Drug makers to add TEN, SJS in package insert of Ciprofloxacin: CDSCO panel

The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has recommended that CDSCO may request State Drugs Controllers to direct the manufacturers of Ciprofloxacin to incorporate drug associated Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN) in the package insert of the drug.

This came in line with the recommendation of the signal review panel, Pharmacovigilance Programme of India (PvPI), and the Indian Pharmacopoeia Commission (IPC), which was placed before the committee.

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Drug makers to add SJS, TEN in package insert of Ciprofloxacin: CDSCO panel