Drug Controller General of India (DCGI) has given approval for human clinical trials of COVAXIN, the first potential COVID-19 Vaccine developed in India. The potential vaccine has been developed by Hyderabad-based Bharat Biotech, in association with Indian Council for Medical Research (ICMR). Human Trials for Phase I and Phase II are scheduled to start across the country from next month.
Gplife Healthcare Pvt. Ltd. And it’s associate company Shadow Pharma Venture Pvt. Ltd today announced that Gplife Healthcare has obtained Phase II clinical trial permission on ACT 12 Tablets and ACT 13 Dry Syrup for the treatment of COVID 19 positive hospitalized patients. Treatment duration for patients will be 10 days. The results of clinical trial are expected by August 2020. Both products have been found safe at the recommended dose for Phase II study.
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU.
Hetero, one of India’s leading generic pharmaceutical companies, announced today that it has received the manufacturing and marketing approval for the investigational antiviral medicine ‘Remdesivir’ from the Drug Controller General of India (DCGI) for the treatment of Covid-19. Hetero’s generic version of Remdesivir will be marketed under the brand name ‘COVIFOR’ in India.
Amidst ever-increasing cases of coronavirus, efforts are being made to speed up testing of suspects of COVID-19 carriers, especially in the interior parts of the country. In one such initiative, a mobile diagnostic unit I-Lab (Infectious disease diagnostic lab) has been launched on Thursday by Dr. Harsh Vardhan, Minister of Science and Technology, Health and Family Welfare and Earth Sciences. The I-Lab is expected to help in the expansion of COVID-19 testing in remote areas.
Accurate testing is important to get out of the clutches of novel coronavirus. Steeping up efforts in this regard, the Indian Institute of Technology (IIT) Guwahati, in association with RR Animal Healthcare Ltd and Guwahati Medical College and Hospital (GMCH), has developed low-cost diagnostic kits. These are Viral Transport Media (VTM) kits, RT-PCR kits, and RNA isolation kits. Himanta Biswa Sarma, the Minister of Finance, Health and Family Welfare, Assam, launched the VTM kits.
The Central Drug Research Institute (CDRI), Lucknow, has received permission from Drug Controller General of India (DCGI) for carrying out Phase III clinical trials to test the efficacy, safety and tolerability of the antiviral drug Umifenovir. The Phase III activities will be carried out at King George's Medical University (KGMU), Dr Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and ERA's Lucknow Medical College and Hospital, Lucknow.
New modelling research, published in The Lancet Infectious Diseases journal, suggests the coronavirus (SARS-CoV-2) that causes COVID-19 may spread more easily among people living together and family members than severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS). The estimates are the first of their kind to quantify symptomless transmission.
The NIHR-funded and supported study RECOVERY (Randomised Evaluation of COVid-19 thERapY) has today announced that the steroid dexamethasone has been identified as the first drug to improve survival rates in certain coronavirus patients.