• The Drugs Controller General of India (DCGI) has granted restricted emergency use authorisation (EUA) to Biological E’s COVID-19 vaccine Corbevax for the 12 to 18 years age group, subject to certain conditions.

• However, the government has not taken a decision yet on vaccinating those aged below 15 years.

• This is the third vaccine to have received EUA from the DCGI for the age group of 12-18 years after Zydus Cadila’s ZyCoV-D and Bharat Biotech’s Covaxin.

• At present, India is using Covaxin to vaccinate adolescents in the 15 to 18 years age group.

Corbevax vaccine

• Corbevax is India’s first indigenously developed Receptor Binding Domain (RBD) protein sub-unit vaccine for COVID-19.

• It has been designed using a similar technology used for developing Hepatitis B vaccines.

• The vaccine has been developed by Hyderabad-based firm Biological E. Limited in collaboration with Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) in Houston, Texas.

• It received the DCGI approval for Emergency Use Authorization (EUA) in December 2021.

• However, it has not been included in the country’s vaccination drive.

• The DCGI’s approval comes after the Subject Expert Committee on COVID-19 of the CDSCO on February 14 recommended granting restricted EUA to Corbevax for the 12 to 18 years age group after deliberating on Biological E’s application.

• The Corbevax vaccine is administered through the intramuscular route with two doses scheduled 28 days apart and is stored at 2-8 degrees Celsius temperatures and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack.

What is the role of DCGI?

• The Central Drugs Standard Control Organisation (CDSCO) headed by the Drugs Controller General (India) is the central authority for regulating the quality of drugs marketed in the country under the Drugs and Cosmetics Act, 1940. 

• The mission of CDSCO is to safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.

• Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority are major functions of CDSCO.

• The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 have entrusted various responsibilities to central and state regulators for regulation of drugs and cosmetics. It envisages uniform implementation of the provisions of the Act and Rules made there under for ensuring the safety, rights and well being of the patients by regulating the drugs and cosmetics. 

• CDSCO is constantly striving to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.

• The CDSCO, with its headquarters in New Delhi has six zonal offices, six  sub-zonal offices, seven Central Drugs Testing Laboratories and nine airport & 18 sea port Offices (Including Inland Container Depots). 

Manorama Yearbook app is now available on Google Play Store and iOS App Store