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Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year 2024 S.no Name of Firm Name of Vaccine Indication Permission No. & Date 1 M/s Zydus Lifesciences Measles, Mumps and It is indicated for prevention of MF/BIO/24/000069, Limited, Plot Survey No. 23, Rubella Vaccine (Live) Measles, Mumps and Rubella virus Date: 25-June-2024 25/P, 37, 40/P, 42 to 47, 49 & I.P. (Freeze Dried) - Multi infections. 50, Sarkhej-Bavla N.H.No. 8A, dose Vial (5.0 ml - 10 Opp. Ramdev Masala, Village – dose). Changodar, Taluka: Sanand, Dist.: Ahmedabad, Gujarat (India) – 382213. 2 M/s Serum Institute of India Covid-19 Vaccine, Vaccine is indicated for active BIO/MA/23/000137, Pvt. Ltd., S. No. 105 110, Adjuvanted 2023-24 immunization to prevent COVID – 19 dated; 06-June-2024 Manjari BK, Tal Haveli, Pune Formula [SARSCoV-2 rS disease (a) in individuals of ≥ 12 to ˂ 412307, Maharashtra (India) Protein (COVID-19) 18 years of age as primary series of Nanoparticle Vaccine, two doses (0.5mL each) 3 weeks Omicron XBB 1.5 variant] apart (b) as single precautionary (COVOVAX) dose in individuals of ≥ 18 years of age, who have received primary series of vaccinations for restricted use in emergency situation. 3 M/s Serum Institute of India Measles and Rubella For active immunization against MF/BIO/24/000055 Pvt. Ltd., 212/2, Off. Soli Vaccine (Live Attenuated) Measles and Rubella in infants, dated 20-May-2024 Poonawalla Road, Hadapsar, (Freeze-Dried), (10 Dose) children, adolescents of age up to 10 Pune, Maharashtra - 411028 (0.5ml/Vial) years. 4 M/s Zydus Lifesciences Measles and Rubella For active immunization in children MF/BIO/24/000052, Limited, Plot , Survey No. 23, Vaccine (Live) I.P. of 9 months of age and older against Date: 16-May-2024 25/P, 37, 40/P, 42 to 47,49 & (Freeze Dried)- Multi Measles and Rubella infections 50, Sarkhej-Bavla N.H. No. 8A, Dose vial (2.5ml - 5 dose). simultaneously Opp. Ramdev Masala, Village – Changodar, Taluka: Sanand, Dist.: Ahmedabad, Gujarat (India) - 382213, Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 5 M/s Serum Institute of India Measles Vaccine, Live For active immunization of all MF/BIO/24/000045 Pvt. Ltd., 212/2, Off. Soli Attenuated (Freeze-Dried) susceptible children against measles dated 25-April-2024 Poonawalla Road, Hadapsar, at 9 months of age. Pune, Maharashtra - 411028 6 M/s Bharat Biotech Cholera Vaccine For active immunization against MF/BIO/24/000043 International Ltd, Genome (Inactivated, Oral), V. Diarrohoeal infection caused by dated 16-April-2024 Valley, Shameerpet, cholerae (O1 El Tor Vibrio cholerae to the children, Hyderabad, India -500078. Hikojima Serotype adolescents and adults aged 1 year recombinant strain) and above with two doses on Day 0 formaldehyde inactivated and Day 14. whole Cell, Phosphate Buffered Saline. 7 M/s Bharat Biotech Rotavirus Vaccine (Live Active Immunization of infants from the MF/BIO/24/000028 International Ltd, Genome Attenuated, Oral) I.P age of 6-8 weeks for prevention of dated 07-March-2024 Valley, Shameerpet, (ROTAVAC 5D)" vaccine gastroenteritis due to rotavirus Hyderabad, India -500078. without antibiotics. infection. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year 2023 S. Name of Firm Name of Vaccine Indication Permission No. & Date No. 1. M/s Cadila Pharmaceuticals Quadrivalent Seasonal For active immunization in adults MF/BIO/23/000003 Limited,1389, Dholka, Influenza Virus-Like and children from 6 months of age dated 18-Jan-2023 Ahmadabad, Gujarat- 382225, Particle (VLP) Vaccine, I.P for the prophylaxis against India. influenza disease caused by influenza virus subtype A and B contained in the vaccine. 2. M/s Gennova Lyophilized mRNA Vaccine The vaccine is indicated as a MF/BIO/23/000055, Biopharmaceuticals Limited for Injection (COVID-19) single booster dose in individuals dated 19-June-2023 [GEMCOVAC®-OM] aged ≥18 years administered at least 4 months after completion of primary vaccination with either COVISHIELD™ or COVAXIN® for restricted use in emergency situation. Additional Indications 1. M/s. Zydus Lifesciences Novel Corona Virus 2019- for administration of heterologous 20-April-2023 Limited, Plot Survey No.23, nCoV Vaccine booster (third) dose of Novel Corona 25/P, 37, 40/P, 42 to 47, (Recombinant) (3 mg, Single Virus 2019- nCoV Vaccine Opposite Ramdev Masala, dose) (Recombinant) (3mg, Single dose) to Sarkhej-Bavla N.H. No. 8A, individuals aged ≥18 years after 6 Changodar, Ahmedabad months of primary vaccination (two (Dist.) India -382 213. doses) of either COVAXIN or COVISHIELD vaccine for restricted use in emergency situation 2. M/s Serum Institute of SARS-CoV-2 rS Protein for administration of heterologous 16-Jan-2023 India Pvt. Ltd., 212/2, Off. (COVID-19) recombinant booster (third) dose to individuals Soli Poonawalla Road, spike protein Nanoparticle aged ≥18 years after 6 months of Hadapsar, Pune, Vaccine primary vaccination (two doses) of Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Maharashtra - 411028 either COVAXIN or COVISHIELD vaccines for restricted use in emergency situation 3. M/s. Zydus Lifesciences Inactivated Influenza Vaccine For active immunization of pediatrics & 24-May-2023 Ltd, Plot Survey No. 23, (Split Virion) IP (Tetravalent) - Children from 6 months to 35 months 25/P, 37, 40/P, 42 To 47 age with two dose schedule 0.5 ml each (BIO/MA/22/000146) Sarkhej-Bavla N.H. No-8A, to 17 years of age as an additional Opposite Ramdev Masala, indication (a dose of 0.5 ml for 3 years to Village Changodar, Tal. 17 years age group and a dose of Sanand Ahmedabad 0.25ml for 6 months to group) for active Gujarat immunization for the prevention of (India) – 382213 disease caused by influenza A subtype viruses and type B viruses Year 2022 S. No. Name of Firm Name of Vaccine Indication Permission No. & Date 1. M/s Bharat Biotech Whole-Virion Inactivated For sale or for distribution in Adult 27-JAN-2022 International Ltd., Coronavirus (SARS- population Genome Valley, CoV-2) vaccine Shameerpet, Hyderabad, India - 500078. 2. M/s Serum Institute of ChAdOx1 nCoV-19 Corona For sale or for distribution in Adult 27-JAN-2022 India Pvt. Ltd., 212/2, Off. Virus Vaccine (Recombinant) population Soli Poonawalla Road, Hadapsar, Pune, Maharashtra - 411028 Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 3. M/s Biological E. Limited, SARS-CoV-2 (Covid-19) For active immunization against MF/BIO/22/000011 18/1 & 3, Azamabad, Vaccine containing Receptor COVID- 19 disease in adults aged Dated 11-FEB-2022 Hyderabad, Telangana - Binding Domain of SARS- 18 years and above when given in 500020. CoV-2 two doses at day 0 & day 28 for restricted use in emergency situation 4. M/s Hetero Biopharma Recombinant adenoviral For the prevention of the COVID-19) MF/BIO/22/000024 Limited, H. No. 8-3-166/1 vector vaccine containing in adults aged over 18 year, when dated 16-MAR-2022 & 2, 105 To 108, 1st particles of serotype 26 administered in single dose of Floor, G Block, East containing the protein S gene (0.5ml) for restricted use in Wing, Challa Estates, of the SARS-CoV- 2 virus emergency situation Erragadda, Hyderabad - 500018 5. M/s Zydus Lifesciences Novel Corona virus-2019- For active immunization to prevent MF/BIO/22/000034 Limited., Plot Survey No. nCoV Vaccine (Recombinant) COVID-19 caused by SARS- CoV- 2 Dated 25-Apr-2022 23, 25/P, 37, in individuals 12 