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Date: 2023-12-29 Category: Not Applicable State: Union Government Country: India

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Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The gazette notification provides details of import permissions granted for human vaccines from 2010 to 2023.
  • It lists the name of the firm, name of the formulation, indication(s), and permission number & date for each vaccine import permission.

Key Changes

  • In 2023, TechInvention Lifecare Pvt. Ltd. received permission (IMP/BIO/23/000044 dated 17-Apr-2023) to import Cholera Vaccine (Inactivated, Oral), I.P for prevention of Cholera in individuals from age 1 years and above caused by Vibrio cholerae.
  • In 2023, Prosper Channel Life Science India Pvt., Ltd received permission (IMP-30/2023 dated 21-April-2023) to import Hepatitis A vaccine (Human Diploid Cell) Inactivated for active immunization against Hepatitis A virus in 18-40 years of age group.
  • In 2023, Prosper Channel Life Science India Pvt., Ltd received permission (dated 27-July-.2023) to import Hepatitis A vaccine (Human Diploid Cell) Inactivated for active immunization against Hepatitis A virus in 1-15 years.
  • In 2022, Dr Reddy’s Laboratories Limited received permission (IMP/BIO/20/000067 dated 04-Feb-2022) to import Recombinant adenoviral vector vaccine containing particles of serotype 26 containing the protein S gene of the SARS-CoV-2virus for the prevention of COVID-19 in adults aged over 18 year, when administered in single dose of 0.5ml for restricted use in emergency situation.
  • In 2022, GlaxoSmithKline Pharmaceuticals Limited received permission (IMP/BIO/22/000014 dated 21-Feb-2022) to import Herpes Zoster Vaccine (Recombinant, Adjuvanted) for prevention of Herpes Zoster (HZ) and Post-Herpetic Neuralgia (PHN), in adults 50 years of age or older when administered in two doses of 0.5 ml each two months apart.
  • In 2022, Sanofi Healthcare India Private Limited received permission (dated 22.04.2022) to import Inactivated Quadrivalent Influenza Vaccine (Split Virion) I.P. for 0.5ml dose in the age group of 6 to 35months.
  • In 2022, GlaxoSmithKline Pharmaceuticals Limited received permission (BIO/IMP/21/000021 dated 06.05.2022) to import Inactivated Quadrivalent Influenza Vaccine (Split Virion) I.P., 0.5ml, single dose, prefilled syringe (PFS) for active immunization of adults and children from 6 months of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine.
  • In 2022, G. C. Chemie Pharmie Ltd. received permission (IMP/BIO/22/000065 dated 03.10.2022) to import Pneumococcal Polysaccharide Vaccine I.P.(23 valent ) for active immunization for the prevention of pneumococcal disease caused by the 23 serotype contained in the vaccine for use in adults aged 18 to 65 years when administered in single dose of 0.5 ml.
  • In 2021, Dr Reddy’s Laboratories Limited received permission (IMP/BIO/21/000011 dated 12-Apr-2021) to import Gam-COVID -Vac combined vector vaccine (Component I & Component II) for Restricted use in emergency situation: For the prevention of the novel Coronavirus infection (COVID-19) in adults aged over 18, when given in two separate doses three weeks apart. Day 0: Component I (0.5 ml) & Day 21: Component II (0.5ml).
  • In 2021, Pfizer Ltd. received additional indication (dated 17-May-2021) for Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) I.P., 13 valent for active immunization for the prevention of Pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in adults of 18 years to 49 years of age
  • In 2021, Cipla Limited received permission (IMP/BIO/21/000035 dated 29-Jun-2021) to import mRNA-1273 COVID-19 vaccine (Moderna) for Restricted use in emergency situation: For active immunization to prevent COVID-19 caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older when given in two doses (0.5 mL each) 28 days apart.
  • In 2021, Johnson & Johnson Pvt. Ltd. received permission (IMP/BIO/21/000048 dated 06-Aug-2021) to import COVID-19 vaccine (Ad26.COV2-S [recombinant]) for Restricted use in emergency situation: For active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older when given in single dose (0.5 mL).
  • In 2021, Dr. Reddy’s Laboratories Limited received permission (IMP/BIO/21/000090 dated 25-OCT-2021) to import Live Attenuated Hepatitis A Vaccine (Freeze-dried) for Active immunization against Hepatitis A in adults and children Above one year age.
