The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre for the Pharmacovigilance Programme of India (PvPI), has recommended to the Central Drugs Standard Control Organisation (CDSCO) for regulatory actions against 24 drugs which have been found to show adverse drug reactions (ADRs).  

According to sources, the India specific drug safety signals, drug alerts and others have been identified from the reported ADRs by the Signal Review Panel (SRP) of the PvPI and has recommended to the CDSCO for the appropriate regulatory actions against the list of 24 suspected drugs.  

Among these drugs, Carbamazepine shows the ADR of Stevens Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The PvPI has recommended to the CDSCO for drug safety label change – patient may be screened for HLAB 1502 prior to initiating the carbamazepine treatment. On this recommendation, the CDSCO has issued an order to all MAHs to comply the same.  Mannitol is showing the ADR of Hypokalaemia, and the PvPI has recommended to include in Prescribing Information which is in process now.  

Piperacillin and Tazobactam have shown the ADR of Hypokalaemia, Bronchospasm and the PvPI has recommended to the CDSCO to include in Prescribing Information. The CDSCO has issued an order to all MAHs to comply the same.   

Azithromycin, Cefixime and Cloxacillin have shown ADR of Acute Generalised Exanthematosus Pustulosis (AGEP) and PvPI has recommended to the CDSCO to include in Prescribing Information which is in process now.   

Other drugs in the list include Rota Vaccine (Intussusception), Ranitidine (Cardiac Arrest), Anti-Rabies Vaccine (Erythema Multiforme), Pulmonary Surfactant (Pulmonary Haemorrhage), Ceftriaxone (Stevens Johnson syndrome), Lamotrigine (Stevens Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)), Betamethasone (Photosensitivity Reaction), Itraconazole (Photosensitivity reaction), Ibuprofen (Stevens Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)), Amoxicillin/ Clavulanate Potassium (Stevens Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)), Ciprofloxacin (Stevens Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)), Sodium Valproate (Gum Hyperplasia), BCG vaccine (Lymphadenopathy), Docetaxel (Candidiasis), Furosemide (Dermatitis Lichenoid), Itraconazole (Acute Generalised Exanthematosus Pustulosis (AGEP)), Lithium Carbonate (Drug Reaction with Eosinophilia and Systemic symptoms Syndrome (DRESS)),  and Phenytoin (Acute Generalised Exanthematosus Pustulosis (AGEP)).