TECHNOLOGY MISSION ON VACCINATION AND IMMUNIZATION OF VULNERABLE POPULATION, PARTICULARLY CHILDREN

Item

Title
TECHNOLOGY MISSION ON VACCINATION
AND IMMUNIZATION OF VULNERABLE
POPULATION, PARTICULARLY CHILDREN
extracted text
TECHNOLOGY MISSION ON VACCINATION

AND IMMUNIZATION OF VULNERABLE

POPULATION, PARTICULARLY CHILDREN

WTfur qg crfran ^mr tfmw
110011
GOVERNMENT OF INDIA
MINISTRY OF HEALTH & FAMILY WELFARE

P. K. UMASHANKAR
Special Secretary

NEW DELHI-110011

FOREWORD

The Universal Immunization Programme, an effective intervention to prevent mortality and
morbidity of children and mortality of pregnant women, was launched on the 19th November, 1985 as
a "Living Hemorial to the memory of our late Prime Minister, Smt. Indira Gandhi".
The Programme
made a modest beginning by covering 30 districts in the country and catchment areas of 50 Medical
Colleges.
The Programme is being extended in phases and, at present, we are covering 182
districts and catchment areas of all the 108 Medical Colleges.
We hope to cover the entire
country by 1990. Having realised the tremendous impact this Programme can have on the health
status of the pregnant women and children of this country, the Government decided to have a
"Technology Mission on Vaccination and Immunization of Vulnerable Population specially children."
Broadly, the objectives of the Mission are to reduce morbidity and mortality of children
due to the six vaccine-preventable diseases, reduce mortality of pregnant women due to Tetanus and
to achieve self-sufficiency in vaccine production.
Under the umbrella of the Mission, all aspects
connected with the delivery of services, research and development on improved and new vaccines,
are also intended to be covered.

The Mission has been divided into two parts viz., Part-I, dealing with implementation of
the Programme and, the Part-II, dealing with the research and development of vaccines.
The first
part is being implemented by the Ministry of Health and Family Welfare is charged with the nodal
responsibility for this Mission.

This booklet on the "Technology Mission on Vaccination and Immunization of Vulnerable
Population specially children" is intended to give brief information on the components of the
Mission and this will form the basis for detailed write-ups on each component, later.

New Delhi
Dated: 1st September,

1987

Special Secretary

CONTENTS

PAGE
TO

FROM

1.

MINISTRY OF HEALTH 8 FAMILY WELFARE

1



2.

DEPARTMENT OF BIO-TECHNOLOGY

41

---- 61

40

TECHNOLOGY MISSION ON VACCINATION E IMMUNIZATION OF
VULNERABLE POPULATION, PARTICULARLY CHILDREN

NODAL AGENCY

:

MINISTRY OF HEALTH 6 FAMILY WELFARE

MINISTRY OF HEALTH g FAMILY WELFARE
SUB-MISSION-I

ADMINISTRATION OF VACCINES, MONITORING AND EVALUATION

SUB-MISSION-II

STORAGE AND DISTRIBUTION OF VACCINES

DEPARTMENT OF BIOTECHNOLOGY
SUB-MISSION-I

VACCINE PRODUCTION

SUB-MISSION-II

VACCINE RESEARCH AND DEVELOPMENT

OUTLINE

OBJECTIVE
COVERAGE

BASIC INFORMATION
STRATEGY
MANAGEMENT STRUCTURE

TARGETS

METHODOLOGY
SUBMISSIONS-ACTION CALENDER
ACCOMPLISHMENT

RESOURCES

MISSION OBJECTIVES

REDUCE MORBIDITY AND MORTALITY DUE TO DIPHTHERIA, PERTUSSISS, TETANUS,
POLIOMYELITIS, TUBERCULOSIS, MEASLES AND TYPHOID AMONG CHILDREN

ACHIEVE SELF SUFFICIENCY IN VACCINE PRODUCTION

COVERAGE

100% OF PREGNANT WOMEN WITH TETANUS TOXOIDE BY 1990
85% OF INFANTS WITH DPT, POLIO, MEASLES, BCG AND TYPHOID BY 1990.