years of age and 40/P, 42 to 47, Opp. older when given in two separate Ramdev Masala, Sarkhej- doses of 3mg (0.3ml) each to be Bavla, N.H. No. 8A, given at an interval of 28 days each Village- Changodar, (day 0, day 28). Taluka - Sanand, Dist. Ahmedabad - 382213, 6. M/s Panacea Biotec Ltd., Adsorbed Diphtheria, For active immunization for MF/BIO/22/000043 Ambala-Chandigarh Tetanus, Pertussis, prevention against Diphtheria, dated: 20-May-2022 Highway, Post office Poliomyelitis (Inactivated) Tetanus, Pertussis (Whooping Lalru, District Sahibzada and Haemophilus Cough), infections caused by Ajit Singh Nagar Punjab- influenzae Type b Haemophilus influenzae Type b & 140 501, India Conjugate Vaccine I.P. Poliomyelitis. Posology: One paediatric dose is of 0.5 ml to be administered Intramuscularly with an interval of Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines four weeks between doses, starting at 6 weeks of age (6, 10 and 14 weeks of birth) 7. M/s Human Biologicals Measles and Rubella Vaccine For active immunization in children MF/BIO/22/000058 Institute (A division of (Live) I.P. of 9 months of age and older dated 27-JUNE-2022. Indian Immunologicals against Measles and Rubella. (0.5 Limited), Rakshapuram ml single dose). Gachibowli Post Rangareddi Hyderabad (India) - 500032 8. M/s Gennova Lyophilized mRNA Vaccine For active immunization against MF/BIO/22/000064 Biopharmaceuticals for Injection (COVID-19) COVID- 19 disease in adults aged dated 28-JUN-2022 Limited [HGCO- 19] 18 years and above when given in two doses at day 0 & day 28. 9. M/s Seasons Biologicals Tetanus Vaccine (Absorbed) For active immunization against MF/BIO/22/000068 dated Private Limited, I.P tetanus infection when 04-JULY-2022 administered as single dose of 0.5 ml in the age group of 10 to 45 years. 10. M/s Serum Institute of Quadrivalent Human For active immunization in the MF/BIO/22/000072 Dated India Pvt., Ltd., 212/2, Papilloma Virus (Serotypes age group of 9-14 years (male 12-JULY-2022 Off. Soli Poonawalla 6,11, 16 & 18) Vaccine and female), two- doses schedule Road, Hadapsar Pune (Recombinant) (qHPV) (0 and 6 months) and for age (India) – 411028 group of 15-26 years (male and female), three-dose schedule (0, 2 and 6 months) for prevention of the disease caused by Human Papilloma Virus types 6, 11, 16 and 18. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 11. M/s Human Biologicals Diphtheria & Tetanus For active immunization against MF/BIO/22/000078 Institute (A division of vaccine for Adults & Diphtheria and Tetanus in dated 25-Aug-2022 Indian Immunologicals Adolescents I.P. Adolescents (10 years to below Limited), Rakshapuram 18 years) & Adults (age 18 years Gachibowli Post to 60 years). Rangareddi Hyderabad (India) - 500032 12. M/s Bharat Biotech ChAd36-SARS-CoV-S For active immunization against MF/BIO/22/000083 International Ltd., COVID-19 (Chimpanzee COVID- 19 in the age group of 18 dated 05-Sep-2022 Genome Valley Adenovirus Vectored) years and above when given in Shamirpet, Hyderabad, recombinant COVID- 19 two doses [0.5ml each Telangana, India – 500 Vaccine (Nasal) administered intranasally as 4 078 drops (0.25 mL) in each nostril] at day 0 & day 28 interval. 13. M/s Serum Institute of Diphtheria, Tetanus, For active immunization of infants, at MF/BIO/22/000086 Dated India Pvt., Ltd., 212/2, Pertussis (Whole Cell), or above the age of 6 weeks against 14-SEPT-2022 Off. Soli Poonawalla Hepatitis-B (rDNA), Diphtheria, Tetanus, Pertussis, Road, Hadapsar Pune Poliomyelitis Hepatitis B, Poliomyelitis and invasive (India) – 411028 (Inactivated) and disease caused by Haemophilus Haemophilus influenzae influenzae type b for 3 dose regimen type b Conjugate Vaccine (6, 10 & 14 weeks) for primary (Adsorbed) I.P. vaccination and Booster dose at the age of 12-24 months. 14. M/s Serum Institute of Diphtheria, Tetanus and For active booster immunization MF/BIO/22/000088 India Pvt., Ltd., 212/2, Pertussis (Acellular, against Tetanus, Diphtheria, and dated 21-SEP-2022 Off. Soli Poonawalla component) Vaccine Pertussis in individuals aged 4 years Road, Hadapsar Pune [adsorbed, reduced to 65 years. (India) – 411028 antigen(s) content] Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 15 M/s Serum Institute of [Meningococcal For active immunization of individuals MF/BIO/22/000089 Dated India Pvt Ltd, 212/2, Off. (A,C,Y,W,X) Polysaccharide aged 18-85 years against invasive 26-SEPT-2022 Soli Poonawalla Road, Conjugate Vaccine (Freeze- meningococcal disease caused by Hadapsar Dried)] Neisseria Meningitidis serogroups A, Pune (India) – 411028 C, Y,W, and X. 16. M/s Human Biologicals Inactivated Hepatitis A For prevention of Hepatitis A infection MF/BIO/22/000095 Institute (A division of Vaccine, IP (Adsorbed) IP for 0.5mL dose of children (above 1 Dated: 17-OCT-2022 Indian Immunologicals years) & adolescents and 1 mL in Limited) Rakshapuram, adults (aged 10 years to 49 years). Gachibowli Hyderabad, Telangana-500032 17. M/s Biological E. Limited, Pneumococcal For active Immunization against MF/BIO/22/000112 Plot No. 1, Phase II, Polysaccharide Conjugate invasive disease caused by Dated: 10-DEC-2022 Biotech Park, Kolthur Vaccine (Adsorbed) I.P. (14 Streptococcus Pneumonia serotype Village, Shameerpet, Valent) 1,3,4,5,6B,7F,9V,14 Medchal-Malkajgiri 18C,19A,19F,22F,23F and 33F in District, Telangana INDIA infants from 6 weeks of age group for 500078. 3 dose schedule (6,10 & 14 weeks). Approval of New indications of Approved Vaccines S. Name of Firm Name of Vaccine Indication Date of approval No. 1. M/s Biological E. Limited, Covid-19 vaccine containing For Covid-19 vaccine containing 21-FEB-2022 Plot No. 1, Phase II, Receptor Binding Domain of Receptor Binding Domain of SARS- Biotech Park, Kolthur SARS-CoV-2 (RBD antigen of CoV-2 (RBD antigen of SARS CoV- Village, Shameerpet, SARS CoV-2 (Covid-19) 2 (Covid-19) for use in age group of Medchal-Malkajgiri District, ≥12 to <18 years with the dose Telangana INDIA 500078. schedule of 0 & 28 days for restricted use in emergency situation. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 2. M/s Serum Institute of India SARS-CoV-2 rS Protein For SARS-CoV-2 rS Protein (COVID- 09-MAR-2022 Pvt. Ltd. 212/2, Off Soli (COVID- 19) recombinant 19) recombinant spike protein Poonawalla Road, spike protein Nanoparticle Nanoparticle Vaccine for use in age Hadapsar, Pune, Vaccine group of ≥12 to <18 years with the Maharashtra (India)- dose schedule of 0 & 21 days for 411028. restricted use in emergency situation. 3. M/s Bharat Biotech Whole Virion inactivated Whole Virion inactivated corona virus 25-APR-2022 International Ltd., corona virus vaccine vaccine for use in age group of >6 to Genome Valley, <12 years with the dose schedule of 0 Shameerpet, Hyderabad, & 28 days for restricted use in India -500 078. emergency situation. 4. M/s Biological E. Limited, Covid-19 vaccine for Covid-19 vaccine containing 25-APR-2022 Plot No. 1, Phase II, containing Receptor Receptor Binding Domain of SARS- Biotech Park, Kolthur Binding Domain of SARS- CoV-2 (RBD antigen of SARS CoV-2 Village, Shameerpet, CoV-2 (RBD antigen of (Covid-19) for use in age group of ≥5 Medchal-Malkajgiri District, SARS CoV-2 (Covid-19) to <12 years with the dose schedule Telangana INDIA 500078. of 0 & 28 days for restricted use in emergency situation. 