Regulations for the issue of Lot Release Certificate for Vaccines & Sera No.1 of 2019
Application form for Lot Release certificate for Vaccines & Sera
Application form for Quality Testing of Vaccines & Sera
Temperature monitoring data during transportation of Vaccines & Sera
|
Serial |
Product Name | Manufacture | Lot No | Manufacturing date | Expiry date | Lot release certificate No | Date of release | No of vials released |
| 1 | Varicella Vaccine (live), Varilrix Single dose vial | GlaxoSmithKline Biologicals Rixensart, Belgium | A70CD366A | Mar 2019 | Feb 2021 | 44/2019/LR | 05.02.2120 | 500 |
| 2 | Inactivated Poliomyelitis vaccine 05 dose vial (25 dose as ID adm) | Bilthoven Biologicals B.V.,The Netherlands |
1913005A, 1922002A, 1941002A |
19.03.2019, 26.04.2019, 29.08.2019 |
18.03.2022, 23.04.2022, 22.08.2022 |
51/2019/LR | 06.01.2020 |
119, 4923, 17918 |
| 3 | Adsorbed Tetanus Vaccine B.P.Single dose vial | Serum Institute of India Pvt. Ltd.,India |
25991003A, 25991003B |
Feb 2019 | Jan 2022 | 01/2020/LR | 16.01.2020 |
160500, 139500 |
| 4 | Rabies Vaccine for Human Use (vero cell) freeze dried, SPEEDA | Liaoning Cheng Da Biotechnology Co., Ltd., China. | 201905141 | May 2019 | Apr 2022 | 02/2020/LR | 22.01.2020 | 55000 |
| 5 | Hepatitis B Vaccine (rDNA) Single dose vial | Serum Institute of India Pvt. Ltd.,India | 0349Q001C | Jan 2019 | Dec 2021 | 03/2020/LR | 16.01.2020 | 25000 |
| 6 | Rabies Vaccine B.P. 'Rab' Abhayrab Purified vero cell rabies vaccine | Human Biologicals Institute (A division of Indian Immunologicals Ltd), India |
19URAB068, 19URAB073 |
Aug 2019 | Jul 2022 | 04/2020/LR | 21.01.2020 |
39627, 15373 |
| 7 | Rabies Vaccine for Human Use (vero cell) freeze dried, SPEEDA | Liaoning Cheng Da Biotechnology Co., Ltd., China. |
201905141, 201908258 |
May 2019 Aug 2019 | Apr 2022 Jul 2022 | 05/2020/LR | 07.02.2020 |
33640, 31360 |
| 8 | Measles, Mumps and Rubella vaccine,Live, Attenuated (Freeze-dried)10 dose vial | Serum Institute of India Pvt. Ltd.,India | 0168N024 | Jun 2019 | Nov 2021 | 06/2020/LR | 27.02.2020 | 40000 |
| 9 | Rabies Vaccine for Human Use (vero cell) freeze dried, SPEEDA | Liaoning Cheng Da Biotechnology Co., Ltd., China. | 201908260 | Aug 2019 | Jul 2022 | 07/2020/LR | 11.03.2020 | 60000 |
| 10 | BCG Vaccine 20 dose vial | Serum Institute of India Pvt. Ltd.,India | 0379G087 | Nov 2019 | Oct 2021 | 08/2020/LR | 04.03.2020 | 20000 |
| 11 | Diphtheria and Tetanus Vaccine Adsorbed for adult and adolescents 10 dose vial | Serum Institute of India Pvt. Ltd.,India | 2339X029A | Oct 2019 | Sep 2022 | 09/2020/LR | 04.03.2020 | 20000 |
| 12 | Rabies Vaccine for Human Use (vero cell) freeze dried, SPEEDA | Liaoning Cheng Da Biotechnology Co., Ltd., China. |
201908260 ,201908262 |
Aug 2019 | Jul 2022 | 10/2020/LR | 15.05.2020 |
26220 ,28780 |
| 13 | Hepatitis B Vaccine (rDNA) Single dose vial | Serum Institute of India Pvt. Ltd.,India | 0349Q007C | Sep 2019 | Aug 2022 | 11/2020/LR | 11.05.2020 | 23000 |
| 14 | Human Papillomavirus Quadrivalent Vaccine, Gardasil Single dose vial | Merck Sharp & Dohme Corp.,USA | S036739 | 25.02.2019 | 25.02.2022 | 12/2020/LR | 10.06.2020 | 75000 |