BASIC INFORMATION IMR IN INDIA

150-

*-,
70
i/ An------- 1------ 1------- j------- 1-------,—j------- 1------ 1------- 1------ 1------- 1------- j-------]------ 1

75 76 77 78 79 80 81 82 83 84 85 86

87 88 89 90

INTERVENTIONS TO REDUCE IMR


ANTENATAL CARE

- PERTINATAL CARE

*

IMMUNIZATION

*

FAMILY PLANNING + HIGHER AGE AT FIRST PREGNANCY
SPACING OF CHILDREN
SMALL FAMILY NORM

*

BREAST FEEDING AND INFANT NUTRITION

*

DRINKING WATER AND BETTER SANITATION



CONTROL OF DIARRHOEA AND ORT

*

IMPROVED RURAL HEALTH CARE



HEALTH EDUCATION AND FUNCTIONAL LITERACY

3

DEMOGRAPHIC ESTIMATES 1985

POPULATION
BIRTH RATE

7488 LAKHS

*

DEATH RATE
IMR.

11.7 PER THOUSAND
95 PER THOUSAND LIVE BIRTHS

*

NUMBER OF PREGNANT WOMEN
NUMBER OF INFANTS
ESTIMATED NUMBER OF INFANT
DEATHS IN ONE YEAR

258 LAKHS
245 LAKHS

*

*

*
*

32.7 PER 1000

22 LAKHS

INCIDENCE OF TARGET DISEASES - YEAR 1984

-

29718

*

NEONATAL TETANUS (TETANUS)
POLIO

*

MEASLES

-

190881

*

PERTUSSIS

-

189287

*

TUBERCULOSIS

-

987013

*

DIPHTHERIA

13111

*

TYPHOID



*

18040

306639

SOURCE
4

-

CBHI (REPORTED)

VACCINE PRODUCTION AND REQUIREMENT

( IN LAKHS )
VACCINE

PRODUCTION

REQUIREMENT

PUBLIC SECTOR

PRIVATE SECTOR (ANNL)

1987-88

1988-89

1989-90

1987-88 1988-89

D.P.T.

360

410

450

600

600

800

861

1046

1104

100

POLIO

-

-

10

-

-

-

861

1040

1104

100

BCG

600

600

600

-

-

-

215

261

276

25

T.T.

420

450

480

1000

1000

1200

738.40

1150

1171

100

D.T.

260

260

260

200

200

400

375

379

383

33

T.A.

74

74

74

-

-

-

376

379

383

33

220

313

331



MEASLES

UNICEF

ASSISTANCE

1989-90

1987-88 1988-89 1989-90 BUFFER

OPV IS PRODUCED IN HBPCL, BOMBAY FROM IMPORTED BULK CONCENTRATE
WASTAGE FACTOR - 25% FOR DPT, POLIO, TT, DT, TA AND BCG
- 50% FOR MEASLES
PRIVATE SECTOR MANUFACTURER IS ONLY SERUM INSTITUTE OF INDIA LTD,
PUNE.
THE OTHER PRIVATE MANUFACTURER, BIOLOGICAL E. WILL BE PRODUCING
DPT FROM 1987.

5

FACTORS AFFECTING IMMUNIZATION

1.

HUGE SIZE OF THE COUNTRY

2.

SIZE OF THE POPULATION

3.

POLITICAL WILL

4.
5.

POOR SOCIO ECONOMIC CONDITIONS
LOW LITERACY

6.

DIVERSE CLIMATE

7.

LACK OF ADEQUATE RESOURCES

8.

