Hyderabad: Pulse Pharmaceuticals, a Hyderabad-based nano pharmaceutical drug delivery player, on Thursday said it has received approval from Drugs Controller General of India (DCGI) for its nano-carrier entrapped vitamin D3 oral dispersion delivery, marking a significant step in bringing nano drug-delivery research into a patient-ready product.The company said the approval followed stringent scientific evaluation and may be the first regulatory clearance globally for nanocarrier-based vitamin D3 delivery. The company has already been manufacturing the product using this technology for pharma giants such as Abbott and Sanofi for the Indian market.Pulse Pharmaceuticals founder and managing director KV Rambabu said the approval reflects India’s growing role in pharmaceutical innovation for global patients. He said the DCGI nod paves the way for the company to now apply for regulatory approval for the product globally, including the highly regulated markets like the US and Europe.Pulse said the technology is intended to improve bioavailability, tolerability and convenience for patients. The company is also applying its platforms to nutrients such as vitamin K2-7, vitamin B12 and iron, and common medicines including paracetamol, diclofenac and ibuprofen.Pulse said clinical studies showed the formulation delivered 50-60% higher serum vitamin D levels than conventional products. The company, which has been active in nano pharmaceutical drug delivery since 2010, developed the product using its proprietary Aqueol platform, designed to deliver lipophilic compounds effectively in water-based media.Pulse holds five granted patents across India, the United States, Russia, Mexico and Australia, with an EU patent for Aqueol in final approval stages. It is expanding in India, South-East Asia, Africa, the Middle East, Russia-CIS and Latin America, while exploring collaborations in the US and Europe.
