| |OCTOBER 20258PHARMA LOBBY URGES CDSCO TO AMEND EXPORT REGULATIONNATCO PHARMA LAUNCHES BOSENTAN ORAL SUSPENSION IN US WITH 180-DAY EDGEManufacturers are being obliged to destroy stocks in order to comply with a new rule by the Central Drugs Standard Control Organization (CDSCO) that prohibits the export of pharmaceutical items with a shelf life of less than 60%. This regulation is causing enormous losses for the domestic industry.The industry asked the regulator to update the rule or take another approach during a recent discussion with CDSCO. The Federation of Pharma Entrepreneurs (FOPE), a lobby group for the pharmaceutical industry, also wrote to the regulator this week, urging it to overturn the rule that was put in place the previous year.FOPE president Harish Jain said that if importing countries are willing to accept such products, Indian exporters should not be impeded. In its letter, FOPE said that the requirement is causing a lot of loss by destroying stock.According to industry insiders, authorities would need a minimum of 60% shelf life at the time of shipment in order for a consignment to be cleared, for instance, if a medication made in August 2025 had an expiration date of July 2027. Following allegations that an Indian company had shipped illegal medication combinations to African countries like Ghana and Nigeria, the CDSCO revised its export NOC checklist. Since then, any medications meant for export must have regulatory approval.The regulation should be restricted to narcotics, opioid combinations, and other habit-forming substances, not to every class of drugs, including vitamins. They claimed the regulation was a major hurdle as export consignments are made-to-order with importing country identifiers, and could not be turned around for the domestic market leading them to destroy it all. The step was meant to prevent a recurrence of such events. PONATCO Pharma Limited has announced the launch of Bosentan tablets for oral suspension (TFOS), 32 mg, in the United States. The product is a generic equivalent to Tracleer, developed by Actelion Pharmaceuticals US, Inc. NATCO's launch partner is Lupin Limited. NATCO has the distinguished first-to-file status for this product, along with the associated 180 days of marketing exclusivity in the U.S. generic drug industry, which means they can be the only generic supplier of Bosentan TFOS during the initial launch period. That provides a tremendous competitive advantage. Bosentan TFOS is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in paediatric patients 3 years of age and older with idiopathic or congenital PAH. The therapy includes a reduction in pulmonary vascular resistance (PVR), which is expected to enhance the exercise capacity and quality of life in these patients. Bosentan TFOS will address an important unmet need in the care of paediatrics and provide identified treatment options for PAH in pediatrics.Bosentan tablets for oral suspension, 32 mg, are estimated to have generated approximately USD 10 million in annual sales in the U.S. during the 12 months ending June 2025, according to industry sales data. The launch is another step for NATCO to broaden its mark in niche generics generally, and in complex therapies specifically, which have barriers to entry.By partnering with Lupin, NATCO is further enhancing its marketing reach in the U.S. and increasing access to the therapy for patients. Given the exclusivity window and targeted entry into a developed market, NATCO should benefit from clinical research and commercial investment associated with the launch in the months ahead. POTOP STORIES
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