CDSCO publishes list of approved COVID-19 vaccines in India

June 18, 2022 by API FIRST
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18 June, 2022

 

Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency of Government of India has published the list of all the vaccines approved in India for the prophylaxis of Covid-19. The data consists of all the important details of the Covid-19 vaccines viz. name of vaccine, name of manufacturer/ importer, date of approval,  age group, dosing schedule, route, storage conditions and current shelf life.

 

The list of approved vaccines are as follows:

 

A. COVID-19 vaccines approved for Manufacture for Sale or for Distribution in India 

S. No.VaccineApplicantDate of approvalAge groupDosing scheduleRoute & StorageShelf Life as on 15.06.2022
1ChAdOx1 nCoV-19 Corona Virus vaccine Recombinant) (COVISHIELD)M/s Serum Institute of India Pvt. Ltd.27.01.2022≥ 18 yearsTwo doses, 4 to 6 weeks apart (Overseas Data available for 12 weeks)Intramuscular, 2-8°C9 months
2Whole-Virion Inactivated SARS- CoV-2 Vaccine
(COVAXIN)
M/s Bharat Biotech27.01.2022≥ 18 yearsTwo doses, Day 0 & 28Intramuscular, 2-8°C12 months

Note: Both COVISHIELD & COVAXIN vaccines were initially approved for Restricted Use in Emergency Situation in the country on 03.01.2021

 

B. COVID-19 vaccines approved for Restricted Use in Emergency Situation in India

Sr. NoVaccineApplicantDate of approvalAge groupDosing scheduleRoute & StorageShelf Life as on 15.06.22
1Gam COVID Vac (component I & II) (SPUTNIK-V)M/s Dr. Reddy’s Lab. Ltd. (Importer)12.04.2021≥ 18 yearsTwo doses,
Day 0 (comp I) & Day 21 (comp II)
Intramuscular, -18°C12 months
2mRNA-1273COVID-19 vaccine
(Moderna vaccine)
M/s Cipla Ltd. (Importer)29.06.2021≥ 18 yearsTwo doses, Day 0 & 28Intramuscular, -25°C to -15°C7 months
3Gam COVID Vac (component I & II) (SPUTNIK-V)M/s Panacea Biotec Ltd02.07.2021≥ 18 yearsTwo doses,
Day 0 (comp I) & Day 21 (comp II)
Intramuscular, -18°C12 months
4COVID-19 vaccine (Ad26.COV2-S) [recombinant]
(Janssen Vaccine)
M/s Johnson & Johnson Pvt. Ltd.
(Importer)
07.08.2021≥ 18 yearsSingle doseIntramuscular, -25°C to -15°C and 2 to 8°C6 months
5COVID-19 vaccine (Ad26.COV2-S)[recombinant]
(Janssen Vaccine)
M/s Biological E Limited18.08.2021≥ 18 yearsSingle doseIntramuscular, -25°C to -15°C and 2 to 8°C6 months
6Novel Corona Virus-2019-nCov vaccine (rDNA)
(ZyCoV-D)
M/s Cadila Healthcare Limited20.08.2021≥ 12 yearsThree doses Day 0, 28 & 56Intradermal, 2-8°C9 months
7Gam COVID Vac (component I & II) (SPUTNIK-V)M/s Hetero Biopharma Ltd07.10.2021≥ 18 yearsTwo doses, Day 0 (comp I) & Day 21 (comp II)Intramuscular, -18°C6 months
8Whole-Virion Inactivated SARS- CoV-2 Vaccine
(COVAXIN)
M/s Bharat Biotech24.12.2021≥ 12 to 18 yearsTwo doses, Day 0 & 28Intramuscular, 2-8°C12 months
26.04.2022>6 to <12 years
9SARS-CoV-2 vaccine containing Receptor Binding Domain (RBD) of SARS-CoV-2 gene
(CORBEVAX)
M/s Biological E Limited28.12.2021≥ 18 yearsTwo doses, Day 0 & 28Intramuscular, 2-8°C12 months
21.02.2022≥ 12 years
26.04.2022≥5 to <12 years
10SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine
[COVOVAX]
M/s Serum Institute of India Pvt. Ltd.28.12.2021≥ 18 yearsTwo doses, Day 0 & 21Intramuscular, 2-8°C6 months
08.03.2022≥ 12 years
11Recombinant adenoviral vector vaccine containing particles of serotype 26 containing the protein S gene of the SARS-CoV-2 virus
(SPUTNIK Light)
M/s Dr. Reddy’s Lab. Ltd. (Importer)05.02.2022≥ 18 yearsSingle doseIntramuscular, -18°C6 months
12Recombinant adenoviral vector vaccine containing particles of serotype 26 containing the protein S gene of the SARS-CoV-2 virus
(SPUTNIK Light)
M/s Hetero Biopharma Ltd16.03.2022≥ 18 yearsSingle doseIntramuscular, -18°C6 months
13Novel Corona Virus-2019-nCov vaccine (rDNA)
(ZyCoV-D)
M/s Cadila Healthcare Limited26.04.2022≥ 12 yearsTwo doses, Day 0 & 28Intradermal, 2-8°C9 months
14Lyophilized mRNA vaccine for injection (COVID-19)
[HGCO-19]
M/s Gennova Biopharmaceuticals Limited28.06.2022≥ 18 yearsTwo doses, Day 0 & 28Intramuscular, 2-8°C6 months

 

Previously also, we had informed you regarding the grant of restricted EUA to vaccinate children by CDSCO in India.

 

The complete notification can be read here.

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API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India.