5. M/s Biological E. Limited, SARS-CoV-2 (RBD For administration as heterologous 03-JUNE-2022 Plot No. 1, Phase II, antigen of SARS CoV-2 booster (third) dose to individuals Biotech Park, Kolthur (Covid-19) aged Village, Shameerpet, ≥18years to 80 years after 6 months Medchal-Malkajgiri District, of administration of primary Telangana INDIA 500078. vaccination (two doses) of COVAXIN or COVISHIELD vaccine for restricted use in emergency situation. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 6. M/s Serum Institute of India SARS-CoV-2 rS Protein SARS-CoV-2 rS Protein 28-JUNE-2022 Pvt. Ltd., 212/2, Off Soli (COVID- 19) recombinant (COVID-19) recombinant spike Poonawalla Road, spike protein Nanoparticle protein Nanoparticle Vaccine for use Hadapsar, Pune, Vaccine in the age group of ≥7 to Maharashtra (India)- <12 years for restricted use in 411028 emergency situation. 7. M/s Zydus Lifesciences Typhoid Vi Conjugate For active immunization against 08-SEPT-2022 Limited, Plot Survey No. 23, Vaccine I.P. Salmonella typhi infection in 6 months 25/P, 37, 40/P, 42 to 47, to 65 years age group. Opp. Ramdev Masala, Sarkhej- Bavla, N.H. No. 8A, Village - Changodar, Taluk- Sanand, Dist. Ahmedabad - 382 213 8. M/s Serum Institute of India Pneumococcal For additional indication to permission 01-NOV-2022 Pvt. Ltd., 212/2, Off Soli Polysaccharide Conjugate no. MF/BI0/20/000059 dated 14-Jul- BIO/MA/22/000063 Poonawalla Road, Vaccine (Adsorbed) (I0- 2020 as to be administered as 2+1 Hadapsar, Pune, Valent) schedule (6 weeks, 14 weeks & 9 Maharashtra (India)- months of age) 411028 9 M/s Bharat Biotech ChAd36-SARS-CoV-S For new (additional) indication to 25-NOV-2022 International Ltd., Genome (Chimpanzee Adenovirus permission no. MF/BIO/22/000083 Valley Shamirpet, vectored) recombinant dated 06.09.2022 administer booster BIO/MA/22/000095 Hyderabad, Telangana, India COVID-19 vaccine dose (third dose) after 6 months to – 500 078 individuals of age >18 years who have already administered primary (two doses) of COVAXIN or COVISHIELD vaccines. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year: 2021 S. Name of Firm Name of Vaccine Indication Permission No. & No. Date 1. M/s Serum Institute of ChAdOx1 nCoV-19 Corona For Restricted use in emergency MF/BIO/21/000001 India Pvt. Ltd. 212/2, Off. Virus Vaccine situation: For active immunization dated 03-Jan-2021 Soli Poonawalla Road, (Recombinant) of individuals of ≥18 years old for Hadapsar Pune, the prevention of corona virus Maharashtra, India. disease (COVID-19) when administered in two doses schedule. The second dose should be administered between 4 to 6 weeks after the first dose. However, there is data available for administration of the second dose up to 12 weeks after the first dose from the overseas studies. 2. M/s Bharat Biotech Whole Virion Inactivated For Restricted use in emergency MF/BIO/21/000002 International Limited, Sy. Corona Virus Vaccine, situation in clinical trial mode: dated 03-Jan-2021 No. 230, 231 & 235, [BBV152] For active immunization against Genome Valley, Corona Virus Disease (COVID-19) Shameerpet Mandal, for age ≥18 years when Medchal-Malkajgiri administered in two doses interval District,Telangana- of day 0 & day 28. 500078, India. 3. M/s Serum Institute of Diphtheria, Tetanus and For the primary immunization of MF/BIO/21/000003 India Pvt. Ltd. 212/2, Off. Pertussis Vaccine infants, at or above the age of 6 dated 04-JAN-2021 Soli Poonawalla Road, (Adsorbed) I.P. weeks, and of children through six Hadapsar Pune, years of age against diphtheria, Maharashtra, India. tetanus and whooping cough. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 4. M/s Serum Institute of ChAdOx1 nCoV-19 Corona For Restricted use in emergency MF/BIO/21/000019 India Pvt., Ltd., S.No. Virus Vaccine situation: For active immunization Dated 11-Feb-2021 105-110, Manjari, (Recombinant) of individuals of ≥18 years old for Budruk, Pune, the prevention of corona virus Maharashtra 412307, disease (COVID-19) when India. administered in two doses schedule. The second dose should be administered between 4 to 6 weeks after the first dose. However, there is data available for administration of the second dose up to 12 weeks after the first dose from the overseas studies. 5. M/s Biological E. Limited, Inactivated Hepatitis A For active immunization against MF/BIO/21/000033 Plot No. 1, Phase II, Vaccine (Adsorbed), IP Hepatitis A virus (HAV) in 1 to 15 dated 13-Apr-2021 Biotech Park, Kolthur years of age group Village, Shameerpet Mandal, Medchal- Malkajgiri District, Telangana -500078 6. M/s Serum Institute of BCG for immunotherapy For treatment of flat Urothelial cell 21 June 2021 India Pvt. Ltd., 212/2, Off. I.P. carcinoma in situ of urinary bladder BIO/MA/21/000044 Soli Poonawalla Road, and as adjunctive therapy following Hadapsar Pune (India) – transurethral resection of primary or 411 028. relapsing superficial non-invasive papillary tumors that are limited to the bladder mucosa (stage Ta or T1). Intravesical BCG Immunotherapy has been shown to reduce tumor recurrence and prevent progression Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 7. M/s Ra (biologicals) Gam-COVID-Vac For Restricted use in MF/BIO/21/000057 Panacea Biotec Ltd., A- combined vector emergency situation: For the Dated 02-Jul-2021 27, B-1 Extension Mohan vaccine (Component I & prevention of the novel Coronavirus Cooperative Industrial Component II) Sputnik V infection (COVID-19) in Estate, Mathura Road vaccine adults aged over 18, when given in New Delhi – 110044, two separate doses three weeks India. apart. Day 0: Component I (0.5 ml) & Day 21: Component II (0.5ml) 8. M/s Zydus Lifesciences Diphtheria and Tetanus For active immunization of children MF/BIO/21/000059 Limited, Zydus Corporate Vaccine (Adsorbed) for 10 years of age or older, adolescents dated 15-Jul-2021 Park Scheme No. 63, Adults and Adolescents I.P. and adults, against tetanus and Survey No. 536, Near diphtheria. Nirma University, Vaishnov Devi Circle Khoraj (Gandhinagar) S. G. Highway, Ahmedabad – 382481, Gujarat 9. M/s Bharat Biotech Whole Virion For Restricted use in emergency MF/BIO/21/000069 International Limited at Inactivated Corona situation: For active immunization dated 09-Aug-2021 M/s Chiron Behring Virus Vaccine, [BBV152] against Corona Virus Disease Vaccines Private Limited, (COVID-19) for age ≥18 years when Plot No. 3502, G.I.D.C., administered in two doses interval of Estate P. B No. 136, day 0 & day 28. Dist. Bharuch, Ankleshwar, Gujarat (India)-393 002. 10. M/s. Biological E. Limited, COVID-19 vaccine For active immunisation to prevent MF/BIO/21/000080 SEZ- Unit Sy.No:549, (Ad26.COV2- S COVID-19 caused by SARS-CoV-2 Dated 18-Aug-2021 550, 552 to 556, Kolthur [recombinant]) (Janssen in individuals 18 years of age and Village, Shameerpet, Vaccine) older when given in single dose (0.5 Medchal- Malkajgiri mL). District, Telangana, India Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines –500 078. 11. M/s Zydus Lifesciences Novel Corona virus-2019- For Restricted use in MF/BIO/21/000081 Limited, Plot Survey No. nCoV Vaccine emergency situation: For active Dated 20-Aug-2021 23, 25/P, 37, 40/P, 42 to (Recombinant) immunization to prevent COVID-19 47,Opp. Ramdev Masala, caused by SARS-CoV-2 Sarkhej- Bavla, N.H. No. in individuals 12 years of age 8A, Village - Changodar, and older when given in three Taluka – Sanand Dist. separate doses of 2mg (0.2ml) Ahmedabad - 382 213 each to be given at an interval of 28 days each (day 0, day 28 and day 56). 