  • In 2021, Glaxosmithkline Pharmaceuticals Limited received permission (IMP/BIO/21/000099 dated 08-Dec-2021) to import Rotavirus Vaccine (Live Attenuated, Oral) I.P. for active immunization of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection (Dose schedule 0,1 month)
  • In 2020, Sinopharm India Private Limited received permission (IMP/BIO/20/000067 dated 03.09.2020) to import Hepatitis A (Live) vaccine, Freeze dried virus to prevent Hepatitis A in age group of 1 to 12 years.
  • In 2020, Zuventus HealthcareLtd. received permission (IMP/BIO/20/000002 dated 14.02.2020) to import Rabies Vaccine, Human, IP (Vero Cell), (Freeze Dried) for Pre-exposure prophylaxis and post exposure prophylaxis of Rabies. As per following schedule Pre-exposure prophylaxis : Day0, Day7 & Day28 Post exposure prophylaxis : Day 0, Day 3, Day 7, Day 14 & Day 28
  • In 2019, GlaxoSmithKline Pharmaceuticals Limited received permission (IMP/BIO/19/000003 dated 04.04.2019) to import Inactivated Influenza Vaccine (Surface Antigen) I.P. (Quadrivalent) for active immunisation of children from 6 to 35 months of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine.
  • In 2019, Abbott India Limited received permission (IMP/BIO/19/000021 dated 16.07.2019) to import Inactivated Influenza Vaccine (Surface Antigen) I.P. (Quadrivalent) for Prophylaxis of influenza, especially those who run an increased risk of associated complications. Inactivated Influenza Vaccine (Surface Antigen) I.P. (Quadrivalent) is indicated in adults (18 years of age and older) and children from 6 months of age
  • In 2017, Zuventus Healthcare Ltd. received permission (IMP-46/2017, dated: 01.03.2017) to import Varicella Vaccine, Live, I.P. (Oka Strain) for Active immunization against Varicella Zoster in adults & infants of the age group of 12 months & above.
  • In 2017, Sanofi Healthcare India Pvt. Ltd. received permission (IMP-119/2017, dated: 30.05.2017) to import Quadrivalent Inactivated Influenza Vaccine (Split Virion) I.P. for the prevention of influenza disease caused by Influenza types A and B viruses contained in the vaccine and use in persons 18 years of age and older.
  • In 2017, MSD Pharmaceuticals Pvt. Ltd. received permission (IMP-121/2017, dated: 01.06.2017) to import Human Papillomavirus 9-valent Vaccine, Recombinant for the prevention of cervical, vulvar, vaginal and anal cancer; precancerous or dysplastic lesions; genital warts and persistent infections caused by Human Papillomavirus (HPV) in girls and women from 9 years to 26 years age at 03 dose regimen (schedule: 0, 2 & 6 months) and 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.
  • In 2017, GlaxoSmithKline Asia Private limited received permission (IMP-122/2017, dated: 01.06.2017) to import Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B (rDNA), Inactivated Poliomyelitis and Haemophilus influenza type b conjugate (adsorbed) [(DTaP-HBV-IPV) + Hib] vaccine is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenza type b.
  • In 2016, Sanofi Healthcare India Pvt., Ltd. received permission (IMP-53/2016,dated: 15.03.2016) to import DTaP-IPV-HepB-Hib-PRP-T vaccine for primary and booster vaccination of infants and toddlers from 6 weeks to 24 months of age against Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis and invasive diseases caused by Haemophilus influenza type b (Hib).
  • In 2016, Man mill Chemicals Pvt. Ltd. received permission (IMP-103/2016, dated: 30.06.2016) to import Inactivated Influenza vaccine (Spilt Virion) I.P. for active Immunization against Susceptible Influenza.
  • In 2016, MSD Pvt. Limited received permission (dated 08.08.2016) to import Human Papillomavirus Quadrivalent (Type 6, 11, 16 & 18) Vaccine Recombinant (0.5 ml single dose vial and Pre-Filled Syringes) Indicated in girls and women 9-26 years of age for prevention of Cervical cancer and Genital warts (condyloma acuminate) caused by HPV type 6, 11, 16 and 18. 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
  • In 2016, GlaxoSmithKline Pharmaceuticals Ltd. received permission (IMP-221/2016, dated: 22.12.2016) to import Meningococcal A, C, W-135 & Y Conjugate vaccine for active immunization of children (from 2 years of age), adolescents and adults to prevent invasive meningococcal disease caused by Neisseria Meningitidis A, C, W-135 and Y.
  • In 2015, Prosper Channel Life Sciences received permission (IMP-133/2015,dated: 27.05.2015) to import Rabies Vaccine for active immunization against rabies virus for Human use only.