QUALITY OF VACCINES

PROBLEM

MAJOR STATES
UTTAR PRADESH

RAJASTHAN
MADHYA PRADESH
BIHAR

ORISSA
MINOR STATES
ARUNACHAL PRADESH

MIZORAM
NAGALAND

6

SIKKIM

AREAS

-

LOW COVERAGE
HIGH DROPOUT

STRATEGY

AREA SPECIFIC APPROACH - DISTRICT WISE EXPANSION

DISTRICTS

ACHIEVE 100% COVERAGE FOR PREGNANT WOMEN WITH T.T. VACCINE AND 85% COVERAGE FOR
INFANTS WITH DPT, BCG, POLIO, MEASLES AND TYPHOID VACCINE IN THE DISTRICT WHICH
IS TAKEN UP UNDER UNIVERSAL IMMUNIZATION PROGRAMME IN THAT PARTICULAR YEAR

SR.
NO.

YEAR

COVERAGE
OF DISTT.

1
2
3
4
5

1985-86
1986-87
1987-88
1988-89
1989-90

30
92
182
302
435 +

7

TARGETS
30

28
262422-

NO. OF PREG. WOMEN (In Millions)
NO. OF INFANTS (In Millions)

2018-

14-________ •—_______
BCG
1210-

8■

—-------■------ -""""^rT /

I

82-83

84-85

81-82

u

'
1
l

83-84

BCG WAS BEING ADMINISTERED
TO CHILDREN ABOVE ONE YEAR
PRIOR TO 1984-1985.

85-86

--- j------------- I------------- 1------------- 1---86-P.7
87-88
88-89
89-90

YEAR

------------------ >

MANAGEMENT STRUCTURE

9

ORG. STRUCTURE - MISSION DIRECTORATE (MINISTRY OF H. & F.W.)

10

ORGANISATIONAL

COMMUNITY HZ^LTH CxlL
<7/1. (First Fioor. St. fcteiks Road,

Banaalore - f G' 001.

STRUCTURE OF FIELD ORGANISATION (STATE)

3-5 Crores Pop.

20-30 Districts
20-30 Lacs Pop.
60-75 PHC

30,000 Pop.
6-7 Sub-Centres
5,000 Pop.

12

OPERATIONAL CONSTRAINTS

1.

INSUFFICIENT MOTIVATION

2.

INADEQUATE HEALTH INFRASTRUCTURE

3.

POOR LOGISTIC SUPPORT

4.

DEFICIENCY IN TRAINING

5.

WEAK SUPERVISION AND MONITORING

6.

IRREGULAR FLOW OF FUNDS

7.

CLASHING PRIORITY OF VARIOUS PROGRAMMES

8.

INACCESSIBILITY

13

METHODOLOGY



ENSURE SUPPLY OF FULL REQUIREMENT OF VACCINE

*

ENSURE SUPPLY OF REQUIRED EQUIPMENT i.e. NEEDLES, SYRINGES, STERILIZING EQUIPMENT

*

ENSURE PROPER TRANSPORTATION AND STORAGE OF VACCINE AT AMBIENT TEMPERATURES

*

STRENGTHEN INFRASTRUCTURE



TRAINING STAFF

*

MONITORING OF THE QUALITY OF VACCINATION

*

ENCOURAGE INDIGENISATION OF EQUIPMENT

*

PRODUCTION OF REQUIRED VACCINES



CONCURRENT EVALUATION/INDEPENDENT EVALUATION

*

INVOLVE VOLUNTARY AGENCIES IN ENUMERATION AND ACTUAL VACCINATION



COMMUNITY MOBILIZATION

*

DEVELOP EFFECTIVE I.E.C. ACTIVITY



RESEARCH/DEVELOPMENT FOR IMPROVED VACCINES

14

SUBMISSION-1

ADMINISTRATION OF VACCINES, MONITORING AND EVALUATION
1.

PLANNING IMMUNIZATION

2.

IMMUNIZATION IN THE FIELD

3.

TRAINING

4.

MONITORING

5.

EVALUATION

6.

SURVEILLANCE

7.

COMMUNITY PARTICIPATION

15

1.

