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...
Sanofi Gets Approval to Market its Med Device in India
Sanofi India has received marketing approval from India's Central Drugs Standard Control Organization (CDSCO) for its diabetes drug Soliqua (in pre-filled pen). Soliqua is indicated as an adjunct treatment to improve glycemic control through diet and exercise in adults with obesity and type 2 diabetes who are inadequately controlled on...
India’s Government Considers a Proposal to Allow Hospitals to Source Med Devices from Manufacturers
The Federal government of India will deliberate and take a decision on whether large hospitals should be allowed to import medical devices directly from the manufacturers. Currently, governmental rules stipulate that an import license is required to procure medical devices from original equipment manufacturers. However, there is no mention in...
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...