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Annexure-I(b) Details of Import Permissions of Human Vaccines Year-2024 S. No Name of Firm Name of Formulation Indication(s) Permission No. & Date 1 M/s G.C. Chemie Pharmie Pneumococcal For active immunization against disease caused IMP/BIO/24/000013 Ltd. 5C Laxmi Industrial Polysaccharide by Streptococcus pneumonia serotypes dated 31.01.2024 Estate New Link Road Conjugate Vaccine I.P. 1,3,4,5,6A,6B,7F,9V,14,18C,19A,19F,23F in Andheri, Mumbai, India (PCV13-TT) (Adsorbed) infants from 6 weeks of age group for 3 dose regimen (dosing schedule 6, 10 and 14 weeks). Year-2023 S. No Name of Firm Name of Formulation Indication(s) Permission No. & Date 1 M/s TechInvention Choler Vaccine For Prevention of Cholera in individuals from IMP/BIO/23/000044 Lifecare Pvt. Ltd, (Inactivated, Oral), I.P age 1 years and above caused by Vibrio dated 17-Apr-2023 Mumbai, India. cholerae. 2 M/s Prosper Channel Life Hepatitis A vaccine for active immunization against Hepatitis A virus IMP-30/2023, Science India Pvt., Ltd, New (Human in 18-40 years of age group”. dated 21-April- Delhi, India. Diploid Cell) Inactivated .2023 3. M/s Prosper Channel Life Hepatitis A vaccine for active immunization against Hepatitis A virus Additional Indication Science India Pvt., Ltd, New (Human in 1-15 years 27-July-.2023 Delhi, India. Diploid Cell) Inactivated Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines Year 2022 S. No Name of Firm Name of Formulation Indication(s) Permission No. & Date 1. M/s Dr Reddy’s Recombinant adenoviral For the prevention of the Novel Coronavirus IMP/BIO/20/000067 Laboratories Limited, vector vaccine containing infection (COVID-19) in adults aged over 18 dated 04-Feb-2022 Hyderabad, India particles of serotype 26 year, when administered in single dose of containing the protein S (0.5ml) for restricted use in emergency gene of the SARS-CoV- situation. 2virus 2. M/s GlaxoSmithKline Herpes Zoster Vaccine For prevention of Herpes Zoster (HZ) and IMP/BIO/22/000014 Pharmaceuticals Limited, (Recombinant, Post-Herpetic Neuralgia (PHN), in adults 50 dated 21-Feb-2022 252, Dr. Annie Besant Adjuvanted) years of age or older when administered in Road Worli Mumbai, two doses of 0.5 ml each two months apart Maharashtra 3. M/s Sanofi Healthcare Inactivated Quadrivalent Inactivated Quadrivalent Influenza Vaccine 22.04.2022 India Private Limited, Influenza Vaccine (Split (Split Virion) I.P. for 0.5ml dose in the age Mumbai, India Virion) I.P. for 0.5ml dose group of 6 to 35months. 4. M/s GlaxoSmithKline Inactivated For active immunization of adults and Dated 06.05.2022 Pharmaceuticals Limited Quadrivalent children from 6 months of age for the Dr. Annie Besant Road, Influenza Vaccine prevention of influenza disease caused by BIO/IMP/21/000021 Worli, Mumbai 400030, (Split Virion) I.P., the two influenza A virus subtypes and the India. 0.5ml, single dose, two influenza B virus types contained in the prefilled syringe (PFS). vaccine 5. M/s G. C. Chemie Pharmie Pneumococcal For active immunization for the prevention of IMP/BIO/22/000065 Ltd., 5/C, Polysaccharide pneumococcal disease caused by the 23 dated 03.10.2022 Shree Laxmi Industrial Vaccine I.P.