Miraqules MedSolutions’s StopBleed Receives Class C Approval from CDSCO 

Key Highlights: 

• Spinout startup Miraqules MedSolutions from NIT Rourkela has received regulatory approval from the Central Drugs Standard Control Organisation for the commercial manufacturing and clinical deployment of its rapid haemorrhage control product, StopBleed, classified as a Class C medical device. 

• Designed for trauma and emergency situations such as road accidents, gunshot wounds, blast injuries, and industrial trauma, StopBleed is available in powder and pellet forms and uses nanofibrous aggregate technology to absorb plasma, trap blood cells, and accelerate clot formation to quickly seal wounds. With a three-year shelf life at room temperature, the solution can be used by healthcare professionals as well as trained first responders in both urban and remote settings. 

• The technology was developed and patented at NIT Rourkela by Prof. Devendra Verma and researcher Sabir Hussain before being transferred to Miraqules MedSolutions for manufacturing and commercialization. Following laboratory validation under ISO 10993 standards and clinical evaluation in collaboration with Sanjay Gandhi Institute of Trauma and Orthopedics, the company has begun limited deployment while exploring distribution partnerships to scale access across India’s emergency care ecosystem. 

Implications:  

StopBleed fills critical gap in India’s trauma response, handing emergency teams a game-changing tool that slashes preventable bleeding deaths across highways and factories. 
Academic-to-market success pressures imported haemostats while Miraqules hunts distribution partners to blanket ambulances and rural clinics. 
Made-in-India innovation accelerates emergency medtech adoption, positioning trauma control as next high-volume consumable for hospitals nationwide. 

Source: Expresspharma