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The Central Drugs Standard Control Organisation (CDSCO) has directed all State Licensing Authorities (SLAs) to mandate the manufacturers of anti-diabetic drug teneligliptin that the package insert of the promotional literature should mention a rare skin condition Bullous Pemphigoid as an adverse drug reaction (ADR).
The decision follows a recommendation by the National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI), under the Indian Pharmacopoeia Commission (IPC), and an expert committee which advises the drugs regulator.
Bullous Pemphigoid is a rare, autoimmune skin condition indicated through large fluid-filled blisters that may be painful and usually itchy.
The NCC-PvPI has forwarded recommendations following the assessment of ADR reports on teneligliptin formulations. These recommendations were discussed in 24th Signal Review Panel, which consists of national, experienced medical professors, regulatory authority members usually affiliated to a governmental or academic institution invited by NCC, on November 2, 2023.
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 Bullous Pemphigoid as an adverse drug reaction in to the Prescribing information leaflet (PIL) of the teneligliptin-based medicinal products marketed in the country.
These recommendations of NCC-PvPI were subsequently reviewed by the Subject Expert Committee (Endocrinology and Metabolism) during its meeting held on April 23, 2026 at the headquarters of CDSCO, in New Delhi.
After detailed deliberations, the committee recommended that CDSCO should request the State Drugs Controllers to direct the manufacturers to incorporate the ADR in the PIL of the drug.
"The recommendation of the SEC has been considered by this office. 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," said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India) in a circular from the Post Marketing Drugs Safety Monitoring Division. He also sought the SLAs to intimate the action taken in this regard.
The NCC-PvPI produces the signal, which is preliminary in nature, based on the information on a possible causal relationship between an adverse event and a drug. Referring to the World Health Organisation's (WHO) definition, it adds that usually more than one report is required to generate a signal, depending on the seriousness of the event and the quality of the information.
According to the IPC, the signal is produced by the NCC-PvPI and presents information derived from the NCC-PvPI national ICSR database management system, that is, VigiFlow. This database contains a summary of case reports of suspected adverse drug reactions, submitted by adverse drug reaction Monitoring Centres (AMCs) across India.
PvPI Signal Review Panel assesses the database for the occurrence of signals of possible importance for public health, drug regulation, and science. The dissemination of identified signals by the PvPI is restricted to AMCs, regulatory authority staff, and their advisers participating in the pharmacovigilance programme of the country and the NCC has no responsibility for contacting all marketing authorisation holders.
The CDSCO and the IPC are responsible for deciding further action including communicating the information in Signal to relevant health professionals, and to the responsible market authorisation holders, within their jurisdictions.
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