(23 valent ) serotype contained in the vaccine (1, 2, 3, 4, Estate, New Link Road, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, Andheri (West), Mumbai, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and India 33F) for use in adults aged 18 to 65 years when administered in single dose of 0.5 ml Year-2021 Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines S. No Name of Firm Name of Formulation Indication(s) Permission No. & Date M/s Dr Reddy’s Laboratories Gam-COVID -Vac For Restricted use in emergency situation: IMP/BIO/21/000011 1 Limited, 8-2-337, Road No. 3 combined vector For the prevention of the novel Coronavirus dated 12-Apr-2021 Banjara Hills Hyderabad (India) vaccine (Component infection (COVID-19) in adults aged over 18, – 500034. I & Component II) when given in two separate doses three weeks apart. Day 0: Component I (0.5 ml) & Day 21: Component II (0.5ml) 2 M/s Pfizer Ltd., Pneumococcal For active immunization for the prevention of Additional indication The Capital 1802/1901 Plot No. Polysaccharide Pneumonia and invasive disease caused by dated 17-May-2021 C-70, G Block Bandra-Kurla Conjugate Vaccine Streptococcus pneumoniae serotypes 1, 3, 4, 5, Complex, Bandra (E) Mumbai (Adsorbed) I.P., 13 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in City (India) – 400051 valent adults of 18 years to 49 years of age 3 M/s Cipla Limited, Cipla House, mRNA-1273 COVID- For Restricted use in emergency situation: IMP/BIO/21/000035 Peninsula Business Park 19 vaccine (Moderna) For active immunization to prevent COVID-19 dated 29-Jun-2021 Ganpatrao Kadam Marg, caused by Severe Acute Respiratory Syndrome Lower Parel, Mumbai Lower Coronavirus 2 (SARS-CoV-2) in individuals 18 Parel (India) – 400013 years of age and older when given in two doses. (0.5 mL each) 28 days apart. 4 M/s. Johnson & Johnson Pvt. COVID-19 vaccine For Restricted use in emergency situation: IMP/BIO/21/000048 Ltd., L.B.S. Marg, Mulund (Ad26.COV2-S For active immunisation to prevent COVID-19 dated 06-Aug-2021 (West) Mumbai, Maharashtra caused by SARS-CoV-2 in individuals 18 years [recombinant]) India Pincode : 400080 of age and older when given in single dose (0.5 mL). 5. M/s Dr. Reddy’s Laboratories Live Attenuated Active immunization against Hepatitis A in IMP/BIO/21/000090 Limited,8-2-337, Road No. 3, Hepatitis A Vaccine adultsand children Above one year age. dated 25-OCT- Banjara Hills, Hyderabad, 500 (Freeze-dried) 2021 034, Telangana, India. Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines 6. M/s. Glaxosmithkline Rotavirus Vaccine For active immunization of infants from the age IMP/BIO/21/000099 Pharmaceuticals Limited, 252, (Live Attenuated, Oral) of 6 weeks for prevention of gastro-enteritis due dated 08-Dec-2021 Dr. Annie Besant Road, Worli, I.P. to rotavirus infection (Dose schedule 0,1 month) Mumbai, Maharashtra – 400030, India Year-2020 S. No Name of Firm Name of Formulation Indication(s) Permission No. & Date M/s Sinopharm India Private Hepatitis A (Live) For immunization against Hepatitis A IMP/BIO/20/000067 dated 1 Limited, Unit 403-404, 4th floor vaccine, Freeze virus to prevent Hepatitis A in age 03.09.2020 Southern Park, Saket District dried group of 1 to 12 years. Centre, Tal Greater Kailash(50) Delhi-110017,India. Rabies Vaccine, For Pre-exposure prophylaxis and M/s Zuventus HealthcareLtd., IMP/BIO/20/000002 dated 2 Human, IP (Vero post exposure Office No. 5119, 5th Floor, “D” 14.02.2020 Cell), (Freeze Dried) prophylaxis of Rabies. Wing, Oberoi Garden states, As per following Chandivali, Andheri (E), schedule Pre-exposure prophylaxis Mumbai-400072, India. : Day0, Day7 & Day28 Post exposure prophylaxis : Day 0, Day 3, Day 7, Day 14 & Day 28 Year-2019 S. No Name of Firm Name of Formulation Indication(s) Permission No. & Date M/s GlaxoSmithKline Inactivated Influenza For active immunisation of children IMP/BIO/19/000003 dated 1 Pharmaceuticals Limited, Vaccine (Surface from 6 to 35 months of age for the 04.04.2019 252, Dr. Annie Besant Antigen) I.P. prevention of influenza disease Road, Worli, Mumbai, (Quadrivalent) caused by the two influenza A virus Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines Maharashtra – 400030, subtypes and the two influenza B India. virus types contained in the vaccine . 