CDSCO Seeks to List Bullous Pemphigoid as Teneligliptin Adverse Reaction
The National Coordination Centre for the Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission (IPC), Ghaziabad, had forwarded recommendations arising from an assessment of adverse drug reaction reports relating to Teneligliptin formulations. The matter was discussed at the 24th Signal Review Panel meeting held on November 2, 2023.
At that meeting, PvPI evaluated Patient Population Incidence–Adverse Drug Reactions (PPIs-ADR) based on Individual Case Study Reports (ICSR). It recommended that CDSCO take the necessary measures to incorporate Bullous Pemphigoid as an adverse drug reaction in the prescribing information leaflets of Teneligliptin-based medical products marketed in the country.
The NCC-PvPI recommendations were subsequently reviewed by the SEC on Endocrinology and Metabolism at its meeting held on April 23, 2026, at CDSCO headquarters in New Delhi.
Following detailed deliberations, the committee recommended that CDSCO request State Drugs Controllers to direct manufacturers to include Bullous Pemphigoid associated with Teneligliptin as an adverse drug reaction in the corresponding prescribing information leaflet.
After considering the SEC recommendation, the DCGI’s office asked the licensing authorities to direct manufacturers under their jurisdiction to make the addition in the drug’s package insert and promotional literature.
“Accordingly, you are requested to direct the manufacturers of Teneligliptin formulations under your jurisdiction to mention ‘Bullous Pemphigoid’ as an adverse drug reaction in the Package insert/Promotional Literature of the drug,” the notice stated.
The notice also requested that the action taken be intimated to the DCGI’s office.
To view the official notice, click the link below:
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