12. M/s Bharat Biotech Typhoid Vi conjugate For active immunization against 23-Aug-2021 International Ltd., vaccine IP [Typhoid Salmonella Typhi infection in ≥6 (Additional Genome Valley, (Vi Capsular months to ≤65 year age group indication) Shameerpet, Hyderabad, Polysaccharide) – India -500078. Tetanus Toxoid conjugate vaccine] 13. M/s Bharat Biotech Diphtheria, Tetanus, For the primary immunization of MF/BIO/21/000107 International Ltd., Pertussis (Whole Cell) and infants aged 6 weeks and above as dated 20-SEP-2021 Genome Valley, Haemophilus influenzae three dose schedule at 6, 10 & 14 Shameerpet, Hyderabad, Type b Conjugate weeks against disease like India -500078. Vaccine (Adsorbed) IP. diphtheria, tetanus and whooping cough and those caused by Heamophilus Influenzae Type b. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 14. M/s Diphtheria and Tetanus For active immunization as booster MF/BIO/21/000112 CENTRALRESEARCH Vaccine (Adsorbed) for dose at the age of 10 years and 16 dated 08-Oct-2021 INSTITUTE KASAULI Adults and Adolescents years against tetanus and DIST- SOLAN KASAULI I.P. diphtheria India Pincode : 173204 15. M/s. Hetero Gam-COVID-Vac For the prevention of the MF/BIO/21/000110 Biopharma combined novel Dated 05-Oct-2021 Limited H.No. 8-3-166/1 & vector vaccine Coronavirus infection 2, 105 To 108, 1st Floor, (Component I & (COVID-19) in adults aged over 18, G Block, East Wing, Component II)Sputnik V when given in two separate doses Challa Estates, vaccine three weeks apart. Day 0: Erragadda, Hyderabad Component I (0.5 ml) & Day 21: India Pincode : 500018 Component II (0.5ml) 16. M/s Human Biologicals Tetanus Vaccine For active immunization at more than MF/BIO/21/000117 Institute (A division of (Adsorbed) I.P. equals to 6 weeks against dated 09-NOV-2021 Indian Immunologicals Tetanus. Also For Prevention of Limited), Rakshapuram tetanus in all age groups following Gachibowli Post injury or animal bite and to persons Rangareddi Hyderabad who are at increased risk of (India) attaining injuries through their - 500032 occupation or recreational activities. 17. M/s Serum Institute of BCG for immunotherapy For treatment of flat Urothelial cell MF/BIO/21/000128 India Pvt., Ltd., S. No. I.P., 40 mg/ml carcinoma in situ of urinary bladder dated 16.12.2021 105-110, and as adjunctive therapy following Manjari, Budruk, Pune, transurethral resection of primary or Maharashtra 412307 relapsing superficial non-invasive papillary tumors that are limited to the bladder mucosa (stage Ta or T1). Intravesical BCG Immunotherapy has been shown to reduce tumor recurrence and prevent progression. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 18. M/s Bharat Biotech Whole Virion inactivated Additional indication of whole virion 24.12.2021 International Ltd., Genome corona virus vaccine inactivated corona virus vaccine for Valley, Shameerpet, use in age group of >12 to 18 years Hyderabad, India -500 with the dose schedule of 0 and 078. 28 days for restricted use in emergency situation. 19. M/s Serum Institute of SARS-CoV-2 rS Protein For active immunization to prevent MF/BIO/21/000138 India Pvt.Ltd. S.No. (COVID- 19) recombinant COVID-19 caused by SARS CoV-2 Dated 28-Dec-2021 105-110, Manjari BK, Tal spike protein Nanoparticle in individuals 18 years of age and –Haveli, Pune- 412307, Vaccine older when administered in two Maharashtra (India) dose schedule of day 0 & day 21. 20. M/s Serum Institute of SARS-CoV-2 rS Protein For active immunization to prevent India Pvt. Ltd. 212/2, Off (COVID- 19) recombinant COVID-19 caused by MF/BIO/21/000137 Soli Poonawalla Road, spike protein Nanoparticle SARS CoV-2 in individuals 18 Dated 28-Dec-2021 Hadapsar, Pune, Vaccine years of age and older when Maharashtra (India)- administered in two dose schedule 411028 of day 0 & day 21. 21. M/s Biological E. SARS-CoV-2 (Covid-19) For active immunization against MF/BIO/21/000136 Limited Plot No. 1, Phase Vaccine containing COVID-19 disease in D a ted 28-Dec-2021 II, Biotech Park, Kolthur Receptor Binding Domain of adults aged 18 years and Village, Shameerpet, SARS-CoV-2 above when given in two doses at Medchal- Malkajgiri day 0 & day 28. District, Telangana INDIA 500078 22. M/s Serum Institute of Influenza Vaccine (Human, For active Immunization against MF/BIO/21/000139 India Pvt. Ltd. 212/2, Off Live Attenuated) I.P., influenza disease caused by two Dated 30-Dec-2021 Soli Poonawalla Road, Quadrivalent influenza A subtype viruses and Hadapsar, Pune, two influenza Type B viruses in the Maharashtra (India)- age group of 2 years and above. 411028 Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year 2020 S. Name of Firm Name of Vaccine Indication Permission No. & No. Date 1 M/s Biological E. Limited, Typhoid Vi Conjugate For active immunization against MF/BIO/20/000001 Plot No. 1, Phase II, Vaccine, IP infection caused by Salmonella dated 28.01.2020 Biotech Park, Kolthur typhi in infants, children, Village, Shameerpet adolescents and adults aged ≥ 6 Mandal, Medchal- months to ≤ 45 years. Malkajgiri District,Telangana- 500078,India 2 M/s Serum Institute of Bacillus Calmette-Guerin For prevention of tuberculosis. MF/BIO/20/000037 India Pvt., Ltd., S. No. Vaccine I.P. (Freeze-Dried) (Dose of 0.05 ml for children under Dated 29.04.2020 105-110, one month of age and 0.1 ml for Manjari, Budruk, Pune, children over one month of age and Maharashtra 412307,India adults) 3 M/s. Cadila Recombinant Rabies G Active immunization against rabies MF/BIO/20/000040 Pharmaceuticals Limited Protein Vaccine for Post-exposure treatment (after dated 08.05.2020 1389-Trasad Road Dholka exposure) in 18 to 65 years of age: Ahmedabad - 382225 Treatment after contact with Gujarat (India) animals which are rabid or suspected to be rabid, or after contact with an inoculated rabies carcass Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 4 M/s Zydus Lifesciences Hepatitis B Vaccine (r- For active immunization against MF/BIO/20/000052 Limited, plot survey no. DNA) I.P. Hepatitis B vaccine infection in dated 09.06.2020 23, 25/P, 37, 40/P, 42 To adults up to 50 years of age. 47 Sarkhej-Bavla N.H. No-8A, Opposite Ramdev Masala, Village Changodar, Tal. Sanand, Ahmedabad-382213, Gujarat,India 5 M/s Zydus Lifesciences Diphtheria, Tetanus, For active immunization of infants, MF/BIO/20/000053 Limited, plot survey no. Pertussis (Whole Cell), at or above the age of 6 weeks dated 19.06. 2020 23, 25/P, 37, 40/P, 42 To Hepatitis B (r- DNA) and against Diphtheria, Tetanus, 47 Sarkhej-Bavla N.H. Haemophilus Influenzae Whooping cough, Hepatitis B and No-8A, Opposite Ramdev Type b Conjugate Haemophilus influenza type b Masala, Village Vaccine (Adsorbed) I.P. infections for 3 dose regimen. Changodar, Tal. Sanand, Ahmedabad-382213, Gujarat, India 6 M/s Serum Institute of Pneumococcal For active immunization against MF/BIO/20/000059 India Pvt. Ltd. 212/2, Off. Polysaccharide Conjugate invasive disease & pneumonia dated 14.07.2020 Soli Poonawalla Road, Vaccine (Adsorbed) I.P. caused by Streptococcus Hadapsar Pune, (10- Valent) pneumonia serotypes 1,5, 9V, 14, Maharashtra, India. 