Hyperfine Inc., a health technology company based in Guilford, CT, has secured regulatory approval from India’s Central Drugs Standard Control Organization (CDSCO) for its Swoop system (depicted below). This authorization allows for the commercialization of the portable, ultra-low-field, AI-powered, magnetic resonance brain imaging system capable of providing imaging at multiple...
India’s CDSCO to Enhance Quality Oversight for Nutraceuticals
At the Indian Pharmaceutical Alliance's (IPA) 9th Global Pharmaceutical Quality Summit, held in Mumbai in 2024, India's Central Drugs Standard Control Organization (CDSCO) Drugs Controller General, Rajeev Raghuvanshi spoke about the efforts to strengthen quality oversight in India. He addressed: regulatory non-compliance and quality issues capacity building projects in the...
India Strengthens Its Regulatory Framework for Pharma and Med Devices
India's Federal Minister for Health, JP Nadda, has called for the development of a world-class regulatory framework for drugs, cosmetics, and medical devices to align with the country's reputation as the 'Pharmacy of the World'. This initiative aims to elevate India's regulatory standards to global levels, reflecting its significant role...
Boehringer Ingelheim Launches Parasite Protection Products in India
Boehringer Ingelheim, a global leader in animal health, has launched NexGard SPECTRA® (afoxolaner and milbemycin oxime) in India after approval from the Central Drugs Standard Control Organisation. This represents an expansion of their successful NexGard® product line for dogs aged two months and above, weighing at least one pound. NexGard...
Thermo Fisher, India’s Mylab Collaborate on Test Kits
Waltham, MA -based Thermo Fisher Scientific, which has facilities in Bangalore, partnered with Pune-based startup Mylab Discovery Solutions to source RT- PCR kits for infectious diseases. Some of the kits developed by Mylab have already received licensing rights from India's regulatory body, the Central Drugs Standard Control Organization. Mylab’s portfolio...
AstraZeneca’s Biliary Tract Cancer Drug Receives Regulatory Approval in India
British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca PLC's India arm announced that it received additional indication approval from the Central Drugs Standard Control Organization (CDSCO) for the drug Durvalumab to treat biliary tract cancer (BTC) in India. BTC is a group of rare and aggressive gastrointestinal cancers that form in the...