Status of Import Permission (Form 45) of Vaccine from 2009 to 14th November 2013.

S.No. / Name of Firm / Name of Molecule Approved / Indication / Date
1 / M/s. GC Chemie Pharma Ltd., 5/C, Shri Laxmi Indl. Estate, New LinkRoad, Andheri (west), Mumbai. / Influenza Vaccine Split / For active Immunization against susceptible Influenza. / Permission no. Import-449/09,12th May, 2009
2 / M/s Synergy Diagnostics Pvt. Ltd. 127/128, Laxmi Market, Vartak Nagar, Thane. / Rabies Vaccine (Freezed Dried) (Vero Based) / For active immunization against Rabies, both as prophylaxis and post bite cases. / Permission no. Import-810/09, 21st Oct, 2009
3 / M/s. Kiran Agencies,
A/40, Kalayanji Morarji, Warehousing Co. Ltd. Prem Industrial estate, Santa Savta Marg, Mazgoan, Mumbai- / Purified Rabies vaccine (Vero cell Freezed dried) / For active immunization against Rabies for Human use only. / Permission no. IMP-205/10, 09th March, 2010
4 / M/s Sanofi Pasteur India Pvt. Ltd., D-2, Fourth Floor, Southern Park, DDA Commercial Centre, Saket- Delhi / Influenza Inactivated, Split Virion, Non-Adjuvanted H1N1 vaccine. / For active immunization for H1N1 Pandemic Influenza / Permission no. IMP-222/10, 12th March, 2010
5 / M/s Wyeth Ltd., Mumbai
Level 6 & 7, Platina, Plot No. C-59, G-block, Bandra-Kurla Complex, Bandra (East), Mumbai-400098 / 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, meninggitis, bacteraemia, pneumonia and acute otitis media) in infants and children from 2 months to 5 years of age). / Permission no. IMP-237-2010 dated 23th March 2010
6 / M/s Nirlac Chemicals, 14th floor, Nirmal Building, 241/242, Nariman Point, Mumbai / Oral Poliomyelitis (Type 1) Vaccine Monovalent / For active immunization against poliomyelitis type I. / Permission no. IMP-1066/08, 12th April, 2010
7 / M/s. MSD Pvt. Ltd.
7th floor, Tower-B, Vatika Towers, Sector-54, Gurgaon / Rotavirus Vaccine Live Oral Pantavalent / Rota Teq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by th 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. / Permission no. IMP-339/10, 28th April, 2010
8 / M/s Ranbaxy Laboratories Ltd., Plot No. 90, Sector 32, Gurgaon / Purified Rabies vaccine (Vero cell Freezed dried) / For active immunization against Rabies for Human use only. / Permission no. IMP-647/2010, 22nd Sep, 2010
9 / M/s HLL Life Care Ltd.(formerly Hindustan Latex Limited), HILL Bhavan, Pooojappura, Thiruvananthapuram, Kerala / Purified Rabies vaccine (vero cell ) for Human Use Freeze dried / For active immunization against Rabies for Human use only. / Permission no. IMP-94/2011, 22nd March 2011
10 / M/s GlaxoSmithKline Pharmaceuticals Ltd., Mumbai / 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, bacteraemia and acute otitis media) and against acute otitis media caused by Non Typeable Haemophilus influenzae. / Permission no. IMP-102/2011, 20th Apr 2011
11 / M/s Novartis Healthcare Pvt. Ltd., Sandoz House, Dr. Annie Besant Road, Worli, Mumbai. / Recombinant Hepatitis-B Vaccine (Sci-B-Vac) from / For active immunization against Hepatitis B virus. / Permission no. IMP-254/11, 2nd June 2011
12 / M/s Sanofi Pasteur India Pvt. Ltd., 54/A, Sir Mathuradas Vasanji Road, Andheri East, Mumabi-400093 / 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. / Permission No. IMP-134/2012 dated 12th June 2012
13 / M/s. Wockhardt Limited Wockhardt Towers, Bandra Kurla Complex, Bandra (East), Mumbai 400051 / Freeze Dried Live Attenuated Hepatitis – A Vaccine / Active immunization against Hepatitis A in adults & Children above one year age. / Permission no. IMP -101/2013, dated; 25 Jun 2013
14 / M/s Novartis Healthcare Pvt. Ltd, Vaccine Division division, 501, Shree Amba Shanti Chambers, Andheri Kurla Road, Andheri-East, Mumbai-400059 / Influenza vaccine, surface antigen, inactivated / For Active immunization against influenza (flu), especially in those who run an increased risk of associated complications. / Permission no. IMP-139/2013, dated 26th Jun 2013.
15. / Novartis Healthcare Pvt. Ltd., Vaccines Division, Andheri east, Mumbai-400 059 / Quinvaxem (DTwP-Hib-Hep B vaccine) / Paediatric combination vaccine against diphtheria, tetanus, pertussis, hepatitis B and disease caused by Haemophilus influenzae type b. / Permission No. IMP-189/2013 dated:30th Aug 2013

Status of Bulk Import permission (Form 45 A) of Vaccine

S.No. / F.No. / Name of Firm / Imported from / Name of Molecule Approved / Date
1. / 12-52/Panacea/12-BD / M/s Panacea Biotec ltd., New Delhi. / M/s P.T. Bio-Farma, Indonesia / Diphtheria Toxoid concentrate, Tetanus Toxoid concentrate & whole cell Pertussis concentrate / Bulk -105/2013 dated 29.04.2013
2. / 12-65/GSK/11-BD (VIRAL) / M/s GlaxoSmithKline Asia Pvt Ltd., A-10/1, M.I.D.C. Ambad-Pathardi Phara, Ambad, Nashik-422010 / M/s GlaxoSmithKline Biologicals S.A., Rue de l’Institit 89, B-1330 Rixensart, Belgium / Purified Hepatitis B surface antigen bulk vaccine / Permission no. BULK-68/2013 dated 09 Sep 2013