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 Approves Nasal Covid-19 Vaccine
The Drug Controller General of India authorized the country’s first nasal spray vaccine "under Restricted Use in Emergency Situations for ages 18 and above," marking a big step toward increasing the availability of needle-free vaccines around the world. Washington University St. Louis, which had created and developed the recombinant adenoviral...
India’s Biotech Startup Eyestem Raises $6.4 Mn
Headquartered in Bangalore and Delaware, cell therapy startup Eyestem secured $6.4 million in its Series A funding round at a post-money valuation of $46.4 million. The funding was led by three Indian pharma majors- Biological E. Limited, Alkem, NATCO and Anurag and Karan Bagaria, promoters of Kemwell Biopharma. Existing investors...
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,...