Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

Vaccines

S.no Title Release Date Download Pdf Pdf Size
S.no Title Release Date Download Pdf Pdf Size
1 COVID-19 vaccines approved in the country as on 04.10.2022 2022-Oct-04 96 KB
2 COVID-19 vaccines approved in the country 2022-Jul-08 300 KB
3 Month wise Tentative Schedule of SEC (Vaccine) meetings of the Year 2022 2022-Feb-17 10 KB
4 SOP Guidance for import of vaccine by private sector or any person 2021-May-04 7 KB
5 Month wise Tentative schedule of SEC (Vaccine) meetings of the year 2021 2021-Jan-01 182 KB
6 List of approved veterinary vaccines 2021-Dec-02 1138 KB
7 Cancellation of Registration Certificate No. SVH-9 and Import License SVH-9-131 2019-Apr-01 2894 KB
8 Cancellation of Registration Certificate No. SVH-101 and Import License SVH-101-112 2019-Apr-01 3016 KB
9 List of meetings of Expert Committee for examination of vaccine PSUR 2018-Feb-09 7KB
10 Notice regarding Online application for Human Vaccines on Sugam 2017-Feb-06 271KB
11 Presentation for Rabies Vaccine 2016-Sep-08 219KB
12 Notice regarding Preparation for global switch from tOPV to bOPV, 2016 2016-Mar-23 174KB
13 Office Memorandum: Timeline for CDL Kasauli to review and processing of applications referred for CMC or post appoval change 2016-Dec-13 270KB
S.no Title Release Date Download Pdf Pdf Size
1 Guidance for Industry for Post approval changes in biological products Quality safety and Efficacy Documents 2020-Jan-03 704 KB
S.no Title Release Date Download Pdf Pdf Size
1 SmPC, factsheet & PI of Incovacc (Nasal) vaccine of Ms Bharat Biotech for age 18 years and above 2022-Sep-09 1014 KB
2 SmPC & factsheet of COVOVAX of M/s Serum for age 7 years and above 2022-Jul-25 609 KB
3 SmPC & factsheet of CORBEVAX of M/s Biological E for age 5 years and above 2022-Jul-22 1003 KB
4 SmPC & factsheet of COVOVAX of M/s Serum for age 12 years and above 2022-Jul-22 2909 KB
5 SmPC & factsheet of COVAXIN vaccine of M/s Bharat Biotech for age 6 years and above 2022-Jul-22 8276 KB
6 SmPC & factsheet of ZyCoV-D (3 mg) vaccine of M/s Cadila for age 12 years and above 2022-Jul-22 887 KB
7 SmPC & factsheet of Sputnik Light vaccine of M/s Dr. Reddy's Lab. for age 18 years and above 2022-Jul-22 649 KB
8 SmPC & factsheet of Gemcovac vaccine of M/s Gennova for age 18 years and above 2022-Jul-22 339 KB
9 Factsheet of Corbevax vaccine manufactured by M/s Biological E 2022-Jan-19 265 KB
10 SmPC of Corbevax vaccine manufactured by M/s Biological E 2022-Jan-18 636 KB
11 ZyCoV-D vaccine of M/s Cadila 2022-Feb-03 311 KB
12 COVAXIN (Adults & adolescents) of M/s Bharat Biotechv 2022-Feb-02 11612 KB
13 SmPC & factsheet of CORBEVAX of M/s Biological E 2022-Feb-02 3605 KB
14 SmPC & factsheet of COVOVAX of M/s Serum 2022-Feb-02 498 kb
15 SmPC & factsheet of Janssen vaccine of M/s Johnson & Johnson 2022-Feb-02 329 KB
16 SmPC & PI of Measles and Rubella Vaccine Live I.P. of M/s Serum 2022-Dec-06 249 KB
17 Factsheet of Gam-COVID-Vac Combined vector vaccine (Component I & II) SPUTNIK V of Dr. Reddy's Laboratories Ltd 2021-May-23 616 KB
18 SmPC of Gam-COVID-Vac Combined vector vaccine (Component I & II) SPUTNIK V of Dr. Reddy's Laboratories Ltd 2021-May-23 292 KB
19 Factsheet of ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) of M/s Serum Institute of India approved for restricted use in emergency situation 2021-Mar-31 142 KB
20 SmPC and PI of ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) of M/s Serum Institute of India approved for restricted use in emergency situation 2021-Mar-24 2781 KB
21 Factsheet and Consent Form of Inactivated Corona virus Vaccine of M/s Bharat Biotech approved for restricted use in emergency situation in Clinical trial mode 2021-Mar-22 123 KB