19A, 19F, 23F, 7F, 6A & 6B in infants from 6 weeks of age group for 3 dose regimen (dosing schedule : 6, 10 & 14 weeks) Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year 2019 S. Name of Firm Name of Vaccine Indication Permission No. & No. Date 1 M/s Venky Parenterals, Tetanus Vaccine For active immunization against all MF/BIO/19/000001 Unit of Sriguru Capital (Adsorbed), I.P. childrens from age of 6 weeks dated 28-Jan-2019 Services Limited onwards and those who are exposed Advipolam Yanam to occupational /risks such as road Puducherry (India) - workers, Athletes, agricultural 533464 workers, industrial workers, defense personnel,homeguards and police personnel. 2 M/s Serum Institute of Poliomyelitis Vaccine For active immunization of infants MF/BIO/19/000002 India Pvt., Ltd., 212/2, Off. (Inactivated) I.P. (as young as 6 weeks of age), dated 31-Jan-2019 Soli Poonawalla Road, (Manufactured using children and adults for the prevention Hadapsar, Pune Poliomyelitis bulks imported of poliomyelitis caused by poliovirus Maharashtra (India)- from M/s Bilthoven Types 1, 2, and 3. 411028 Biologicals B.V. (BBIO), The Netherlands) 3 M/s Bio Vaccines (India) Tetanus Vaccine (Adsorbed) For active immunization against MF/BIO/19/000015 Private Limited 46-A, I. P. tetanus between 10 to 60 years age dated 18.03.2019 Sector A Sanwer Road, group. Industrial Area, Madhya Pradesh 452015 4 M/s Serum Institute of Rotavirus Vaccine(Live For active immunization of healthy MF/BIO/19/000031 India Pvt., Ltd., 212/2, Off. Attenuated, Oral) IP (Liquid) infants from the age of 6 weeks for dated 10.06.2019 Soli Poonawalla Road, the prevention of gastroenteritis due Hadapsar, Pune to rotavirus infection when Maharashtra (India)- administered as a 3-dose series. The 411028 three dose regimen should be Completed by one year of age. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 5 M/s BCG Vaccine Bacillus Calmette-Guerin For immunization of infants from MF/BIO/19/000036 Laboratory, 110, 33 Feet vaccine (Freeze Dried) IP birth untill age of 1 year against dated 26-Jul-2019 Wide Road, Mount Road, childhood tuberculosis. Guindy, Chennai Guindy, Tamil Nadu (India) – 600 032 6 M/s Cadila Mycobacterium w (Heat Indicated as an adjuvant in sepsis MF/BIO/19/000057 Pharmaceuticals Limited, Killed) (due to gram negative infections) dated 28.11.2019 1389-Trasad Road, treatment when given as 0.1ml for Dholka (India) – 387 81, three consecutive days in age group India of 18 to 65 years. Year 2018 S. Name of Firm Name of Vaccine Indication Permission No. & No. Date 1 M/s Bharat Biotech Rotavirus Vaccine (Live Active immunization of infants from the MF/BIO/18/000022, International Limited, Attenuated, Oral) I.P. age of 6-8 weeks for preventions of dated: 31.08.2018 Genome [ROTVAC 5D] gastroenteritis due to rotavirus Valley,Shameerpet, infection. Hyderabad-500078, A.P., India Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 2 M/s. Zydus Lifesciences Measles and Rubella Vaccine For active immunization in children of 9 MF/BIO/18/000036 Limited, Plot Survey No. (Live), I.P. (Freeze Dried) months of age and older against dated: 26.12.2018 23, 25/P, 37, 40/P, 42 To Measles and Rubella infections 47 Sarkhej-Bavla N.H. No- simultaneously 8A, Opposite Ramdev Masala, Village Changodar, . Tal. Sanand Ahmedabad Gujarat (India) – 382213 Approval of New indications of Approved Vaccines S. Name of Firm Name of Vaccine Indication Date of approval No. 1 M/s. Zydus Lifesciences Inactivated Influenza Vaccine For active immunization of pediatrics & 10.12.2018 Limited, Plot Survey No. (Split Virion) IP (Tetravalent) - Children from 6 months to 17 years of 23, 25/P, 37, 40/P, 42 To age as an additional indication (a dose (BIO/MA/18/000030) 47 Sarkhej-Bavla N.H. No- of 0.5 ml for 3 years to 17 years age 8A, Opposite Ramdev group and a dose of 0.25ml for 6 Masala, Village Changodar, months to 35 months age group) for Tal. Sanand Ahmedabad active immunization for the prevention Gujarat of disease caused by influenza A (India) – 382213 subtype viruses and type B viruses Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year 2017 S. Name of Firm Name of Vaccine Indication Permission No. & No. Date 1 M/s Human Biologicals Diphtheria, Tetanus, Diphtheria, Tetanus, Pertussis MF-131/2017, Institute (A division of Pertussis (Whole Cell), (Whole Cell), Hepatitis B (rDNA) and dated: 09.06.2017 Indian Immunologicals Hepatitis B (rDNA) and Haemophilus influenzae Type b Limited), Rakshapuram Haemophilus Conjugate Vaccine (Adsorbed) is Gachibowli Post influenzae Type b indicated for the active immunization Rangareddi Hyderabad Conjugate Vaccine of infants, at or above the age of 6 (India) (Adsorbed) weeks against Diphtheria, Tetanus, - 500032 whooping cough, Hepatitis-B and Haemophilus influenza type b infections 2 M/s Bio-Med Ghaziabad Varicella Vaccine Freeze Varicella Vaccine, Live, I.P. is MF-183/2017, (P) Ltd., dried indicated for active immunization dated: 31.07.2017 (Live) I.P. against Varicella virus (Chicken Pox) for use in children of 1 to 12 years of age. 3 M/s Biological Telangana Measles and Rubella For active immunization against MF- 190/2017, E. Limited, Vaccine (Live), I.P. Measles and Rubella in 9 to 12 dated: 16.08.2017 (Attenuated, Freeze Dried) months healthy infants at risk. 4 M/s. Zydus Lifesciences Typhoid Vi Conjugate For active immunization against MF- 274/2017, Limited, Ahmedabad Vaccine I.P. Salmonella typhi infection in adults, Dated:15.12.2017 Gujarat children and infants. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year-2016 S. No. Name of Firm Name of Vaccine Indication Permission Date No. & 1 M/s Serum Institute of Rabies Vaccine Human I.P. (Freeze Rabies Vaccine Human MF- 77/2016, dated: India Pvt. Ltd., Pune Dried) I.P. is indicated for the 20.05.2016 prevention of rabies in children and adults. It can be used before and after exposure, as a primary immunization or as a booster dose. 2 M/s Panacea Biotec Easy Four-TT (DTwP-Hib) For active immunization MF- 99/2016, dated: Ltd., New Delhi Vaccine against Diphtheria, 13.06.2016 Tetanus, Pertussis (Whooping cough) and infection caused by Haemophilus Type-b. 3 M/s. Zydus Lifesciences Measles, Rubella Mumps Vaccine For prevention of MF-104/2016, Limited, Ahmedabad, (Live) I.P.(Freeze Dried Measles , Rubella & Dated 30.06.2016 Gujarat Mumps Virus Infection 4 M/s. Zydus Lifesciences Tetanus Vaccine (Adsorbed) I.P. For prevention of MF-117/2016, Limited, Ahmedabad, Clostridium Tetani. Dated:13.07.2016 Gujarat 5 M/s. Zydus Lifesciences Measles Vaccine (Live) I.P.(Freeze Measles vaccines (Live) MF- 123/2016, Dated Limited, Ahmedabad, Dried) I.P. (Freeze Dried) is :14.07.2016 Gujarat immunization of all susceptible children against measles. It is recommended to be given to children at 9 months of age or, as Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines soon as thereafter, to protect against measles in early life. 6 M/s Bharat Biotech Inactivated JE vaccine For active immunization MF-149/2016, dated: International Ltd., of disease caused by 29.08.2016 Hyderabad Japanese Encephalitis Virus (JEV) 7 M/s. Zydus Lifesciences Inactivated Influenza Vaccine (Split The vaccine indicated MF-176/2016, Ltd., Ahmedabad, Virion) I. P. (Tetravalent) in adults (≥18 years of dated: 01.11.2016 Gujarat age) for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year-2016 S. No. Name of Firm Name of Vaccine Indication Permission No.