iNCOVACC Gets DCGI Nod for Restricted Emergency Use 

  • IASbaba
  • September 8, 2022
  • 0
Science and Technology
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In News: The national drug regulator, DGCI, has given the green signal to the country’s first intra-nasal Covid vaccine for emergency use in adults – iNCOVACC.

  • Manufactured by Bharat Biotech, the company behind Covaxin, in partnership with Washington University-St Louis, and partly funded by the Department of Biotechnology’s Covid Suraksha programme
  • The new vaccine has been approved for primary immunisation — it can be administered only to the unimmunised.
  • Those who have already received the first and second doses of other vaccines will not be eligible to get iNCOVACC as the “precaution” third dose.

Source: Bharat Biotech

The Administration

  • Will be delivered through the nasal route.
  • This would potentially trigger an immune response in the mucosal membrane.
  • It has been designed to not only protect against infection but also reduce transmission of the virus.
  • May produce local antibodies in the upper respiratory tract, which may provide the potential to reduce infection and transmission.
  • The vaccine uses a modified chimpanzee adenovirus, which cannot replicate in the body, to carry the Covid spike protein to induce immunity.

Benefits of intranasal vaccine

  • Promises to be more effective, since it is expected to generate immune responses at the site of infection (respiratory mucosa)
  • Non-invasive, Needle-free.
  • Ease of administration – does not require trained health care workers.
  • Elimination of needle-associated risks (injuries and infections).
  • High compliance (Ideally suits for children’s and adults).
  • Scalable manufacturing – able to meet global demand. It can produce 100 million doses a month.

India’s Progress Card

  • India has, so far, administered a total of 213 crore vaccine doses, of which 102 crore are first doses
  • Nearly 98 per cent of adults in India had received at least one dose by the third week of July
  • Currently, Covishield, Covaxin and Corbevax are part of the Government’s Covid immunisation drive while vaccines like Covovax and Sputnik are available at private centres.

About Drugs Controller General of India

  • Drugs Controller General of India is the head of department of the Central Drugs Standard Control Organization of the Government of India.
  • Responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India
  • DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
  • Comes under the Ministry of Health & Family Welfare.
  • DCGI lays down the standard and quality of manufacturing, selling, import and distribution of drugs in India.
  • Acting as appellate authority in case of any dispute regarding the quality of drugs
  • Preparation and maintenance of national reference standard
  • To bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
  • DCGI also act as Central Licensing Authority (CLA) for the medical devices which fall under the purview of Medical Device Rules 2017

Source: The Indian Express

Previous Year Question

Q.1) In the context of vaccines manufactured to prevent COVID-19 pandemic, consider the following statements: (2022)

  1. The Serum Institute of India produced COVID-19 vaccine named Covishield using mRNA platform.
  2. Sputnik V vaccine is manufactured using vector based platform.
  3. COVAXIN is an inactivated pathogen based vaccine.

Which of the statements given above are correct?

  1. 1 and 2 only
  2. 2 and 3 only
  3. 1 and 3 only
  4. 1, 2 and 3

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