| 15 | Diphtheria and Tetanus Vaccine Adsorbed for adult and adolescents 10 dose vial | Serum Institute of India Pvt. Ltd.,India | 2339L032C | Dec 2019 | Nov 2022 | 13/2020/LR | 11.06.2020 | 20000 |
| 16 | Diphtheria, Tetanus and Pertussis Vaccine Adsorbed 10 dose vial | Serum Institute of India Pvt.Ltd.,India | 2829X022A | Jan 2020 | Dec 2021 | 14/2020/LR | 11.06.2020 | 20000 |
| 17 | Japanese Encephalitis Vaccine, Live 5 dose vial | Chengdu Institute of Biological Products Co. Ltd., China | 201911C053-2 | 23.11.2019 | 22.11.2021 | 15/2020/LR | 15.06.2020 | 50000 |
| 18 | Rabies Vaccine B.P. 'Rab' Abhayrab Purified vero cell rabies vaccine | Human Biologicals Institute (A division of Indian Immunologicals Ltd), TamilNadu, India |
19URAB093, 19URAB109, 20URAB004, 20URAB006 |
Nov 2019, Jan 2020, Jan 2020, Jan 2020 |
Oct 2022 Dec 2022 Dec 2022 Dec 2022 | 16/2020/LR | 11.06.2020 | 22418 70305 70298 16979 |
No. of vaccine/serum lots released = 27
No. of vaccine/serum lots failed to pass lot release = 0
No. of vaccine/serum lots tested following a break in the cold chain, adverse effects following immunization or vaccine failure = 0
| Sr. No | Product Name | Manufacture | Lot No | Manufacturing date | Expiry date | Lot release certificate No | Date of release |
| 1 | Varicella Vaccine - Varilrix | Glaxo SmithKline Biologicals, Belgium | A70CD239A | Mar 2018 | Feb 2020 | 42/2018/LR | 01.01.2019 |
| 2 | Meningococcal (Groups A,C,Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine - Menactra | Sanofi Pasteur Inc, USA | U5961AG | 14.07.2017 | 21.07.2019 | 27/2018/LR | 03.01.2019 |
| 3 | Rabies Vaccine B.P. 'Rab' - Abhayrab Purified vero cell rabies vaccine | Human Biologicals Institute, India | 18URAB094 | Nov 2018 | Oct 2021 | 01/2019/LR | 14.01.2019 |
| 4 | Rabies Vaccine B.P. 'Rab' - Abhayrab Purified vero cell rabies vaccine | Human Biologicals Institute, India | 18URAB099 | Nov 2018 | Oct 2021 | 02/2019/LR | 31.01.2019 |
| 5 | Rabies Vaccine B.P. 'Rab' - Abhayrab Purified vero cell rabies vaccine | Human Biologicals Institute, India | 18URAB099 | Nov 2018 | Oct 2021 | 03/2019/LR | 15.02.2019 |
| 6 | Rabies Vaccine B.P. 'Rab' - Abhayrab Purified vero cell rabies vaccine | Human Biologicals Institute, India | 18URAB103 | Dec 2018 | Nov 2021 | 03/2019/LR | 15.02.2019 |
| 7 | Rabies Vaccine for Human Use (Vero Cell), Freeze-dried - SPEEDA | Liaoning Cheng Da Biotechnology Co., Ltd., China. | 201712427 | Dec 2017 | Nov 2020 | 04/2019/LR | 21.02.2019 |
| 8 | Yellow Fever Vaccine (Live) | Sanofi Pasteur S A, France | R3C963V | 22.03.2018 | 02-2021 | 05/2019/LR |
25.02.2019 |
| 9 | Bivalent Oral Poliomyelitis Vaccine | Sanofi Pasteur S A, France | R3D60 | 06.04.2018 | 31.03.2020 | 06/2019/LR | 25.02.2020 |
| 10 | Rabies Vaccine B.P. 'Rab' - Abhayrab Purified vero cell rabies vaccine | Human Biologicals Institute, India | 18URAB109 | Dec 2018 | Nov 2021 | 07/2019/LR | 10.04.2019 |
| 11 | Rabies vaccine, Verorab | Sanofi Pasteur, France | R1B97IV | 03.04.2018 | Mar 2021 | 08/2019/LR | 24.06.2019 |
| 12 | Rabies Vaccine B.P. 'Rab' - Abhayrab Purified vero cell rabies vaccine | Human Biologicals Institute, India | 19URAB005 | Jan 2019 | Dec 2021 | 09/2019/LR | 09.04.2019 |
