2-Deoxy-D-Glucose: A Ray of Hope in COVID Pandemic

Coronavirus disease-19 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 is a respiratory tract infection that has already made a huge negative impact in global health situation. Transmission mainly occurs through droplets, and the virus is highly contagious. Mainly symptomatic treatments are given at present with some drugs for serious patients with unproven efficacy and safety. In this context, Institute of Nuclear Medicine and Allied Sciences, a research laboratory of Defence Research and Development Organization in collaboration with Dr. Reddy’s Laboratories, Hyderabad, has introduced a new medicine named 2-Deoxy-d-glucose (2-DG) (which has been previously tried in cancer) for the treatment of seriously ill COVID patients with a target to reduce the oxygen demand. Clinical trials showed evidence that 2-DG effectively reduces oxygen requirement in seriously ill patients, and real-time polymerase chain reaction conversion is also faster. Recently, 2-DG is approved for the use in critically ill patients by the Drug Controller General of India in May 2021. The introduction of 2-DG brings a new hope in reducing the mortality in COVID patients.

Impact of new regulations on clinical trials in India.

Background: India is one of the major destination for conducting clinical trials. The Drug Controller General of India (DCGI) is the governing body responsible for all pharmaceutical-research and regulatory issues in India. While conducting clinical trials in India, regulations have come to ensure safety and wellbeing of the study subjects in the trial. The present study was planned to see the number of trials approved by DCGI and their trend over the last 8 years in view of new regulatory guidelines. Methods: Data obtained from website of the Regulatory Authority i.e. Central Drugs Standard Control Organization (CDSCO) regarding DGCI Approval of clinical trials from 2007 till 2014 are noted for analysis. Results: Total 1799 Trials Approved. 2007 had lowest approvals with 3 clinical trials & 2010 being highest with 500 trial approvals. Mean ± SD Approval of 224.88 ± 172.46 with Median rate of 206 per year was observed. Trend of Trials approved by DCGI shows sharp peak around 2008-2010 which follows sharp fall around 2013. Conclusion: The present study highlights the impact of these new regulations on Clinical Trials registered for approval of DCGI.