16

PLANNING IMMUNIZATION

Selection of districts to be taken
up under UIP for the years 1987-88,
1988-8'j, 1989-90

November, 1986/
May, 1987/
November, 1987

Estimation of targets for Infants
and Pregnant Women, district-wise
for 1987-88, 1988-89 and 1989-90

March, 1987/
June, 1987
December, 1987

Identify districts for special
consideration depending upon the
constraints for 1987-88, 1988-89
and 1989-90

May, 1987/
August, 1987/
June, 1988

IMMUNIZATION IN THE FIELD

17

3.

(i)

MONITORING

MONITORING OF PERFORMANCE IN DIP DISTRICTS
EVERY MONTH

(ii) PERFORMANCE FOR IMMUNIZATION (EPI)
(iii) FIELD VISITS - TECHNICAL/ADMINISTRATIVE OFFICERS

TRAINING PROGRAMME DURING VII-PLAN (1985-1990)

Training during *
1985-86
1986-87
1.

M.O's of PHC’s

1,988

21,666

2.

M P W’s

25,780

303,000

3.

Others
(Dias V.H. Guide
Anganwadi Worker etc.)

20,051

*


18

Total to be Trained during
1985-1990

Figures Provisional

Other Workers are given 2 days
orientation training course.
No. of workers proposed to be
given this course has not been
fixed. States have been given
the discretion.

4.

(i)
(ii)

(iii)

(iv)

TRAINING SCHEDULE

Training to District Health Officer
for 1987-88 UIP Districts

April, 1987

National Planning Management
Course of EPI

April /November, 1987

National Refrigerator Repair
Technical Course

May/October, 1987

Training to District Health Officer
for 1988-89 UIP District

February/March, 1988

19

V
1

EVALUATION >

INTERNAL



I.

CONCURRENT EVALUATION

I

I'.

EVALUATION BY INDEPENDENT BODY

[ .

CONCURRENT EVALUATION

j

*

IDENTIFY THE INSTITUTE/BODY WHICH WILL TAKE UP THIS EVALUATION

j

*

FORMATION OF CORE GROUP FOR1 EVALUATION1

*

SELECTION OF DISTRICT

*

DETERMINATION OF SAMPLE

,

DISTRIBUTION OF PROFORMA AND COLLECTION OF INFORMATION, COMPILATION AND TABULATION



ANALYSIS


i

i

'

.

.

SURVEILLANCE

NO

21

6.

COMMUNITY PARTICIPATION

Increased community participation By Method and Group based approaches (requires consideration
at both levels, community and individual)
(i)

Method adopted:
Mass Media

Inter-personal efforts
Inter-personal communication

22

(ii)

Group based approach:

(1)

Health Workers and ICDS workers

(2)

Political and Social Leaders

(3)

Primary School Teachers and personnel of other Government Welfare Departments

(4)

Medical Students and Medical professionals

(5)

Organised and Co-operative Sectors

SUBMISSION - li

STORAGE AND DISTRIBUTION OF VACCINES

1.

PROCUREMENT OF VACCINES

2.

SUPPLY OF VACCINES

3.

STRENGTHENING OF COLD CHAIN

4.

PROCUREMENT AND DISTRIBUTION OF COLD CHAIN EQUIPMENTS

5.

MONITORING SUPPLY OF VACCINES COLD CHAIN EQUIPMENTS

6.

MONITORING OF COLD CHAIN

23

1.

