Sun Pharma Gets Relief on Packaging Norms for Pantoprazole-Levosulpiride FDC
New Delhi: In a regulatory relief to the company, the Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central Drugs Standard Control Organisation (CDSCO) has recommended the removal of a packaging and promotional condition earlier imposed on the fixed-dose combination (FDC) of Pantoprazole Sodium IP (Enteric coated pellets) 40 mg and Levosulpiride (SR tablets) 75 mg, marketed by Sun Pharma Laboratories Ltd.
The proposal was considered during the 07th SEC meeting held on 12th June 2025 at CDSCO headquarters in New Delhi. Sun Pharma referred to the condition imposed under Form 46 permission dated 27th January 2014, which stated that the FDC "shall be supplied in a Monocarton of 10 tablets per strip" and that "each pack, package insert and other promotional literature shall bear the statement: 'Indicated for short term treatment of GERD in adult patients who do not respond to PPI alone.'”
After detailed deliberation, the SEC recommended relaxation of the packaging requirement. As per the committee’s conclusion, “The committee agreed for the removal of above said condition.”
However, the SEC maintained that the indication disclaimer must continue to be prominently displayed. It stated, “The firm should print ‘indicated for short term treatment of GERD in adult patients who do not respond to PPI alone’ on all packing materials including strip and outer carton.”
The FDC of Pantoprazole, a proton pump inhibitor (PPI), and Levosulpiride, a prokinetic agent, is indicated for the treatment of gastroesophageal reflux disease (GERD), particularly in patients who do not respond adequately to PPIs alone. The updated recommendation provides manufacturers with greater flexibility in packaging formats while ensuring that therapeutic indications are clearly communicated to prescribers and patients.