22 SmPC & PI of Whole Virion Inactivated Corona Virus Vaccine of M/s Bharat Biotech approved for restricted use in emergency situation in Clinical Trial Mode 2021-Mar-22 202 KB
23 SmPC of Whole Virion Inactivated Corona Virus Vaccine of Ms Bharat Biotech 2021-Jan-15 202 KB
24 SmPC of ChAdOx1 nCoV- 19 CORONA VIRUS VACCINE (RECOMBINANT) of M/s Serum Institute of India 2021-Jan-15 2781 KB
25 Factsheet of ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) of M/s Serum Institute of India approved for restricted use in emergency situation August 2021 2021-Aug-13 1848 KB
26 Biomed - Rabies vaccine 2019-Mar-12 117 KB
27 Cadila Healthcare Tetanus Vaccine 2017-Feb-17 94 KB
28 Cadila Healthcare Varicella Vaccine 2017-Feb-17 75 KB
29 Cadila Healthcare- VaxiRab N (PCECV) 2017-Feb-17 1400 KB
30 Cadila-Monovalent H1N1-09 VLP Vaccine 2017-Feb-17 1734 KB
31 Cadila- Trivalent Influenzae Vaccine 2017-Feb-17 988 KB
32 Dano-Tetanus Toxoid 2017-Feb-17 2516 KB
33 GSK-Boostrix 2017-Feb-17 117 KB
34 GSK-Cervarix 2017-Feb-17 159 KB
35 GSK-EngerixB Ped & Adult 2017-Feb-17 134 KB
36 GSK-FLuarix 2017-Feb-17 140 KB
37 GSK-Havrix 1440 & 720 2017-Feb-17 96 KB
38 GSK-Poliorix 2017-Feb-17 50 KB
39 GSKPriorix 2017-Feb-17 121 KB
40 GSK-Priorix Tetra 2017-Feb-17 155 KB
41 GSK-Rotarix Lyo 2017-Feb-17 353 KB
42 GSK-Synflorix 2017-Feb-17 244 KB
43 GSK-Twinrix Adult 2017-Feb-17 82 KB
44 GSK-Varilrix 2017-Feb-17 103 KB
45 HLL-DTP-Hib-Hep 2017-Feb-17 3307 KB
46 Hll-Hepatitis B Vaccine 2017-Feb-17 2053 KB
47 Human Biologicals- Rabies vaccine Human I_P 2017-Feb-17 3663 KB
48 JE Biological E Ltd JE SPC 2017-Feb-17 113 KB
49 Man Mill Inactivated Influenza Vaccine 2017-Feb-17 167 KB
50 MSD- Pneumococcal Vaccine Pneumovax 2017-Feb-17 216 KB
51 MSD- qHPV Vaccine Gardasil 2017-Feb-17 339 KB
52 MSD - Rotavirus Vaccine Rotateq 2017-Feb-17 357 KB
53 MSD-Varicella Vaccine Variped 2017-Feb-17 246 KB
54 Bharat Biotech -Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b 2017-Feb-17 65 KB
55 MSD - Zoster Vaccine Zostavax 2017-Feb-17 286 KB
56 Novartis- Influenza vaccine 2017-Feb-17 3163 KB
57 Novartis-Menveo 2017-Feb-17 2657 KB
58 Novartis -Quinvaxem 2017-Feb-17 2283 KB
59 Novomedi-Live Varicella Vaccine 2017-Feb-17 4146 KB
60 Panacea Biotec Easy Four-TT 2017-Feb-17 1945 KB
61 Panacea Biotec Polio Vaccine, Live Oral 2017-Feb-17 62 KB
62 Panacea-bOPV-P T BioFarma 2017-Feb-17 47 KB
63 Panacea-Bopv Sanofi Pasteur 2017-Feb-17 52 KB
64 Panacea- DTwP 2017-Feb-17 118 KB
65 Panacea- Easyfive Baddi-50L 2017-Feb-17 110 KB
66 Pfizer-Prevenar13 2017-Feb-17 564 KB
67 Prosper Chaneel - Rabies 2017-Feb-17 1620 KB
68 Sanofi- Hexaxim Vaccine 2017-Feb-17 3262 KB
69 sanofi Menactra-SMPC 2017-Feb-17 96 KB
70 Serum - Influenzae Vaccine 2017-Feb-17 2092 KB
71 MSD_Zoster vaccine India PI 1 2017-Feb-17 241 KB
72 Bharat Biotech-Human Inactivated Influenza A(H1N1) Virus Vaccine (Adsorbed) 2017-Feb-17 71 KB
73 Bharat- Biotech-JE Vaccine 2017-Feb-17 155 KB
74 Bharat Biotech- Purified, Inactivated, Lyophilized Rabies Vaccine, Prepared on Vero Cells 2017-Feb-17 168 KB
75 Bharat Biotech- Rabies vaccine Thiomersol free 2017-Feb-17 594 KB
76 Bharat Biotech-Rotavirus vaccine (Live Attenuated, Oral) 2017-Feb-17 144 KB
77 Bharat Biotec- Trivalent Poliomyelitis Vaccine Type 1, Type 2 and Type 3, Live (Oral). tOPV 2017-Feb-17 65 KB
78 Bharat-TTyphoid (Vi Capsular Polysaccharide)-Tetanus Toxoid Conjugate Vaccine 2017-Feb-17 189 KB
79 BIBCOL-Bivalent Poliomyelitis Vaccine 2017-Feb-17 1288 KB
80 BIBCOL-Trivalent OPV 2017-Feb-17 1075 KB
81 Biological E - DTP Vaccine 2017-Feb-17 820 KB
82 Biological E- DTwP vaccine 2017-Feb-17 3775 KB
83 Biological E - Hepatitis B Vaccine 2017-Feb-17 779 KB