  • In 2015, Sinopharm India Private Limited received permission (IMP-145/2015,dated: 18.06.2015) to import Varicella Vaccine for active immunization against Varicella Zoster in adults & infants in the age group of 12 months & above.
  • In 2015, VHB Life Sciences ltd. received permission (IMP-170/2015,dated: 04.08.2015) to import Varicella vaccine for active immunization against Varicella zoster in adults & infants in the age group of 12 months and above
  • In 2015, Novo-Medi Sciences Pvt. Ltd. received permission (IMP-183/2015, dated: 14.08.2015) to import Live Varicella vaccine for the active immunization against varicella vaccine of healthy, varicella susceptible subjects from age of 12 months.
  • In 2015, Serum Institute of India Pvt. Ltd. received permission (IMP-231/2015, dated: 27.11.2015) to import Inactivated Polio Vaccine for Active Immunization against Poliomyelitis.
  • In 2014, MSD Pvt. Limited received permission (IMP-148/14 , dated: 03.07.2014) to import Varicella vaccine for active immunization for the prevention of varicella in individuals from 12 months to 12 years of age.
  • In 2014, GlaxoSmithKline Pharmaceuticals Ltd. received permission (IMP-163/2014, dated: 18.07.2014) to import MMRV vaccine for active immunization are subjects from the age of 1 year to 12 years of age inclusive against Measles, Mumps, Rubella and varicella.
  • In 2014, Pfizer India Limited received permission (IMP-278, dated: 18.12.2014) to import Pneumococcal Saccharine conjugate vaccine adsorbed 13- valent for active immunization for the prevention of disease caused by Streptococcus Pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (including species, Meningitis, Bacteraemia, pneumonia and acute Otitis media) in infants and children from 2 months to 5 years of age).
  • In 2012, Sanofi Healthcare India Pvt. Ltd. received permission (IMP-134/2012 dated: 12.06. 2012) to import Meningococcal A C Y and W-135 Polysaccharide Diphtheria Toxoid Conjugate for active immunization of healthy 2 years to 55 years age group for prevention of invasive meningococcal disease caused by N.meningitides serogroups A, C, Y, and W-135.
  • In 2011, HLL Life Care Ltd. received permission (IMP-94/2011, dated: 22.03.2011) to import Purified Rabies vaccine (Vero cell ) for Human Use Freeze dried for active immunization against Rabies for Human use only.
  • In 2011, GlaxoSmithKline Pharmaceuticals Ltd. received permission (IMP-102/2011, dated: 20.04.2011) to import Synflorix [Pneumococcal polysaccharide and Non-Typeable Haemophilus influenzae(NTHi) protein D conjugate vaccine, adsorbed (10 Pn-PD-DiT)] Active immunization of all infants and children from 6 weeks up to 5 years of age against diseases caused by Streptococcus pneumonia serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23f (including sepsis, meningitis, pneumonia, bacteremia and acute otitis media) and against acute otitis media caused by Non Typeable Haemophilus influenzae.
  • In 2010, Kiran Agencies received permission (IMP-205/10, dated: 09.03.2010) to import Purified Rabies vaccine (Vero cell Freeze dried) for active immunization against Rabies for Human use only.
  • In 2010, Sanofi Healthcare India Pvt. Ltd. received permission (IMP-222/10, dated: 12.03.2010) to import Influenza Inactivated, Split Virion, Non-Adjuvanted for active immunization for H1N1 Pandemic Influenza H1N1 vaccine.
  • In 2010, Pfizer Ltd. received permission (IMP-237-2010 dated: 23.03. 2010) to import Pneumococcal Saccharide conjugate vaccine (Adsorbed), 13 valent Suspension for active immunization for the prevention of Pneumonia and invasive disease caused by streptococcus pneumonia serotypes 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).
  • In 2010, MSD Pvt. Ltd. received permission (IMP-339/10, dated: 28.04.2010) to import Rotavirus Vaccine Live (Oral) Rota Teq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the 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.
  • In 2010, Sun pharma Limited. received permission (IMP-647/2010, dated: 22.09. 2010) to import Purified Rabies vaccine (Vero cell Freeze dried) for active immunization against Rabies for Human use only.
  • In 2009, GC Chemie Pharma Ltd. received permission (Import-449/09, dated: 12.05. 2009) to import Influenza Vaccine Split for active Immunization against susceptible Influenza.
  • In 2009, Synergy Diagnostics Pvt. Ltd. received permission (Import-810/09, dated: 21.10. 2009) to import Rabies Vaccine (Freeze Dried) (Vero Based) for active immunization against Rabies, both as prophylaxis and post bite cases.