& Date 8 M/s Panacea Biotec Ltd., DTwP-HepB-Hib-IPV For active immunization for prevention MF- 186/2016, New Delhi Vaccine against Diphtheria, Tetanus, Pertussis dated:16.11.2016 (Whooping Cough), Hepatitis B infection, Infections caused by Haemophilus influenzae type b and poliomyelitis 9 M/s. Zydus Lifesciences LimitedD, i phtheria, Tetanus, For prevention of Clostridium tetani and MF-192/2016, Ahmedabad Gujarat Pertussis (whole cell) Corynebacterium diphtheriae and dated Vaccine Bordetella Pertussis : 28.11.2016 (Adsorbed) I.P. 10 M/s. Zydus Lifesciences LimitedIn, a ctivated Influenza The vaccine indicated in adults (≥18 MF- 204/2016,dated: Ahmedabad Gujarat Vaccine (Split Virion) I. P. years of age) for active immunization 07.12.2016 (Trivalent) for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. 11 M/s Serum Institute of India Rotavirus Vaccine It is indicated for active immunization of MF- 222/2016,dated: Pvt. Ltd., Pune (Attenuated, Oral) I.P. healthy infants from the age of 6 weeks 23.12.2016 (Freeze Dried) for the prevention of gastroenteritis due to rotavirus infection when administered as a 3 dose series. 12 M/s. Zydus Lifesciences LimitedV, a ricella Vaccine (Live) I.P. For active immunization for the MF-18/2017, dated: Ahmedabad Gujarat (Freeze Dried) prevention of varicella in age group 18.01.2017 between 1-12 years Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year-2015 S. Name of Firm Name of Vaccine Indication Permission No. & Date No. M/s Cadila Monovalent H1N1- VLP 09 For active immunization for the MF- 70/2015, 1 Pharmaceuticals, Survey Vaccine prevention of disease caused by H1N1 dated: 12.03.2015 No. 1389, Trasad Road, 2009 influenza virus in the age group Dholka, Ahmedabad- of 18 years and above. 387810 2 M/s Sanofi Healthcare Inactivated Polio vaccine For active immunization against MF-147/2015, India Pvt Ltd Hyderabad Poliomyelitis caused by Poliovirus dated:19.06.2015 types 1, 2 and 3 in infants, children and adults both for primary immunization and for boosters. 3 M/s Bharat Rabies Vaccine, Thiomersal Active Immunizing Agent against MF-.200/2015, Biotech Limited., Free Rabies caused by Rabies Virus dated:11.09.2015 Hyderabad Infection 4 M/s Human Rabies Vaccine, Human I.P. Pre-exposure & Post-exposure MF- 244/2015, Biologicals Institute (A (1ml) prophylaxis against Rabies Infection. dated: 08.12.2015 division of Indian Immunologicals Limited), Rakshapuram Gachibowli Post Rangareddi Hyderabad (India) - 500032 5 M/s Human Rabies Vaccine, Human I.P. Pre-exposure & Post-exposure MF-245/2015, Biologicals Institute (A (0.5ml) prophylaxis against Rabies Infection. dated:08.12.2015 division of Indian Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Immunologicals Limited), Rakshapuram Gachibowli Post Rangareddi Hyderabad (India) - 500032 6 M/s Cadila Trivalent Influenza Vaccine Active immunization of adults, 18 MF-252/2015, Pharmaceuticals Ltd. years of age and above against dated:16.12.2015 disease caused by Influenza virus subtypes A& Types B contained in the vaccine. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year-2014 S. Name of Firm Name of Vaccine Indication Permission No. & Date No. 1 M/s HLL Biotech Hepatitis B vaccine (r-DNA) Indicated for the prevention of MF-243/2014, Limited, Plot No. 1, S. Hepatitis B infection dated:14.11.2014 P. Biotech Park, Phase-II, Kolthur Village, Shameerpet Mandal, R. R. District, Andhra Pradesh- 500078. 2 M/s HLL Biotech DTP- Hib –Hep Active immunization against MF-245/2014, Limited, Plot No. 1, S. Diphtheria, Tetanus, Pertussis, dated:17.11.2014 P. Biotech Park, Hepatitis –B and Haemophilus Phase-II, Kolthur Type b infection Village, Shameerpet Mandal, R. R. District, Andhra Pradesh- 500078. 3 M/s Biomed Pvt Rabies vaccine human Pre exposure immunization- The MF253/2014 Limited, C-96, Site – (cell culture IP ) vaccine is recommended for the ,dated:20.11.2014 1, Bulandshahr Road prevention of Rabies in subjects Industrial Area, at a continuous risk of exposure. Ghaziabad – 201 009 (U.P.) INDIA 4 M/s Biomed Pvt Oral Poliomyelitis vaccine, For active Immunization against MF-269/2014, Limited, C-96, Site–1, Live IP. Poliomyelitis virus. dated:10.12.2014 Bulandshahr Road Industrial Area, Ghaziabad – 201 009 (U.P.) INDIA Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year-2014 S. Name of Firm Name of Vaccine Indication Permission No. & Date No. M/s Biomed Pvt Typhoid Polysaccharide For prevention of Typhoid fever MF- 123/2014, Limited, C-96, Site – vaccine (IP) dated:02.06.2014 5 1, Bulandshahr Road Industrial Area, Ghaziabad – 201 009 (U.P.) INDIA Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year-2013 S. Name of Firm Name of Vaccine Indication Permission No. & Date No. 1 M/s Bharat Bivalent Oral Polio For the immunization of against MF-78/2013, Immunologicals & Vaccine- Sabin strain (Type Polio virus type I and type III. dated: 23.04.2013 Biologicals I and Type III) (Bulk source Corporation Limited, from M/s P.T. Bio Farma, Village Chola, Indonesia) Bulandshahr-203203 (U.P.) 2 M/s Bharat Trivalent Oral Polio For the immunization of against MF-79/2013, Immunologicals & Vaccine- Sabin (Type 1, Polio virus type I, type II and type dated: 22.05.2013. Biologicals Type 2 and Type 3) (Bulk III. Corporation Limited, source from M/s Village Chola, P.T. Bio Farma, Indonesia) Bulandshahr-203203 (U.P.) 3 M/s Bharat Biotech Poliomyelitis Vaccine, Live Active immunization against MF-154/2013, Internal limited, (Oral), I.P., Trivalent-Sabin Poliomyelitis caused by type 1, dated:24.07.2013. Genome Valley, (Type1, Type 2 and Type type 2 and type 3 infection. Shameerpet Mandal, 3) Hyderabad, Andhra Pradesh India- 500078 Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 4 M/s Bio-Med (P) Ltd., Poliomyelitis Vaccine, Live Poliomyelitis vaccine, Live (Oral) MF- 188/2013, C- 96, B.S. Road, (Oral), I.P., Trivalent I.P. (trivalent) is indicated for dated: 16.08. 2013. Indl. Area, active immunization of Ghaziabad-201009, Poliomyelitis virus. Infants U.P., India. should receive at least three doses of OPV at minimum interval of 4 weeks. WHO recommends the following schedule in endemic countries at birth, 6, 10, 14 weeks. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year-2013 S. Name of Firm Name of Vaccine Indication Permission No. & Date No. 5 M/s Serum Institute of Influenza Vaccine, Live For active Immunization against MF 193/2013, India Ltd., 212/2, attenuated (Human) influenza disease caused by date: 03.09.2013 Hadapsar, Pune-411- Seasonal Trivalent freeze influenza subtype A and type B 028 dried 2013 Southern viruses in the age group of 2 Hemisphere influenza years and above season 6 M/s Bharat Biotech Oral Rotavirus Vaccine Active Immunization of infants MF- 192/2013, dated Internal limited, (ORV) 116E from the age of 6 weeks for the 03.09.2013 Genome Valley, prevention of gastroenteritis due Shameerpet Mandal, to rotavirus infection. Hyderabad, Andhra Pradesh India- 500078 7 M/s Biological E Ltd, Hepatitis B vaccine (rDNA) Indicated for the prevention of MF- 197/2013 dated Plot No. 1, SP Biotech I.P. Hepatitis B infections 05.09. 2013 Park, Phase II, Kolthur(V), Shameerpet (M), Ranga reddy (Dist.) Andhra Pradesh 8 M/s GlaxoSmithKline Hepatitis B vaccine Active immunization against MF-70/2013 dated: Asia Pvt Ltd., A-10/1, (rDNA) IP (Engerix B) HBV infection caused by all 09.09.2013 M.I.D.C. Ambad- known subtypes in subjects of Pathardi Phara, all ages considered at risk of Ambad, Nashik- exposure to HBV 422010 Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year-2013 S. Name of Firm Name of Vaccine Indication Permission No. & Date No. 9 M/s Dano Vaccines & Tetanus Toxoid (Adsorbed) I.P For active immunization MF-146/2013, Biologicals Private Ltd. against Tetanus. dated:08.07.2013 575, Sivareddyguda, Ghatkesar, R.R. Distt., Andhra Pradesh, 501301. 