| 13 | Rabies antiserum, Equine origin - Equirab 1000 IU/5 mL | Bharat Serums and Vaccines Ltd., India | A06818010 | 03/2018 | 02/2020 | 10/2019/LR | 17.04.2019 |
| 14 | Rabies antiserum, Equine origin - Equirab 1000 IU/5 mL | Bharat Serums and Vaccines Ltd., India | A06818011 | 03/2018 | 02/2020 | 10/2019/LR | 17.04.2019 |
| 15 | Rabies antiserum, Equine origin - Equirab 1000 IU/5 mL | Bharat Serums and Vaccines Ltd., India | A06818020 | 07/2018 | 06/2020 | 10/2019/LR | 17.04.2019 |
| 16 | Rabies antiserum, Equine origin - Equirab 1000 IU/5 mL | Bharat Serums and Vaccines Ltd., India | A06818021 | 07/2018 | 06/2020 | 10/2019/LR | 17.04.2019 |
| 17 | Rabies antiserum, Equine origin - Equirab 1000 IU/5 mL | Bharat Serums and Vaccines Ltd., India | A06818024 | 08/2018 | 07/2020 | 10/2019/LR | 17.04.2019 |
| 18 | Rabies antiserum, Equine origin - Equirab 1000 IU/5 mL | Bharat Serums and Vaccines Ltd., India | A06818026 | 09/2018 | 08/2020 | 10/2019/LR | 17.04.2019 |
| 19 | Rabies antiserum, Equine origin - Equirab 1000 IU/5 mL | Bharat Serums and Vaccines Ltd., India | A06818027 | 09/2018 | 08/2020 | 10/2019/LR | 17.04.2019 |
| 20 | Human Papillomavirus Quadrivalent Vaccine - Gardasil | Merck Sharp and Dohme Corp, USA | S002318 | 27.06.2018 | 27.06.2021 | 11/2019/LR | 06.05.2019 |
| 21 | Inactivated Poliomyelitis vaccine | Bilthoven Biologicals B.V., The Netherlands | 1901009A | 06.12.2018 | 19.11.2021 | 12/2019/LR | 13.05.2019 |
| 22 | Inactivated Poliomyelitis vaccine | Bilthoven Biologicals B.V., The Netherlands | 1903001A |
10.01.2019 |
17.12.2021 | 12/2019/LR | 13.05.2019 |
| 23 | Inactivated Poliomyelitis vaccine | Bilthoven Biologicals B.V., The Netherlands | 1904002A |
14.01.2019 |
28.11.2021 | 12/2019/LR | 13.05.2019 |
| 24 |
Inactivated Poliomyelitis vaccine |
Bilthoven Biologicals B.V., The Netherlands | 1904003A |
15.01.2019 |
28.11.2021 | 12/2019/LR | 13.05.2019 |
| 25 |
Rabies antiserum, Equine origin - Equirab 1000 IU/5 mL |
Bharat Serums and Vaccines Ltd., India | A06818009 |
03/2018 |
02/2020 | 13/2019/LR | 09.05.2019 |
| 26 |
Diphtheria, Tetanus and Pertussis Vaccine Adsorbed |
Serum Institute of India Pvt.Ltd., India |
2828X010B |
Nov 2018 |
Oct 2020 | 14/2019/LR | 22.05.2019 |
| 27 |
Dephtheria and Tetanus Vaccine, Adsorbed (Pediatric) |
Serum Institute of India Pvt.Ltd., India |
2458L003A |
Dec 2018 |
Nov 2021 | 15/2019/LR | 22.05.2019 |
| 28 |
Diphtheria and Tetanus Vaccine Adsorbed for adult and adolescents |
Serum Institute of India Pvt.Ltd., India |
2338L024A |
Nov 2018 |
Oct 2021 | 16/2019/LR | 22.05.2019 |
| 29 |
Rabies Vaccine for Human Use (Vero Cell), Freeze-dried - SPEEDA |
Liaoning Cheng Da Biotechnology Co., Ltd., China. |
201809279 |
Sep 2018 |
Aug 2021 | 17/2019/LR | 24.05.2019 |
| 30 |
Rabies Vaccine B.P. 'Rab' - Abhayrab Purified vero cell rabies vaccine |
Human Biologicals Institute, India |
19URAB010 |
Feb 2019 |
Jan 2022 | 18/2019/LR | 30.05.2019 |
| 31 |
Pneumococcal Vaccine, polyvalent - Pneumovax*23 |
Merck Sharp and Dohme Corp, U.S.A. |
S007700 |
01.09.2018 |
01.09.2020 | 19/2019/LR | 10.06.2019 |
| 32 |
BCG Vaccine |
Serum Institute of India Pvt.Ltd., India |
0378G154 |
Jan 2019 |
Dec 2020 | 20/2019/LR | 24.06.2019 |
| 33 |
Japanese Encephalitis Vaccine, Live |