Impact Analysis

Vaccine Manufacturers/Importers

  • Action Item: Review the list to identify opportunities for new vaccine introductions or increased market share.

Healthcare Providers

  • Action Item: Update vaccine inventory and protocols based on the list of approved vaccines.

Patients

  • Action Item: Consult with healthcare providers about appropriate vaccination schedules.

Government and Regulatory Bodies

  • Action Item: Use the data to assess vaccination coverage and identify areas for improvement.

Key Entities Referenced

M/s TechInvention Lifecare Pvt. Ltd: Importer of Cholera Vaccine in 2023 M/s Prosper Channel Life Science India Pvt., Ltd: Importer of Hepatitis A vaccine in 2023 M/s Dr Reddy’s Laboratories Limited: Importer of Recombinant adenoviral vector vaccine (COVID-19) in 2022 and Gam-COVID -Vac (COVID-19) in 2021 and Hepatitis A Vaccine in 2021 M/s GlaxoSmithKline Pharmaceuticals Limited: Importer of Herpes Zoster Vaccine in 2022, Inactivated Quadrivalent Influenza Vaccine in 2022, Rotavirus Vaccine in 2021, Inactivated Influenza Vaccine in 2019, Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B (rDNA), Inactivated Poliomyelitis and Haemophilus influenza type b conjugate vaccine in 2017, Meningococcal A, C, W-135 & Y Conjugate vaccine in 2016, MMRV vaccine in 2014 and Synflorix in 2011 M/s Sanofi Healthcare India Private Limited: Importer of Inactivated Quadrivalent Influenza Vaccine in 2022, Quadrivalent Inactivated Influenza Vaccine in 2017, DTaP-IPV-HepB-Hib-PRP-T vaccine in 2016, Meningococcal A C Y and W-135 in 2012 and Influenza Inactivated, Split Virion, Non-Adjuvanted in 2010 M/s G. C. Chemie Pharmie Ltd.: Importer of Pneumococcal Polysaccharide Vaccine in 2022 and Influenza Vaccine Split in 2009 M/s Pfizer Ltd.: Importer of Pneumococcal Polysaccharide Conjugate Vaccine in 2021, Pneumococcal Saccharide conjugate vaccine in 2014 and Pneumococcal Saccharide conjugate vaccine in 2010 M/s Cipla Limited: Importer of mRNA-1273 COVID-19 vaccine (Moderna) in 2021 M/s. Johnson & Johnson Pvt. Ltd.: Importer of COVID-19 vaccine (Ad26.COV2-S [recombinant]) in 2021 M/s Sinopharm India Private Limited: Importer of Hepatitis A (Live) vaccine in 2020 and Varicella Vaccine in 2015 M/s Zuventus HealthcareLtd.: Importer of Rabies Vaccine in 2020 and Varicella Vaccine in 2017 M/s. Abbott India Limited: Importer of Inactivated Influenza Vaccine in 2019 M/s MSD Pharmaceuticals Pvt. Ltd.: Importer of Human Papillomavirus 9-valent Vaccine in 2017, Human Papillomavirus Quadrivalent Vaccine in 2016, Varicella vaccine in 2014 and Rotavirus Vaccine Live in 2010 M/s Man mill Chemicals Pvt. Ltd.: Importer of Inactivated Influenza vaccine in 2016 M/s Prosper Channel Life Sciences: Importer of Rabies Vaccine in 2015 M/s VHB Life Sciences ltd.: Importer of Varicella vaccine in 2015 M/s Novo-Medi Sciences Pvt. Ltd.: Importer of Live Varicella vaccine in 2015 M/s Serum Institute of India Pvt. Ltd.: Importer of Inactivated Polio Vaccine in 2015 M/s HLL Life Care Ltd.: Importer of Purified Rabies vaccine in 2011 M/s. Kiran Agencies: Importer of Purified Rabies vaccine in 2010 M/s Sun pharma Limited.: Importer of Purified Rabies vaccine in 2010 M/s Synergy Diagnostics Pvt. Ltd.: Importer of Rabies Vaccine in 2009
Official Source Record View Original Source →
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Annexure-I(b) Details of Import Permissions of Human Vaccines Year-2023 S. No Name of Firm Name of Formulation Indication(s) Permission No. & Date 1 M/s TechInvention Cholera 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 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. Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines 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 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 Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines 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. 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. Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines 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 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 Format. No. QMS-GNL-019/F01(b)-00Annexure-I(b) Details of Import Permissions of Human Vaccines 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

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