Indian regulations called the Materiovigilance Program of India (MvPI) to institutionalize post-marketing vigilance of medical devices to monitor patient safety throughout the country have been in place for a number of years. Under this program, a manufacturer, importer, distributor, healthcare professional, patient, or other entity can report an adverse event...
India Approves Allurion’s Gastric Balloon Device
India's regulator approved Allurion Technologies' swallowable, procedureless intragastric balloon used for losing weight. The Boston company has an Indian subsidiary in Hyderabad, India. Dr. Shantanu Gaur, founder of Allurion, together with his partner and former Harvard professor Dr. Ram Chuttani, developed a gastric pill balloon ("elipse") for weight loss. The balloon...
India’s Health Ministry Clears Two New Vaccines, Anti-Viral Drug
The Central Drugs Standard Control Organization (CDSCO), drug regulator for India's Health Ministry, approved two more Covid vaccines, Corbevax and Covovax, as also the anti-viral drug Molnupiravir to treat adult patients with COVID-19 as also those who have a high risk of progression of the disease. Corbevax: This vaccine is...
India Approves DNA Vaccine for Covid-19
Gujarat India based Zydus Cadila's Covid-19 vaccine ZyCoV-D, meant for adults and children aged 12 years and above, was today approved for "restricted use in emergency situation" by the Central Drugs Standard Control Organization (CDSCO) which is India's regulator. The DNA vaccine, developed in partnership with India's Department of Biotechnology,...
India to Streamline Regulatory Oversight of Medical Devices
India's Central Drugs Standard Control Organization (CDSCO), the national regulatory authority for drugs and medical devices, is now acting on a report submitted by the Drugs Technical Advisory Board (DTAB) — the country’s highest statutory decision-making body on technical matters related to medicines and medical devices. According to the proposal...
India Approves Abiomed's Impella Heart Pump
Danvers, MA-based Abiomed announced that the Impella 2.5, Impella CP and Impella 5.0 heart pumps received approval from India's Central Drugs Standard Control Organization for use during high-risk percutaneous coronary intervention, cardiogenic shock, and other reduced left ventricular function conditions. The first patient was treated with the Impella 2.5 heart...