2 M/s. Abbott India Limited, Inactivated Influenza Prophylaxis of influenza, especially IMP/BIO/19/000021 dated 2nd floor, unit no 3, Vaccine (Surface those who run an increased risk of 16.07.2019 Corporate Park Sion Antigen) I.P. associated complications. Inactivated Trombay road, Chembur, (Quadrivalent) Influenza Vaccine (Surface Antigen) Mumbai400071, I.P. (Quadrivalent) is indicated in Maharashtra, India adults (18 years of age and older) and children from 6 months of age Year-2017 S. No Name of Firm Name of Formulation Indication(s) Permission No. & Date 1 M/s Zuventus Healthcare Varicella Vaccine, For Active immunization against IMP-46/2017, dated: 01.03.2017 Ltd., Mumbai, India Live, I.P. (Oka Strain) Varicella Zoster in adults & infants of the age group of 12 months & above. 2 M/s Sanofi Healthcare India Quadrivalent Inactivated Quadrivalent Influenza IMP-119/2017, dated: 30.05.2017 Pvt. Ltd., Mumbai, India Inactivated Influenza vaccine indicated for the prevention of Vaccine (Split Virion) influenza disease caused by Influenza I.P. types A and B viruses contained in the vaccine and use in persons 18 years of age and older. 3 M/s MSD Pharmaceuticals Human Papillomavirus 1. Human Papillomavirus 9-valent IMP-121/2017, dated: 01.06.2017 Pvt. Ltd., Gurgaon, India 9-valent Vaccine, Vaccine, Recombinant is a vaccine Recombinant [ indicated in girls and women from 9 Serotypes: [Type 6 L1, years to 26 years age at 03 dose 11 L1, 16 L1, 18 L1, 31 regimen (schedule: 0, 2 & 6 months) for Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines L1, 33 L1, 45 L1, 52 L1 the prevention of cervical, vulvar, & 58 L1] vaginal and anal cancer; precancerous or dysplastic lesions; genital warts and persistent infections caused by Human Papillomavirus (HPV). 2. Human Papillomavirus 9-valent Vaccine, Recombinant is a vaccine indicated in boys from 9 years to 15 years at 03 dose regimen (schedule: 0, 2& 6 months) for the prevention of external genital lesions and persistent infections and the following diseases caused by HPV types included in the vaccine.  Anal Cancer caused by HPV Types caused by HPV types 16, 18, 31, 33, 45, 52 and 58.  Genital warts (Condyloma acuminate) caused by HPV types 6, 11.  And the following Precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.  Anal intraepithelial neoplasia (AIN) grades 1,2 and 3 grades 1,2 and 3 4 M/s GlaxoSmithKline Asia Diphtheria, Tetanus, Diphtheria, Tetanus, Pertussis IMP-122/2017, dated: 01.06.2017 Private limited, Mumbai, Pertussis (acellular (acellular component), Hepatitis B India component), Hepatitis (rDNA), Inactivated Poliomyelitis and B (rDNA), Inactivated Haemophilus influenza type b Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines Poliomyelitis and conjugate (adsorbed) [(DTaP-HBV-IPV) Haemophilus influenza + Hib] vaccine is indicated for primary type b conjugate and booster vaccination of infants vaccine (adsorbed) against diphtheria, tetanus, pertussis, [(DTaP-HBV-IPV) + hepatitis B, poliomyelitis and disease Hib] Vaccine caused by Haemophilus influenza type b. Year-2016 S. No Name of Firm Name of Indication Permission No. & Date Formulation 1 M/s Sanofi Healthcare DTaP-IPV-HepB-Hib- For primary and booster vaccination of IMP-53/2016,dated: 15.03.2016 India Pvt., Ltd. ,Mumbai, PRP-T vaccine infants and toddlers from 6 weeks to India 24 months of age against Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis and invasive diseases caused by Haemophilus influenza type b (Hib). 