Central Drugs Standard Control Organization

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

Vaccines

S.no1 Title Release Date Download Pdf Pdf Size
1 NSQ of Typhoid Polysaccharide Vaccine (TYPBAR) manufactured by M/s Bharat Biotech International Limited 2023-Jun-06 180 KB
2 COVID-19 vaccines approved for Manufacture for Sale or for Distribution in the country as on 26.07.2023 2023-Jul-26 657 KB
3 NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd 2018-Mar-14 905KB
4 Samples declared NSQ 2017 2017-Dec-26 80 KB
5 Samples declared NSQ 2013-2016 2016-Dec-28 31 KB
6 Product Recalls 2014-Dec-18 50 KB
S.no vACCINE 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 SmPC of MenFive vaccine of of Ms Serum Institute India Pvt Ltd 2022-Oct-26 337 KB
2 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 of Quadrivalent HPV vaccine of M/s Serum Inst. of India Pvt., Ltd., Pune 2023-Feb-16 296 KB
2 SmPC of the Polysaccharide Polysaccharide Conjugate Vaccine (Adsorbed) I.P. (14 Valent) of M/s Biological E Ltd 2023-Aug-30 524 KB
3 Factsheet of the ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) of M/s Serum Institute of India 2023-Apr-24 1813 KB
4 SmPC of the ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) of M/s Serum Institute of India 2023-Apr-24 12655 KB
5 SmPC, factsheet & PI of Incovacc (Nasal) vaccine of Ms Bharat Biotech for age 18 years and above 2022-Sep-09 1014 KB
6 SmPC of MenFive vaccine of of Ms Serum Institute India Pvt Ltd 2022-Oct-11 337 KB
7 SmPC of Shan5 with inhouse HBsAg by Ms Sanofi Healthcare India Pvt Ltd 2022-Nov-15 501 KB
8 SmPC of Inactivated Influenza Vaccine (Surface Antigen) I.P Quadrivalnet of Ms Abbott India 2022-Nov-08 3788 KB
9 SmPC of Shan6 Mono-dose of by Ms Sanofi Healthcare India Pvt Ltd 2022-May-25 147 KB
10 SmPC & factsheet of COVOVAX of M/s Serum for age 7 years and above 2022-Jul-25 609 KB
11 SmPC & factsheet of CORBEVAX of M/s Biological E for age 5 years and above 2022-Jul-22 1003 KB
12 SmPC & factsheet of COVAXIN vaccine of M/s Bharat Biotech for age 6 years and above 2022-Jul-22 8276 KB
13 SmPC & factsheet of COVOVAX of M/s Serum for age 12 years and above 2022-Jul-22 2909 KB
14 SmPC & factsheet of Gemcovac vaccine of M/s Gennova for age 18 years and above 2022-Jul-22 339 KB
15 SmPC & factsheet of Sputnik Light vaccine of M/s Dr. Reddy's Lab. for age 18 years and above 2022-Jul-22 649 KB
16 SmPC & factsheet of ZyCoV-D (3 mg) vaccine of M/s Cadila for age 12 years and above 2022-Jul-22 887 KB
17 SmPC of QUADRIVALENT INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) I.P of Ms Sanofi Healthcare . 2022-Jul-13 184 KB
18 Factsheet of Corbevax vaccine manufactured by M/s Biological E 2022-Jan-19 265 KB
19 SmPC of Corbevax vaccine manufactured by M/s Biological E 2022-Jan-18 636 KB
20 SmPC of Shan5 with imported HBsAg by Ms Sanofi Healthcare India Pvt Ltd 2022-Feb-25 249 KB
21 SmPC of Shan6 Multi-dose of by Ms Sanofi Healthcare India Pvt Ltd 2022-Feb-22 138 KB
22 ZyCoV-D vaccine of M/s Cadila 2022-Feb-03 311 KB
23 SmPC & factsheet of COVOVAX of M/s Serum 2022-Feb-02 498 kb
24 SmPC & factsheet of CORBEVAX of M/s Biological E 2022-Feb-02 3605 KB
25 SmPC & factsheet of Janssen vaccine of M/s Johnson & Johnson 2022-Feb-02 329 KB
26 COVAXIN (Adults & adolescents) of M/s Bharat Biotechv 2022-Feb-02 11612 KB
27 SmPC of BCG vaccine by Ms Serum Institute, Hadapsar ,Pune 2022-Dec-31 368 KB
28 SmPC of BCG for Immunotherapy-40 mg by Ms Serum Institute India Pvt Ltd 2022-Dec-31 501 KB
29 SmPC of DTP Vaccine of Ms Serum Institute India Pvt Ltd 2022-Dec-31 69 KB
30 SmPC of Hexavalent Vaccine of Ms Serum Institute India Pvt Ltd 2022-Dec-31 268 KB
31 SmPC of NASOVAC-S4 (22-23-NH) - SmPC of Ms Serum Institute India Pvt Ltd 2022-Dec-31 90 KB
32 SmPC of Pneumosil vaccine by Ms Serum Institute 2022-Dec-31 417 KB
