• The Drugs Controller General of India (DCGI) has granted restricted emergency use authorisation for Biological E’s COVID-19 vaccine Corbevax for those aged five to 12 years and Bharat Biotech’s Covaxin for children in the age group of six to 12 years.

• The DCGI has also granted emergency use authorisation (EUA) to Cadila for its ZyCoV-D for an additional dose of 3mg with a two-jab inoculation schedule 28 days apart for those aged above 12 years. ZyCoV-D is, currently, approved for a 2mg three-dose vaccination schedule.

• The DCGI approval comes following recommendations by the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO).

• The SEC had last week reviewed the application of Biological E and Bharat Biotech seeking emergency use authorisation for Corbevax and Covaxin for use in children of five to 12 years and six to 12 years age group, respectively. It also reviewed Cadila's application.

• Biological E’s Corbevax is being used to inoculate children against COVID-19 in the age group of 12 to 14 years. Covaxin has been granted Emergency Use Listing (EUL) by the DCGI for the age group of 12 to 18 years on December 24, 2021.

• India began inoculating children aged 12-14 years on March 16. 

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).

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