10 M/s Biologicals E. Diphtheria and Tetanus Indication for prevention of Disease MF- 142/2013, Ltd.,18/1 & 3, Vaccine (Adsorbed) IP caused by Diphtheria and Tetanus dated: 12.07.2013 Azamabad, Hyderabad- in Adults and adolescents. 500 020 A. P. India. 11 M/s Biologicals E. Ltd., Tetanus Vaccine (Adsorbed) IP Indicated for prevention of Tetanus MF- 196/2013, 18/1 & 3, Azamabad, Infections. dated: 04.09.2013 Hyderabad-500 020 A. P. India. 12 M/s Biologicals E. Diphtheria, Tetanus and whole Indicated as Prophylaxis for MF-201/2013, Ltd.,18/1 & 3, cell Pertussis Vaccine Diphtheria, Tetanus and Pertussis dated:13.09.2013 Azamabad, Hyderabad- (Adsorbed) IP 500 020 A. P. India. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year-2012 S. Name of Firm Name of Vaccine Indication Permission No. & Date No. 1 M/s Bharat Biotech Inactivated Japanese For the Immunization of disease MF- 181/2012, Internal limited, Encephalitis Vaccine caused by Japanese Encephalitis dated; 07.06.2012 Genome Valley, virus (JEV). Dosage schedule Shameerpet Mandal, Adult/Children (1 to 50 years)-Two Hyderabad, Andhra doses of 0.5ml on day 0 and day Pradesh India- 500078 28±2. 2 M/s Bharat Biotech Typhoid (Vi Capsular For active immunization against MF- 244/2012 International Ltd., Polysaccharide) - Tetanus Salmonella Typhi infection in ≥6 Dated: 20.12.2012 Genome Valley, Toxoid Conjugate vaccine months to 45 year age group. Shameerpet, Hyderabad-500078 Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year-2011 S. Name of Firm Name of Vaccine Indication Permission No. & Date No. 1 M/s Panacea Biotec Bivalent Oral Poliomyelitis For Prophylactic for prevention MF-195/11, Ltd., B-1 Extn. /A- Vaccine Type 1 and Type caused by Type 1 and Type 3 strains dated: 29.04. 2011 27, McIE, 3, Live (Oral) (bOPV) [ Bulk of poliovirus Mathura Road, New Source: Sanofi Pasteur, Delhi- 110 044, India. France] 2 M/s Serum Institute of Influenza Vaccine (Whole Inactivated H1N1 split virion vaccine MF- 242/2011, dated: India Ltd., 212/2, Virion, Inactivated) is an inactivated influenza virus 02.06.2011 Hadapsar, Pune-411 (Pandemic H1N1 Vaccine), vaccine indicated for active 028, India. (Embryonated hen eggs immuniztion of children above 3 derived and inactivated years of age and adults against by influenza disease caused by betapropiolactone Pandemic (H1N1) 2009 virus. 3 M/s. Zydus Lifesciences Rabies Vaccine, Human IP For active Immunization against MF- 320/2011, Limited, (Purified Chick embryo cell rabies;- For Intramuscular dated: 16.08.2011 Sarkhej-Bavla, N.H. 8A, culture rabies vaccine) administration, use 1 full dose(1ml) Moraiya, Tal. Sanand, PCECVPM for pre & Post exposure prophylaxis Ahmedabad-380 015. For Intradermal administration, use 0.1 ml per ID site for Post exposure prophylaxis 4 M/s Biological E Ltd, Plot Japanese Encephalitis For the immunization of disease MF- 456/2011, No. 1, SP Biotech Park, Inactivated Vaccine caused by Japanese Encephalitis dated: 29.09.2011 Phase II, Kolthur(V), virus (JEV) for adult (18-49 years) Shameerpet(M), Ranga and Children (1-3 years) Dosage Reddy (Dist.) Andhra Schedule: Adult-Single dose of 0.5 Pradesh ml and Children –Two dose of 0.25 ml at 4 week apart. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 5 M/s Serum Institute of Meningococcal A For active immunization against MF 458/2011, India Ltd., Conjugate vaccine, invasive meningococcal disease dated:18.10.2011 212/2, Hadapsar, Lyophilized (Clear glass vial caused by Meningococcus group A Pune-411 -028 with white Aluminium flip-off only, in the children of age 2 years, seals) adolescent and adults up to 29 years of age. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year-2010 S. Name of Firm Name of Vaccine Indication Permission No. & Date No. 1 M/s. Bharat Biotech Bivalent Polio Type 1 & For active Immunization against Type MF-224/10, dated: International Ltd., Type 3 vaccine , Live Oral 1 & Type 3 Poliomyelitis infection in 12.03.2010 Genome Valley, Children from 0 to 5 years of age. Shameerpet (Mandal), Reddy (Dist), Hyderabad-500078 (AP) 2 M/s. Zydus Inactivated Influenza For active immunization against MF-466/10, Lifesciences Limited., vaccine (Whole virion) IP influenza disease caused by dated:11.05.2010 Sarkhej-Bavla, N.H. Pandemic Influenza (H1N1) pandemic (H1N1) 2009 virus in the No. 8A, Moraiya, Tal, 2009, Monovalent vaccine). age group of 18 years and above. Sanand, Dist. Ahmedabad– 382 210 3 M/s Serum Institute of Influenza Vaccine (Live For active immunization against MF-558/10, dated: India Ltd.,212/2, Attenuated freeze dried) for influenza disease caused by 18.06.2010 Hadapsar,Pune-411 Intranasal. pandemic (H1N1) 2009 virus in the 028, age group of 03 years and above. 4 M/s Panacea Biotec DTwP-vaccine (adsorbed) For the primary immunization of MF 822/10, dated: Ltd., B-1 Ext/A-27, infants at or above the age of 6 21.09.2010 Mohan Co-op Indl. weeks & of children through 6 years Estate , Mathura of age against Diphtheria, Tetanus & Road, New-Delhi- 110 Whooping cough 044 5 M/s Biological E. Ltd., Liquid pentavalent vaccine Active immunization of Against MF 843/10, dated: 18/1 and 3, Diphtheria, pertussis, tetanus, 29.09.2010 Azamabad, Hepatitis b, Hib type b infection Hyderabad- Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines 500 020 6 M/s Bharat Pandemic Influenza For active immunization of persons MF-847/10, dated: Biotech International Vaccine A( H1N1) o f age 18 years to 65 years against 30.09.2010 Ltd., Genome Valley, Virus vaccine (Inactivated) influenza disease caused by Shameerpet, pandemic influenza A (H1N1) 2009 Hyderabad- 500 078 virus (A.P.) 7 M/s Panacea Biotec Inactivated H1N1 split For active immunization of children MF-898/10, ltd., B-1 Extn. A-27, virion Influenza vaccine above 3 years of age and adults dated:08.11.2010 Mohan Co- op. indl. (adjuvanted) against disease caused by Estate, Mathura Pandemic (H1N1) Road, new Delhi- 110 2009 virus. 044. Format No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Manufacturing Permissions of Human Vaccines Year-2009 S. Name of Firm Name of Vaccine Indication Permission No. & Date No. 1 M/s Biomed (P) Ltd., Meningococcal For active immunization against MF-7/09, C-96, Site No1, polysaccharide vaccine Neisseria meningitidis Group A &C dated:12.01. Bulandsahar (Group A &C) 2009 Road, Industrial Area, Ghaziabad ,U.P. 2 M/s Serum Institute of Diphtheria, Tetanus, For active immunization against MF-167/09, India Ltd., Pertussis, Hepatitis-B and Diphtheria, Tetanus, Pertussis, dated: 12.02.2009 212/2, Haemophilus Hepatitis- B and Haemophilus Hadapsar, Pune-411 Influenzae Type b Influenzae Type b in infants. 028, India. Conjugate Vaccine Adsorbed, liquid. 