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DIRECTORATE GENERAL OF HEALTH SERVICES

Ministry of Health & Family Welfare
Government of India

Institutes

Vaccines and Vaccine Manufacturing Institutes

 1. Background:

Currently, there are 26 diseases, which have effective vaccines available for prevention. These diseases are as under;

     
Anthrax
2. Cervical Cancer(HPV)
3. Chickenpox(varicella)
4. Cholera
5. Diphtheria
6. H. influenza type b
7. Hepatitis A
8. Hepatitis B
9. Influenza (flu)
10. J. Encephalitis
11. Lymes Disease
12. Measles
13. Meningococcal
14. Mumps
15. Pertussis (W.cough)
16. Pneumococcal
17. Poliomyelitis
18. Rabies
19. Rotavirus diarrhoea
20. Rubella(G.Measals)
21. Shingles (H.Zoster)
22. Small pox
23. Tetanus
24. Tuberculosis
25. Typhoid fever
26. Yellow Fever

 Currently, vaccines candidates are recommended for uses for prevention of 21 vaccine preventable disease. Some vaccines used in combination (i.e. pentavalent) under routine immunization programme. Vaccines against five diseases not recommended. These are; Anthrax, Lyme’s Disease, Shingles (Herpes Zoster), Smallpox and Varicella (Chicken pox).

 2. UIP VACCINES

India has a national programme for immunization, popularly known as ‘Universal Immunization Programme (UIP)’. It aims to vaccinate against 11 vaccine preventable diseases of childhood. The vaccines used under UIP and the diseases prevented are as under;

(i) BCG – Tuberculosis

(ii) Pentavalent

(iii) DPT

(iv) TT

(v) Polio drops-Poliomyelitis

(vi) Measles – Measles

(vii) JEV – Japanese Encephalitis

(viii) Rubella vaccine

(ix) Rotavirus

 

3. NON-PROGRAM VACCINES:

WHO Advisory Committee on Immunization has recommended use of other vaccines for prevention of diseases as under;

 

3.1.Vaccines Recommended for All:

  •  Haemophilus Influenzae type b (Hib)
  •  Pneumococcal Conjugate vaccine (PCV)
  •  Rotavirus Vaccine
  • Human Papilloma virus Vaccine (HPV)

Advisory committees have submitted that Hib, Pneumococcal and Rotavirus are widely prevalent and causes lot of morbidity and mortality among children >5 years. Human Papilloma virus infection causes cervical cancer and results in pre-mature morbidity and mortality among younger women.

 

3.2.Vaccines Recommended for High Risk Populations:

  • Typhoid vaccine
  • Hepatitis A vaccine and
  • Cholera vaccine

Typhoid, Hepatitis A, Meningococcal infection and cholera are endemic disease in India and causes significant morbidity and mortality among population groups at risk.

 

3.3.Vaccines with certain characteristics:

  • Mumps vaccine
  •  Rubella Vaccine and
  •  Influenza vaccine

Mumps, Rubella and Influenza vaccines are recommended with certain characteristics of the programme i.e. only for those areas where Immunization coverage is >80%. If the coverage is less than 80%, it has no effect. India has very few States that have reached required coverage level for considering roll out of these vaccines.

 

4. Vaccines covered under International Health Regulation:

  •  Yellow Fever Vaccine (YFV) and
  •  Quadrivalent Meningococcal Meningitis Vaccine (QMMV) 

Vaccination with above mentioned two vaccines of YFV and QMMV is mandatory under International Health Regulations. The average requirement of YFV in India is 1,50,000 doses per annum and that QMMV for vaccination of Hajj Pilgrims in India is about 2,00,000 doses per annum.

 

5. Post Exposure Vaccination:

  •  Rabies vaccine and
  •  Anti-snake venom serum 

Rabies vaccine and Anti-snake venom serum have specific indications of post exposure vaccination i.e. people bitten by Dogs and Snakes. Timely vaccination to people bitten by dogs and snakes, 100% prevent disease/death, otherwise both are 100% fatal. Estimated annual dog bite cases in India are 17.4 Million and estimated requirement of TCARV is 87.00 million doses @ 5 doses per case. The estimated snakebite cases per annum are 250000 and estimated requirement of ASVS will be 45.00 lakh vials @ 18 vials per case.

6. ANTI-SERA

Anti-tetanus toxoid serum (ATTS)

Anti-diphtheria toxoid serum (ADTS)

Anti-rabies serum (ARS)

 Anti-snake venom serum (ASVS)

 Anti-scorpion venom serum (AScVS)

 Anti-gas gangrene serum (AGGS)

Widely used anti-sera are ARS and ASVS. ADTS is used in children and are lifesaving drugs. ATTS, AScVS and AGGS are of limited use.

Estimated requirement of vaccines and annual installed capacity of the vaccines are given in table 1. Institution wise vaccines manufactured are given in table 2.