Chengdu Institute of Biological Products Co. Ltd., China |
201901C001-2 |
04.01.2019 |
03.01.2021 | 21/2019/LR | 24.06.2019 |
| 34 |
Hepatitis B vaccine (rDNA) |
Serum Institute of India Pvt.Ltd., India |
0348Y017C |
Oct 2018 |
Sep 2021 | 23/2019/LR | 24.06.2019 |
| 35 |
Snake Venom Antiserum I.P. |
Bharat Serums and Vaccines Ltd, India |
A05317153 |
Oct 2017 |
Sep 2021 | 24/2019/LR | 24.06.2019 |
| 36 |
Snake Venom Antiserum I.P. |
Bharat Serums and Vaccines Ltd, India |
A05317154 |
Oct 2017 |
Sep 2021 | 24/2019/LR | 24.06.2019 |
| 37 |
Snake Venom Antiserum I.P. |
Bharat Serums and Vaccines Ltd, India |
A05317155 |
Oct 2017 |
Sep 2021 | 24/2019/LR | 24.06.2019 |
| 38 |
Hepatitis B vaccine (rDNA) |
Serum Institute of India Pvt.Ltd., India |
0348X008FE |
Jul 2018 |
Jun 2021 | 25/2019/LR | 25.06.2019 |
|
No. of vaccine/serum lots released = 38 No. of vaccine/serum lots failed to pass lot release = 0 No. of vaccine/serum lots tested following a break in the cold chain, adverse effects following immunization or vaccine failure = 0
|
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| Serial No | Product Name | Manufacture | Lot No | Manufacturing date | Expiry date | Lot release certificate No | Date of release | No of vials released |
| Meningococcal (Group A,C,Y, W-135) Polysacharide Diphtheria Toxoid Conjugate Vaccine - Menactra Single dose vial | Sanofi Pasteur Inc., USA | U6131AE | 24.01.2018 | 13.02.2020 | 22/2019/LR | 31.07.2019 | 2,000 | |
| 1 | Meningococcal (Group A,C,Y, W-135) Polysacharide Diphtheria Toxoid Conjugate Vaccine - Menactra Single dose vial | Sanofi Pasteur Inc., USA | U6366AH | 11.09.2018 | 26.09.2020 | 26/2019/LR | 31.07.2019 | 1,500 |
| 2 | Rabies Vaccine B.P. 'Rab' Abhayrab Purified vero cell rabies vaccine ID administration 5 dose vial (IM administration single dose vial) | Human Biologicals Institute, India | 19URAB022 | Mar 2019 | Feb 2022 | 27/2019/LR | 09.07.2019 | 40,000 |
| 3 | Adsorbed tetanus vaccine B.P.Single dose vial | Biological E Ltd., India | 220801718C 220801818A 220801818D |
Jul 2018 Aug 2018 Aug 2018 |
Jun 2021 Jul 2021 Jul 2021 |
28/2019/LR | 09.07.2019 |
10,000 92,420 94,631 |
| 4 | Rabies antiserum, Equine origin - Equirab 1000 IU/5 mL | Bharat Serums and Vaccines Ltd., India | A06819003 | Jan 2019 | Dec 2020 | 29/2029/LR | 07.08.2019 | 20,000 |
| 5 | Yellow Fever Vaccine (Live) Single dose vial | Sanofi Pasteur S A, France | R3L025V | 26.09.2018 | Aug 2021 | 30/2019/LR | 22.07.2019 | 2,300 |
| 6 | Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus influenzae Type b conjugate Vaccine Adsorbed 10 dose vial | Biological E Ltd., India | 220101519A | Mar 2019 | Aug 2021 | 31/2019/LR | 16.08.2019 | 50,000 |
| 7 | Adsorbed tetanus vaccine B.P.Single dose vial | Serum Institute of India Pvt.Ltd., India |
2598A005G 2599I002E 2599I004A |
Dec 2018 Jan 2019 Feb 2019 |
Nov 2021 Dec 2021 Jan 2022 |
32/2019/LR | 10.09.2019 |
94,950 109,200 95,850 |
| 8 |
Rabies Vaccine for Human Use (Vero Cell), Freeze-dried - SPEEDA ID administration 5 dose vial (IM administration single dose vial) |
Liaoning Cheng Da Biotechnology Co., Ltd., China. | 201812379 | Dec 2018 | Nov 2021 | 33/2019/LR | 03.09.2019 | 59,560 |