3 M/s Panacea Biotec Oral Poliomyletis Vaccine Active Immunization against MF-175/09, Ltd., B-1 Extn.A/27., (Type 1, 2, &3) infection caused by type 1, 2 & 3 dated: 24.02.2009 MCIE, Polioviruses. Mathura Road, New Delhi 4 M/s Panacea Biotec Diphtheria ,Tetanus and For the primary immunization of MF-282/09, Ltd., ,B-1 Extn.A- whole cell pertussis (DTwP) Infants ,at or above the age of 6 dated: 19.03.2009 27,MCIE,Mathura vaccine weeks ,and of children through six Road, New-Delhi -110 years of age against Diphtheria 044 ,Tetanus and whooping cough 5 M/s Human Biologicals Rabies Vaccine (Vero Cell For active immunization against MF-295/09, Ltd., (A Division of cultured , Freeze Dried) Rabies, both as prophylaxis and post dated: 23.03.2009 Indian Immunological bite cases. ltd.), Rakhshapuram, Gachibowli, Hyderabad (AP) Format No. QMS-GNL-019/F01(b)-00Details of Human Vaccines approved by CDSCO (for manufacture) (Year 1998 to 2008) S. Name of Firm Name of Vaccine Indication Permission No No. & Date 1998 1 M/s Bharat Biotech International Hepatitis B Vaccine (recombinant DNA) For active immunization against infection 12-30/86-DC, 726, Road-3, Banjara Hills, caused by Hepatitis-B Viruses. Date:-14-10- Hyderabad-500034 1998 2003 1 M/s Aventis Pasteur India Pvt. Ltd. Inactivated adsorbed Hepatitis A Vaccine 80 For prevention of Infection caused of Hep. MF-675/2003, Chaitanya 1, Chaman Farm Village, antigen unit A virus in children in the age group of 12 Dated: 07-06- Bundh Road, Chattarpur, New months – 15 years. 2003 Delhi-30 2 M/s Cadila Healthcare Ltd. , Zydus Purified Vi-Capsular Polysaccharide typhoid For active immunization against typhoid MF-821/2003, Towers, Satellite cross Roads, vaccine fever in adults and children over 2 years of Date: 09-09-2003 Ahemadabad-15 age. 3 M/s Bharat Biotech International Vi capsular Polysaccharide Typhoid Vaccine For immunization against typhoid fever. 12-3/2002-DC, Ltd., Genome Valley Turkapally, Date: 23-01-2003 Shameerpet (Mandal), Hyderabad – 500078 2004 1 M/s Bio-Med Pvt. Ltd., Bulandsahar Haemophillus Influenza type-b conjugated For prevention of invasive disease caused MF-1350/2004, Road Indi. Area, Ghaziabad-201001 Vaccine. by Haemophillus Influenza type-b in Date: 14-06-2004 children. 2 M/s Bio-Med Pvt. Ltd., KB-27, Meningococcal Polysaccharide Vaccine (Group For prevention of cerebrospinal meningitis MF-1752/2004, Kavi Nagar, Ghaziabad-201002 A, C, W135 & Y) caused by Neisseria meningitides group A, Date: 23-09-2004 (UP) India C, Y, W135 & Y. Vaccination is recommended for travelers moving in the endemic regions. 2005 1 M/s Serum Institute of India Ltd., Combined DP (Whole Cell) T + r-Hepatitis B For active immunization against Diphtheria, MF-2090/2005, 212/2, Hadapsar, Pune-411028 Vaccine. Tetanus, Pertussis and Hepatitis B in infants Date: 28-02-2005 and children. 2006S. Name of Firm Name of Vaccine Indication Permission No No. & Date 1 M/s. Biological E. Ltd., 1811 & 3 , Combined DTPw (whole cell) + r-Hepatitis-B For active immunisation against Diphtheria, MF-6567/06, Azamabad, Hyde r a b ad-500 020, Vaccine. Tetanus, Pertussis & Hep.-B in children. Date – 24-04- A.P 2006 2 M/s Bharat Biotech International Anti-Rabies Vaccine (Verocell) For active immunization against Rabies MF-7076/2006, Ltd., Genome Valley Turkapally, Date: 14-12-2006 Shameerpet (Mandal), Hyderabad – 500078 3 M/s Bharat Biotech International Diphtheria, Tetanus & Pertussis Vaccine For the active immunization against MF-6857/2006, Ltd., Genome Valley Turkapally, (adsorbed) Diphtheria, Tetanus & Pertussis Date: 28-08-2006 Shameerpet (Mandal), Hyderabad – 500078 2007 1 M/s Panacea Biotech Ltd., B-1 Diphtheria+Pertussis+Tetanus Vaccine with For active immunization against Diphtheria, MF-7912/2007, Extn. / A-27 Mohan Co-operative Hepatitis B and Haemophillus influenza type B Pertussis, Tetanus, Heapatitis B and Date: 12-09-2007 Industrial Estate, Mathura Road Vaccine. Haemophillus influenza type B infection. New Delhi-110044 2 M/s Panacea Biotech Ltd., B-1 Haemophillus type b (Hib) conjugate vaccine. For active immunization against MF-7517/2007, Extn. / A-27 Mohan Co-operative Haemophillus influenza type b infection in Date: 06-06-2007 Industrial Estate, Mathura Road children of the age group of 6 weeks to 5 New Delhi-110044 years. 3 M/s Bharat Biotech International Haemophillus Influenza type b (Hib) conjugate For active immunization against MF-7581/2007, Ltd., Genome Valley Turkapally, vaccine Haemophillus influenza type b infection in Date; 03-07-2007 Shameerpet (Mandal), Hyderabad – children of the age group of 6 weeks to 5 500078 years. 4 M/s Serum Institute of India Ltd., Diphtheria, Tetanus, Pertussis (Whole Cell) + For the active immunization of infants, at or MF-7929/2007, 212/2, Hadapsar, Pune-411028 Haemophillus Influenza-b vaccine. above the age of 6 weeks against Date: 04-10-2007 Diphtheria, Tetanus, Whooping cough and Haemophillus influenza type-b infections. 5 M/s Serum Institute of India Ltd., DTPw Hepatitis B + Hib Vaccine For active immunization against Diphtheria, MF-7390/2007, 212/2, Hadapsar, Pune-411028 Tetanus, Pertussis, Hepatitis B and Date: 03-05-2007 Haemophillus influenza type b 6 M/s Serum Institute of India Ltd., Haemophillus Influenza type b (Hib) conjugate For active immunization against MF-7100/2007, 212/2, Hadapsar, Pune-411028 vaccine Haemophillus influenza type b infection in Date: 12-01-2007 children of the age group of 6 weeks to 5S. Name of Firm Name of Vaccine Indication Permission No No. & Date years. 7 M/s Biological E Ltd., 18/1 & 3, Haemophillus Influenza type b (Hib) conjugate For active immunization against MF-7496/2007, Azamabad, Hyderabad-500020 vaccine (Lyophilised) Haemophillus influenza type b infection in Date: 08-06-2007 children of the age group of 6 weeks to 5 years. 8 M/s Bharat Biotech International Monovalent Poliomyelitis Vaccine Type 1 Live For active immunization against Polio in MF-7633/2007, Ltd., Genome Valley Turkapally, (Oral). children. Date: 20-07-2007 Shameerpet (Mandal), Hyderabad – 500078 2008 1 M/s Bharat Biotech International Diphtheria, Tetanus, Pertussis (W), r-Hepatitis B For active immunization against Diphtheria, MF-227/2008, Ltd., Genome Valley Turkapally, & Haemophillus Influenza Type-B Vaccine Tetanus, Pertussis (W), r-Hepatitis B & Date: 31-01-2008 Shameerpet (Mandal), Hyderabad – Haemophillus Influenza Type-B infection 500078 2 M/s Aventis Pasteur India Pvt. Ltd. Diphtheria, Tetanus, Acellular Pertussis and For the immunization of Diphtheria, MF-370/2008, Chaitanya 1, Chaman Farm Village, Inactivated Poliomyelelitis (DtacP-IPV) Tetanus, Pertussis and poliomyelitis in Date: 31-03-2008 Bundh Road, Chattarpur, New combined vaccine. (From M/s sanofi infants from 2 months of age. Delhi-30 Pasteur,France) 3 M/s Green Signal Bio Pharma Pvt. BCG Vaccine (Live, Freeze Dried, attenuated) For active immunization against MF-1395/ 2008, Ltd., Old No. 86, New No. 114, Dr. tuberculosis Date: 22-12-2008 Radhakrishna Salai, Mylapore, Chennai, Tamilnadu- 600004, India 4 M/s Bio-Med Pvt. Ltd., C-96 Site 1, Typhoid Vaccine (Vi Polysaccharide Conjugate) For active immunization against Typhoid MF-528/2008, B.S.Road, Industrial, Area, Date: 09-05-2008 Ghaziabad-201009 (U.P) 5 M/s Bharat Biotech International Monovalent Oral Poliomyelitis Type-3 vaccine For the active immunization against MF-262/2008, Ltd., Genome Valley Turkapally, Poliomyelitis. Date: 29-02-2008 Shameerpet (Mandal), Hyderabad – 500078 6 M/s Bharat Biotech International Diphtheria+ Tetanus +Pertussis + Hepatitis B + For active immunizations against diphtheria, MF-515/2008, Ltd., Genome Valley Turkapally, Haemophilus influenza Type B-Vaccine Tetanus, Pertussis, Hepatitis B & Date: 12-05-2008 Shameerpet (Mandal), Hyderabad – Haemophilus influenza Type B 500078