2 M/s Man mill Chemicals Inactivated Influenza For active Immunization against IMP-103/2016, dated: 30.06.2016 Pvt. Ltd., Mumbai, India vaccine (Spilt Virion) Susceptible Influenza. I.P. M/s MSD Pvt. Limited, 6th Human Indicated in girls and women 9-26 08.08.2016 3 & 7th floor Tower B, Papillomavirus years of age for prevention of Cervical Vartika tower, Sect-54, Quadrivalent (Type 6, cancer and Genital warts (condyloma Gurgaon 122002, India. 11, 16 & 18) Vaccine acuminate) caused by HPV type 6, 11, Recombinant (0.5 ml 16 and 18 vide permission dated single dose vial and 04.07.2008. Pre-Filled Syringes) Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines Further Post Approval Change for update in package insert for an alternative 2-dose regime for 9-13 years of age group to the existing approved 3 dose regimen for HPV vaccine 4 M/s GlaxoSmithKline Meningococcal A, C, For active immunization of children IMP-221/2016, dated: 22.12.2016 Pharmaceuticals Ltd., W-135 & Y Conjugate (from 2 years of age), adolescents and Mumbai, India vaccine adults to prevent invasive meningococcal disease caused by Neisseria Meningitidis A, C, W-135 and Y. Year-2015 S. No Name of Firm Name of Indication Permission No. & Date Formulation 1 M/s Prosper Channel Life Rabies Vaccine For active immunization against rabies IMP-133/2015,dated: 27.05.2015 Sciences, India virus for Human use only. 2 M/s Sinopharm India Private Varicella Vaccine For active immunization against IMP-145/2015,dated: 18.06.2015 Limited, Unit 403-404, 4th Varicella Zoster in adults & infants in floor Southern Park, Saket the age group of 12 months & above. District Centre, Tal Greater Kailash(50) Delhi- 110017,India Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines 3 M/s VHB Life Sciences ltd. Varicella vaccine For active immunization against IMP-170/2015,dated: 04.08.2015 ,India Varicella zoster in adults & infants in the age group of 12 months and above 4 M/s Novo-Medi Sciences Live Varicella The vaccine is indicated for the active IMP-183/2015, dated: 14.08.2015 Pvt. Ltd. ,India vaccine immunization against varicella vaccine of healthy, varicella susceptible subjects from age of 12 months. 5 M/s Serum Institute of India Inactivated Polio Active Immunization against IMP-231/2015, dated: 27.11.2015 Pvt. Ltd. ,India Vaccine Poliomyelitis. Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines Year-2014 S. No Name of Firm Name of Indication Permission No. & Date Formulation M/s MSD Pvt. Varicella For active immunization for the IMP-148/14 , dated: 03.07.2014 Limited, 6th & 7th vaccine prevention of varicella in individuals floor Tower B, from 12 months to 12 years of age. 1 Vartika tower, Sect- 54, Gurgaon 122002, India. MMRV vaccine For active immunization are IMP-163/2014, dated: 18.07.2014 M/s subjects from the age of 1 year to 12 GlaxoSmithKline 2 years of age inclusive against Pharmaceuticals Measles, Mumps, Rubella and Ltd., Mumbai, India varicella. M/s Pfizer India Pneumococcal For active immunization for the IMP-278, dated: 18.12.2014 Limited, Pfizer Saccharine prevention of disease caused by Centre, Patel conjugate Streptococcus Pneumoniae Estate, Jogeshwari vaccine serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 3 (W), Mumbai- adsorbed 13- 14, 18C, 19A, 19F and 23F 400102, India. valent (including species, Meningitis, Bacteraemia, pneumonia and acute Otitis media) in infants and children from 2 months to 5 years of age). Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines Year-2013 S. Name of Firm Name of Formulation Indication Permission No. & Date No. NIL Year-2012 S. No. Name of Firm Name of Molecule Indication Permission No. & Approved Date 1 M/s Sanofi Healthcare India Pvt. Meningococcal A C Y For active immunization of healthy 2 years to IMP-134/2012 dated: Ltd. and W-135 55 years age group for prevention of invasive 12.06. 