Table No. 1

Annual Requirement and Installed capacity of different vaccines manufactured by Public and Private Sector Institutions

(Qty in lakh of Doses)

S. No Biologicals Annual requirement of UIP Vaccine in the country Annual Installed capacity per annum
 I  UIP Vaccines    
 1 BCG  600  2000
 2 Pentavalent  880  6160
 3 DPT  70  10043
 4 DT    1050
 5 TT  1100 15862
 6 OPV  1300 34200
 7 IVP  300  
 8 Measles  700 4300
 9 JEV  200 2010
 10 Rotavirus vaccine  100  
 11 MR  ? 2000
 


II Non-UIP Vaccines
 
12
JEV (Imported & Indigenous)
2011.1
13
TCARV
284
14
Typhoid (vi-polysaccharide)
370
15
Typhoid (AKD)
30
16
Hepatitis-B
5360
 
 
 
III
IHR Vaccines
 
12
YFV
0.55
13
QMMV
15
14
Seasonal Influenza vaccine (Imported)
0
 
 
 
IV
Newer Vaccines
 
15
Hib vaccine
40
16
DTwp-HepB
540
17
DTwp-Hib
4500
18
DTwp-HepB-Hib
Qty not defined
19
MMR
Do
 
 
 
V
Anti-Sera Qty in lakh of vials
20
ATS
8.7
21
ADS
2.2
22
ASVS  (Snake)
75.20
23
ASVS (scorpion)
0.95
24
ARS
7.4
25
AGGS
4
26
NHS
0
 
 
 
VI
 Other Diagnostic & Reference Standards
 
27
Diagnostic Reagent
2.75
 

 

Institution-wise Installed capacity of the UIP and Non-UIP vaccines 

 

 
Particulars
UIP - Vaccines      
Non-UIP vaccines
S. No
Name of Institutions
BCG
Penta
DPT
DT
TT
OPV
IPV
Measles
Rubella
HepB
JEV
Hib
YFV
TCARV
Typhoid (vi-poly)
PCV
Cholera
QMMV)
MMR
MR
Quadruple
Tetra valent
Hep A
Seasonal Influenza
1
BCG VL Channai
1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2
PII Coonoor
 
 
1
1
1
 
 
 
 
 
 
 
 
1
 
 
 
 
 
 
 
 
 
 
3
CRI Kasauli
 
 
1
1
1
 
 
 
 
 
1
 
1
 
 
 
 
 
 
 
 
 
 
 
4
HBPCl Mumbai
 
 
1
1
1
1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5
SII Pune
1
1
1
1
1
 
 
1
1
1
 
1
 
1
 
 
 
 
1
1
1
1
1
1
6
Biological E Ltd Hydbad
 
1
1
1
1
 
 
 
 
1
1
 
 
 
 
 
 
 
 
 
 
 
 
 
7
KIPM Chennai
 
 
 
 
1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8
Pasteur Instt.Shilong
 
 
 
 
1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9
SVI Patwandnagar
 
 
 
 
1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10
IPM Hyd'bad
 
 
 
 
1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11
Bio Vaccine Hud'bad
 
 
 
 
1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12
Dano Vaccine Hud;bad
 
 
 
 
1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
13
Panacea Biotech Ltd Dehli
 
1
 
 
 
1
 
 
 
1
 
1
 
 
 
 
 
 
 
 
1
1
1
 
14
Bio-med (P) Ltd. Ghaziabad
 
 
 
 
 
1
 
 
 
 
 
1
 
 
1
 
 
1
 
 
 
 
 
 
15
Zydus Cadilla Ahmedabad
 
 
 
 
 
 
 
 
 
 
 
 
 
1
1
 
 
 
 
 
 
 
 
1
16
Bengal Chem. & Pharm. Kolkotta
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
 
17
Bharat Bio int. Ltd. Hy'bad
 
1
 
 
 
1
 
 
 
1
1
1
 
1
1
 
 
 
 
 
 
 
 
 
18
BS & Vaccine Ltd. Thane
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
19
Cadilla Pharm. Ltd. Ahemdabad
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
20
Shanta Biotech. Pvt. Ltd. Hy'bad
 
1
1
 
1
 
 
 
 
1
1
1
 
 
 
 
1
 
 
 
1
1
 
 
21
Wockordt ltd Mumbai
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
 
22
HBI Udhagamand Guj
 
 
1
 
1
 
 
1
 
1
 
 
 
1
 
 
 
 
 
 
 
 
 
 
23
Chiron Behring Lab Ankaleshwar Guj
 
 
 
 
 
 
 
 
 
 
 
 
 
1
 
 
 
 
 
 
 
 
 
 
24
BIBCOL Bulandshahar
 
 
 
 
 
1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
25
Sanofi Pasteur India Pvt.Ltd Delhi
 
 
 
 
 
 
1
 
 
 
 
 
 
1
 
 
 
 
 
 
 
 
 
 
26
Indian Immuno9logical Limited
 
 
1
 
1
 
 
1
 
 
 
 
 
1
 
 
 
 
 
 
 
 
 
 
 
Total
2
5
8
5
14
5
1
3
1
6
4
5
1
8
3
0
1
1
1
1
3
3
4
2