Drug Controller General of India Current Affairs - 2020

DCGI approves Serum Institute for Pneumococcal Polysacchride Conjugate Vaccine

On July 15, 2020, the Drug Controller General of India (DCGI) approved the first indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine. The vaccine was developed by Serum Institute of India. Highlights The DCGI has approved Serum Institute to conduct phase I, phase II and phase III clinical trials of Pneumococcal Polysaccharide conjugate vaccine in the country. Read More…

‘Itolizumab’ Injection gets DCGI Approval for Treatment of Moderate to Serve ARDS Patients

The Drug Controller General of India (DCGI) has given its approval to ‘Itolizumab’ injection for the treatment of COVID-19 patients with restricted emergency use only in case of moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients. DCGI has made it clear that written informed consent of the patient will be required by the authorities Read More…

Mylan gets DCGI Approval to launch its Generic Version of Remdesivir ‘DESREM’ at Rs 4800

Global pharmaceutical company Mylan N.V was given approval by the Drug Controller General of India (DCGI) for the launch of its generic version of Gilead Sciences Remdesivir drug for the treatment of COVID-19 positive patients in India. Mylan N.V is currently the second-largest company in the world for the manufacturing of generic and specialty pharmaceuticals. Read More…

Zydus Healthcare’s COVID-19 vaccine gets DCGI approval for Human Clinical Trials

On 2nd July 2020, the Drug Controller General of India (DCGI) has given approval for human clinical trials to Ahmedabad based Cadila Healthcare Limited (Zydus Healthcare). The permission is for the Phase-I and Phase-II clinical trials of the vaccine. Zydus Healthcare’s COVID-19 vaccine become the 2nd Indigenously developed vaccine to get the permission of the Read More…

ICMR fast-tracking efforts to launch ‘COVAXIN’ for public use by 15th August

In partnership with Hyderabad based Bharat Biotech, the Indian Council of Medical Research (ICMR) has selected 12 institutes for the Phase-I and Phase-II clinical trials of the first indigenously developed COVID-19 vaccine BBV152 (commonly known as COVAXIN). After successful completion of human clinical trials, the ICMR has set a target to launch the COVAXIN for Read More…