| 9 | Adsorbed tetanus vaccine B.P.10 dose vial | Biological E Ltd., India | 220801218C | May 2018 | Apr 2021 | 34/2019/LR | 12.09.2019 | 20,000 |
| 10 | Measles, Mumps and Rubella Vaccine 10 dose vial | Serum Institute of India Pvt.Ltd., India | 0168N023 | May 2019 | Oct 2021 | 35/2019/LR | 12.09.2019 | 40,000 |
| 11 | Diphtheria, Tetanus and Pertussis Vaccine Adsorbed 10 dose vial | Serum Institute of India Pvt.Ltd., India | 2829X003A | Apr 2019 | Mar 2021 | 36/2019/LR | 20.09.20196 | 15,000 |
| 12 | Human Papillomavirus Quadrivalent Vaccine - Gardasil Single dose vial | Merck Sharp & Dohme B. V., USA |
S019955 | 02.12.2018 | 02.12.2021 | 37/2019/LR | 27.09.2019 | 50,000 |
| 13 | Japanese Encephalitis Vaccine, Live 5 dose vial | Chengdu Institute of Biological Products Co. Ltd., China | 201903C019-2 | 09.03.2019 | 08.03.2021 | 38/2019/LR | 27.09.2019 | 40,000 |
| 14 | Bivalent Oral Poliomyelitis Vaccine 20 dose vial | Sanofi Pasteur, France | R3M47 | 06.11.2018 | Oct 2020 | 39/2019/LR | 01.10.2019 | 40,000 |
| 15 | Diphtheria and Tetanus Vaccine Adsorbed for adult and adolescents 10 dose vial | Serum Institute of India Pvt.Ltd., India | 2339L015G | May 2019 | Apr 2022 | 40/2019/LR | 14.10.2019 | 10,000 |
| 16 | Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus Influenzae type b conjugate Vaccine Adsorbed 10 dose vial | Biological E Ltd., India | 220106819A | Jun 2019 | Nov 2021 | 41/2019/LR | 08.11.2019 | 50,000 |
| 17 | Rabies Vaccine for Human Use (Vero Cell), Freeze-dried - SPEEDA ID administration 5 dose vial (IM administration single dose vial) | Liaoning Cheng Da Biotechnology Co., Ltd., China. | 201901032 | Jan 2019 | Dec 2021 | 42/2019/LR | 23.10.2019 | 60,000 |
| 18 | Rabies antiserum, Equine origin - Equirab 1000 IU/5 mL | Bharat Serums & Vaccines Ltd., India |
A06819009 | Aug 2019 | Jul 2021 | 43/2019/LR | 11.11.2019 | 20,000 |
| 19 | Human Papillomavirus Quadrivalent Vaccine - Gardasil Single dose vial | Merck Sharp & Dohme B. V., USA | S022939 | 05.12.2018 | 05.12.2021 | 45/2019/LR | 15.11.2019 | 175,000 |
| 20 | Yellow Fever Vaccine (Live)Single dose vial | Sanofi Pasteur S A, France | R3L27 | 08.10.2018 | Sep 2021 | 46/2019/LR | 20.12.2019 | 2,000 |
| 21 | Rabies Vaccine for Human Use (Vero Cell), Freeze-dried - SPEEDA ID administration 5 dose vial (IM administration single dose vial) | Liaoning Cheng Da Biotechnology Co., Ltd., China. |
201812379 201902062 |
Dec 2018 Feb 2019 |
Nov 2021 Jan 2022 |
47/2019/LR | 09.12.2019 | 415 59, 585 |
| 22 | Pneumococcal Vaccine, polyvalent (Pneumovax*23)Single dose vial | Merck Sharp & Dohme Corp,U.S.A. | S029118 | 16.04.2019 | 16.04.2021 | 48/2019/LR | 12.12.2019 | 1,200 |
| 23 | Bivalent Oral Poliomyelitis Vaccine 20 dose vial | Sanofi Pasteur, France | T3D50 | 29.04.2019 | March 2021 | 49/2019/LR | 27.12.2019 | 40,000 |
| 24 | Adsorbed Tetanus Vaccine B. P.10 dose vial | Biological E Ltd., India | 220800619C | June 2019 | May 2022 | 50/2019/LR | 27.12.2019 | 20,000 |
|
No. of vaccine/serum lots released = 30 No. of vaccine/serum lots failed to pass lot release = 0 No. of vaccine/serum lots tested following a break in the cold chain, adverse effects following immunization or vaccine failure = 0 |
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