33 SmPC of Poliomyelitis Vaccine (Inactivated) I.P., POLIOVAC of Ms Serum Institute India 2022-Dec-31 337 KB
34 SmPC of Rotavirus vaccine (Liquid) by Ms Serum Institute 2022-Dec-31 358 KB
35 SmPC & PI of Measles and Rubella Vaccine Live I.P. of M/s Serum 2022-Dec-06 249 KB
36 SmPC of Gam-COVID-Vac Combined vector vaccine (Component I & II) SPUTNIK V of Dr. Reddy's Laboratories Ltd 2021-May-23 292 KB
37 Factsheet of Gam-COVID-Vac Combined vector vaccine (Component I & II) SPUTNIK V of Dr. Reddy's Laboratories Ltd 2021-May-23 616 KB
38 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
39 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
40 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
41 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
42 SmPC of Typbar-TCV of Ms Bharat Biotech 2021-Jun-29 524 KB
43 SmPC of ChAdOx1 nCoV- 19 CORONA VIRUS VACCINE (RECOMBINANT) of M/s Serum Institute of India 2021-Jan-15 2781 KB
44 SmPC of Whole Virion Inactivated Corona Virus Vaccine of Ms Bharat Biotech 2021-Jan-15 202 KB
45 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
46 SmPC of Inactivated Hepatitis A Vaccine of Ms Biological E Pvt Ltd 2021-Apr-13 510 KB
47 SmPC of ROTAVAC 5D by Ms Bharat Biotech 2021-Apr-12 437 KB
48 SmPC of Comvac 4 of Ms Bharat Biotech 2020-Sep-30 215 KB
49 SmPC of Meningococcal Group A, C, W135 and Y Conjugate Vaccine of Ms GSK 2020-Sep-25 483 KB
50 SmPC of Typhoid Conjugate Vaccine (Bio E. Ltd) 2020-Jan-28 170 KB
51 SmPC of Diphtheria, tetanus, pertussis (acellular component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed) of Ms GSK 2019-Sep-24 321 KB
52 Biomed - Rabies vaccine 2019-Mar-12 117 KB
53 MSD-Varicella Vaccine Variped 2017-Feb-17 246 KB
54 MSD_Zoster vaccine India PI 1 2017-Feb-17 241 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 Bharat Biotech -Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b 2017-Feb-17 65 KB
71 Serum - Influenzae Vaccine 2017-Feb-17 2092 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
97 Cadila Healthcare Tetanus Vaccine 2017-Feb-17 94 KB
98 Cadila Healthcare Varicella Vaccine 2017-Feb-17 75 KB
99 Cadila Healthcare- VaxiRab N (PCECV) 2017-Feb-17 1400 KB
100 Cadila-Monovalent H1N1-09 VLP Vaccine 2017-Feb-17 1734 KB
101 Cadila- Trivalent Influenzae Vaccine 2017-Feb-17 988 KB
102 Dano-Tetanus Toxoid 2017-Feb-17 2516 KB
103 GSK-Boostrix 2017-Feb-17 117 KB
104 GSK-Cervarix 2017-Feb-17 159 KB
105 GSK-EngerixB Ped & Adult 2017-Feb-17 134 KB
106 GSK-FLuarix 2017-Feb-17 140 KB
107 GSK-Havrix 1440 & 720 2017-Feb-17 96 KB
108 GSK-Poliorix 2017-Feb-17 50 KB
109 GSKPriorix 2017-Feb-17 121 KB
110 GSK-Priorix Tetra 2017-Feb-17 155 KB
111 GSK-Rotarix Lyo 2017-Feb-17 353 KB
112 GSK-Synflorix 2017-Feb-17 244 KB
113 GSK-Twinrix Adult 2017-Feb-17 82 KB
114 GSK-Varilrix 2017-Feb-17 103 KB
115 HLL-DTP-Hib-Hep 2017-Feb-17 3307 KB
116 Hll-Hepatitis B Vaccine 2017-Feb-17 2053 KB
117 Human Biologicals- Rabies vaccine Human I_P 2017-Feb-17 3663 KB
118 JE Biological E Ltd JE SPC 2017-Feb-17 113 KB
119 Man Mill Inactivated Influenza Vaccine 2017-Feb-17 167 KB
120 MSD- Pneumococcal Vaccine Pneumovax 2017-Feb-17 216 KB
121 MSD- qHPV Vaccine Gardasil 2017-Feb-17 339 KB
122 MSD - Rotavirus Vaccine Rotateq 2017-Feb-17 357 KB
123 SmPC of TCV Vaccine by Ms Cadila Healthcare 2017-Dec-15 179 KB
124 SmPC for TCV Vaccine of Ms Cadila Healthcare 2017-Dec-15 176 KB
125 SmPC of MR Vaccine (Bio E. Ltd) 2017-Aug-16 272 KB
S.no Title Release Date Download Pdf Pdf Size
1 Details of manufacturing permissions of Human Vaccines approved by CDSCO 2009 to 2023 till date 2023-Sep-08 905 KB
2 Details of manufacturing permissions of Human Vaccines approved by CDSCO 2009 - 29 Aug 2023 2023-Aug-29 923 KB
S.no Title Release Date Download Pdf Pdf Size
1 Details of Import Permissions of Human Vaccines approved by CDSCO 2009 - 29 Aug 2023 2023-Aug-29 514 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