• Pune-based Gennova Biopharmaceuticals Ltd has received emergency use authorisation from the Drugs Controller General of India (DCGI) for its mRNA COVID-19 booster vaccine. 

• The company claimed that GEMCOVAC-OM is the first booster COVID-19 vaccine developed in India against the Omicron variant.

• It is delivered intra-dermally using a needle-free injection device system.

• It is a thermostable vaccine, which does not require ultra-cold chain infrastructure used for other approved mRNA-based vaccines, making it easy for deployment.

• The Department of Biotechnology (DBT) said that the vaccine was developed using the indigenous platform technology and supported under the Mission COVID Suraksha, implemented by Biotechnology Industry Research Assistance Council (BIRAC). 

What is mRNA vaccine?

• The premise of any vaccine is to induce a “memory” in the form of B and T cells. Upon any encounter with a pathogen (which can be bacteria or viruses), these cells will recognise the danger and fight it off by destroying the pathogen and pathogen-infected cells. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. 

• Not messenger RNA (mRNA) vaccines. Instead, they teach our cells how to make a protein — or even just a piece of a protein — that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.

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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