2012 Polysaccharide meningococcal disease caused by Diphtheria Toxoid N.meningitides serogroups A, C, Y, and W- Conjugate 135. Year-2011 S. No. Name of Firm Name of Molecule Indication Permission No. & Date Approved 1 M/s HLL Life Care Ltd.(formerly Purified Rabies For active immunization against IMP-94/2011, dated: 22.03.2011 Hindustan Latex Limited), HILL Bhavan, vaccine (Vero cell ) Rabies for Human use only. for Human Use Pooojappura, Thiruvananthapuram Freeze dried ,Kerala, India 2 M/s GlaxoSmithKline Synflorix Active immunization of all infants IMP-102/2011, dated: 20.04.2011 Pharmaceuticals Ltd., Mumbai, [Pneumococcal and children from 6 weeks up to 5 India polysaccharide and years of age against diseases Non-Typeable caused by Streptococcus Haemophilus pneumonia serotypes 1, 4, 5, Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines influenzae(NTHi) 6B, 7F, 9V, 14, 18C, 19F and 23f protein D conjugate (including sepsis, meningitis, vaccine, adsorbed pneumonia, bacteremia and (10 Pn-PD-DiT)] acute otitis media) and against acute otitis media caused by Non Typeable Haemophilus influenzae. Year- 2010 S. Name of Firm Name of Molecule Indication Permission No. & Date No. Approved 1 M/s. Kiran Agencies, Purified Rabies vaccine For active immunization against IMP-205/10, dated: 09.03.2010 A/40, Kalayanji Morarji, (Vero cell Freeze dried) Rabies for Human use only. Warehousing Co. Ltd. Prem Industrial estate, Santa Savta Marg, Mazgoan, Mumbai,India 2 M/s Sanofi Healthcare India Influenza Inactivated, Split For active immunization for H1N1 IMP-222/10, dated: 12.03.2010 Pvt. Ltd., D-2, Fourth Floor, Virion, Non-Adjuvanted Pandemic Influenza Southern Park, DDA H1N1 vaccine. Commercial Centre, Saket- Delhi, India. 3 M/s Pfizer Ltd., Mumbai Pneumococcal For active immunization for the IMP-237-2010 dated: 23.03. 2010 Level 6 & 7, Platina, Plot No. C- Saccharide conjugate prevention of Pneumonia and 59, G-block, Bandra- Kurla vaccine (Adsorbed), 13 invasive disease caused by Complex, Bandra (East), valent Suspension streptococcus pneumonia serotypes Mumbai-400098,India 1,3,4,5,6A,6B,7F,9V,14,18C,19A,19F and 23F ( including species, meningitis, bacteremia, pneumonia and acute otitis media) in infants and children from 2 months to 5 years of age). Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines 4 M/s. MSD Pvt. Ltd. Rotavirus Vaccine Live Rota Teq is indicated for the IMP-339/10, dated: 28.04.2010 7th floor, Tower-B, Vatika (Oral) prevention of rotavirus gastroenteritis Towers, Sector-54, Gurgaon, in infants and children caused by the India serotypes G1, G2, G3 and G4 when administered as a 3 dose series to infants between 6 to 32 weeks. The first dose of Rota Teq should be administered between 6 to 12 weeks of age. 5 M/s Sun pharma Limited., Purified Rabies vaccine For active immunization against IMP-647/2010, dated: 22.09. 2010 Gurgaon ,India (Vero cell Freeze dried) Rabies for Human use only. Year-2009 S. Name of Firm Name of Molecule Approved Indication Permission No. & Date No. 1 M/s. GC Chemie Pharma Influenza Vaccine Split For active Immunization against Import-449/09, dated: 12.05. 2009 Ltd., 5/C, Shri Laxmi Indl. susceptible Influenza. Estate, New Link Road, Andheri (west), Mumbai, India. 2 M/s Synergy Diagnostics Rabies Vaccine (Freeze Dried) For active immunization against Import-810/09, dated: 21.10. 2009 Pvt. Ltd. 127/128, Laxmi (Vero Based) Rabies, both as prophylaxis and Market, Vartak Nagar, post bite cases. Thane, India Format. No. QMS-GNL-019/F01(b)-00