84 Biological E. Ltd Liquid Pentavalent SPC 2017-Feb-17 2132 KB
85 Biological E. Ltd Recon Pentavalent SPC 2017-Feb-17 2759 KB
86 Biological E - Td Vaccine 2017-Feb-17 706 KB
87 Biological E - TT Vaccine 2017-Feb-17 843 KB
88 Biomed -bOPV 2017-Feb-17 1279 KB
89 Biomed - tOPV 2017-Feb-17 1316 KB
90 Biomed - Typhoid Polysaccharide Vaccine I_P 2017-Feb-17 1169 KB
91 Cadila Healthcare - Diphtheria, Tetanus and Pertussis Vaccine 2017-Feb-17 91 KB
92 Cadila Healthcare-H1N1 2017-Feb-17 77 KB
93 Cadila Healthcare - Inactivated Tetravalent Influenza Vaccine 2017-Feb-17 81 KB
94 Cadila HealthcareInactivated Trivalent Influenza Vaccine 2017-Feb-17 80 KB
95 Cadila Healthcare Measles, Mumps and Rubella Vaccine 2017-Feb-17 72 KB
96 Cadila Healthcare - Measles vaccine 2017-Feb-17 81 KB
S.no Title Release Date Download Pdf Pdf Size
1 Details of manufacturing permissions of Human Vaccines approved by CDSCO 2009 - 6th Oct. 2022 2022-Oct-06 235 KB
S.no Title Release Date Download Pdf Pdf Size
1 Details of Import Permissions of Human Vaccines approved by CDSCO (2009 - 6th Oct. 2022 2022-Oct-06 125 KB
2 Status of Import Licenses (Form 10) of Human Vaccine & Recombinant Products, Issued from 01/01/2020 to 30/09/2020 2020-Dec-10 9086 KB
3 Status of Registration Certificate (Form 41) of Human Vaccine & Recombinant Products Issued from 011/01/2020 to 30/09/2020 2020-Dec-10 7146 KB
4 Status of Import Licenses (Form 10) of Human Vaccine & Recombinant Products, Issued from 01/01/2019 to 31/12/2019 2020-Apr-27 94 KB
5 Status of Registration Certificate (Form 41) of Human Vaccine & Recombinant Products Issued from 01/01/2019 to 31/12/2019 2020-Apr-27 99 KB
6 Status of Import License (Form 10) of Recombinant Products, Human and Veterinary Vaccines issued from 01/01/2018 to 31/12/2018 2019-Feb-07 8069 KB
7 Status of Registration Certificate (Form 41) of Recombinant Products, Human and Veterinary Vaccine issued from 01/01/2018 to 31/12/2018 2019-Feb-06 4641 KB
8 Status of Registration Certificate (Form 41) of Recombinant Products, Human and Veterinary Vaccine issued from 01/01/2017 to 31/12/2017 2018-Jan-03 339 KB
9 Status of Import License (Form 10) of Recombinant Products, Human and Veterinary Vaccines issued from 01/01/2017 to 31/12/2017 2018-Jan-02 375 KB
S.no Title Release Date Download Pdf Pdf Size
1 Tentative Central Inspection Plan for Clinical Trial Inspection (Vaccine) for year -2023 2023-Jan-31 186 KB
2 CIP Using Risk Based Approach of Vaccine manufacturing Units for the year 2023 in the CDSCO 2023-Jan-03 375 KB
3 CIP Using Risk Based Approach of r-DNA Manufacturing Units for 2020 2020-Aug-25 1622 KB
4 CIP Using Risk Based Approach of Vaccine manufacturing Units for the year 2020 2020-Aug-25 2260 KB
5 List of rDNA Clinical trials to be Inspected as per the Central Inspection Plan-2019 2019-May-20 85 KB
6 Central Inspection Plan Using Risk Based Approach of r-DNA products Manufacturing Units for 2019 QA-INS-012 2019-May-20 2851 KB
7 List of Vaccine Clinical trials to be Inspected as per the Central Inspection Plan-2019 2019-May-20 56 KB
8 Central Inspection Plan Using Risk Based Approach Of Vaccine Manufacturing Units for 2019 2019-Feb-07 266 KB
9 List of Clinical Trials (rDNA Products) to be inspected in the year 2018 2018-Jan-17 188 KB
10 List of Clinical Trials (Vaccines) to be inspected in the year 2018 2018-Jan-09 244 KB
11 Central Inspection Plan Using Risk Based Approach of Vaccine Manufacturing Units in 2018 2018-Feb-13 278 KB
12 17 list of vaccine manufacturing units inspected 2018-Feb-09 1,353KB
13 Central Inspection Plan using Risk based approach of Vaccine manufacturing units in 2017 2017-Feb-14 129 KB
14 List of Qualified Inspectors for vaccine 2016-Mar-21 407 KB