a single ingredient or in fixed-dose combinations, under the jurisdiction of the respective State/UT Licensing Authority.
• Marketing Authorisation Holders and loan licensees responsible for the content of PILs and promotional material for Ibuprofen-based products.
• State/UT Licensing Authorities, who are required to issue directions to manufacturers in their jurisdiction and report action taken back to the DCG(I)’s office.

Regulatory Context: Fixed Drug Eruption as an ADR

Fixed Drug Eruption (FDE) is a well-documented cutaneous adverse drug reaction characterised by recurrence of lesions at the same skin site on re-exposure to the causative agent. NSAIDs, including Ibuprofen, are recognised in pharmacovigilance literature as a reported class associated with FDE. The present direction formalises this association within statutory labelling requirements for the Indian market, aligning PIL content with the confirmed pharmacovigilance signal rather than leaving it to voluntary disclosure.

The circular does not specify a compliance timeline or a transition period for exhausting existing packaging stock; State/UT Licensing Authorities and manufacturers should treat the direction as requiring updates to labelling content going forward, and should seek written clarification from the CDSCO/State Licensing Authority where a specific implementation timeline is required for stock-in-hand.