Zydus drug Virafin gets DCGI nod
The Drug Controller General of India recently provided “Restricted Emergency Use Approval” for the use of “Virafin”. Virafin is used to treat Hepatitis B and C. Now it is to be used to treat moderate COVID-19 infections.
- A single dose of Virafin during the early stage of infection, will help COVID-19 patients recover faster. Also, it will help to avoid complications.
- It will help to reduce the need for oxygen support.
- Virafin improves recovery time in moderate cases of COVID-19.
- According to Zydus 91.15% of adult patients treated with Virafin tested negative using RT-PCR in seven days.
Zydus is also working on COVID-19 Vaccine ZyCoV-D.
It is a DNA plasmid-based vaccine. In January 2021, the DGCI provided permission to conduct the Phase III trials of the vaccine. The trials are expected to be completed by May 2021.
It is a type of vaccine that is produced by transfecting antigen-coded DNA sequence into immunised cells. Transfection is the process of introducing purified nucleic acids into Eukaryotic cells.
Eukaryotes are organisms whose cell nucleus are enclosed in a nuclear envelope (called the nuclear membrane). On the other hand, prokaryotes are organisms that lack nuclear membrane around their nucleus.
Antigen is a toxin or foreign substance that induces an immune response in the body. These responses are usually in form of antibodies.
Drug Controller General of India
- The DCGI is the head of the Central Drugs Control Organisation.
- DGCI regulates medical and pharmaceutical devices.
- The DGCI establishes standards for manufacturing, import, sales and distribution of drugs in India.
- He makes sure if there is uniformity in the implementation of Drugs and Cosmetics Act.
- He issued licenses or medical devices that fall under Medical Devices Rules, 2017.