SUPPLY OF VACCINES

VACCINES

(i)

Monthly review of the Vaccines supply

Every Month

(ii)

Procurement of Vaccines from Private
Sector for 1987-88

April / July /October /
December, 1987

(iii) Review supply of Polio Vaccine from
Public/Private Sectors for 1987-88

April/July /October /
December, 1987/February, 1988

(iv) Assessment of requirement of
Vaccines for 1987-88

September, 1987

Statewise allocation of Vaccines
for 1988-89

January, 1988

(vi) Procurement of Vaccines from Private
Sector for 1988-89

January, 1988

(v)

.24

2,

STRENGTHENINGOF COLD CHAIN

(1)

Assess requirement of UXC’s

February, 1987

(2)

Assess requirement for icelined
refrigerators for 1987-88/1988-89 and
1989-90

January, 1987/
May, 1987/
December, 1987

(3)

Assess requirement of cold boxes,
vaccine carriers, ice packs for
88/1988-89
1987and 1989-90

January, 1987/
May, 1987/
December, 1987

(4)

Assess requirement of refrigerated
vans and Mopeds for Institutes/
States for 1987-88/1988-89 and
1989-90

January, 1987/
May, 1987/
December, 1987

25

3.

Supply of ILRs, Vehicles, Health Education
material etc. to districts under UIP for
1987-88

April/June, 1987

Supply of ILRs, Vehicles, Health Education
material etc. to districts under UIP for
89
1988-

November/December , 1987

Supply of ILRs, Vehicle, Health Education
material etc. to districts under UIP for
90
1989-

May/July, 1988

4.

UNICEF Assistance-requirement of 1988-89

May; 1987

5.

UNICEF Assistance-requirement of 1989-90

November, 1987

6.

UNICEF Assistance-Supply of Equipment of
1988-89

November/December, 1987

UNICEF Assistance-Supply of equipment
of 1989-90

May/July, 1988

1.

2.

3.

7.

26

PROCUREMENT, DISTRIBUTION OF EQUIPMENT

MONITORING SUPPLY OF VACCINES, EQUIPMENT INCLUDING COLD CHAIN

1.

Despatch of Equipment from M.S.D., Bombay,
Madras and Calcutta

Every Month

Despatch of equipment directly as UNICEF
assistance to districts

Every Month

3.

Arrival report of equipment from districts

One time report on receipt

4.

Report on installation of icelined refri­
gerators districtwise

As and when installed

Monthly return from districts regarding
working condition of refrigerators, ice­
liners, Walk-in-Coolers

Every Month

2.

5.

6.

Collection of information and computerising
inventory control.

27

MONITORING OF COLD CHAIN - FOR VACCINES MANUFACTURED IN •• ‘
PUBLIC SECTOR UNDERTAKINGS IN INDIA

*

SYSTEM FOR RECORDING TEMPERATURE AT VARIOUS POINTS OF TIME IN TRANSIT FROM
THE MANUFACTURER TO STATE HEADQUARTERS


4 .

*





1 '

*

SYSTEM FOR MONITORING COLD CHAIN TO BE DEVISED AT THE STATE LEVEL

*

GOVERNMENT OF INDIA WILL MONITOR COLD CHAIN UPTO STATE LEVEL

*

STATE GOVERNMENT WILL MONITOR MAINTENANCE OF PROPER COLD CHAIN FROM THE
STATE HEADQUARTERS TO THE PHC LEVEL

*

- VACCINE PROCURED FROM PRIVATE SECTOR THROUGH DGSfiD -

*

THE SUPPLIER WILL GIVE INFORMATION IN PRESCRIBED PROFORMA FOR TEMPERATURES
AT VARIOUS POINTS OF TIME DURING TRANSIT FROM THE DISTRIBUTION POINT TO
STATE HEADQUARTERS

*

BEYOND THE STATE HEADQUARTERS THE COLD CHAIN MONITORING WILL BE DONE BY
STATE GOVERNMENT

, .

28

' •



JI,.

■ •







RESOURCES

1.

FINANCIAL OUTLAY

YEARWISE ESTIMATES EXPENDITURE
(RUPEES IN MILLION)

Non-Recurring

Recurring

142

1989-90
148

Total
535

390

486

1603

1985-86
55

1986-87
89

1987-88

1988-89

101

185

238

304

Towards vaccine
production

$$

262
240

327

405

532

634

2400

(Say Rs. 240.00 Crores)

29

2.

INFRASTRUCTURE

INFRASTRUCTURE FOR DELIVERY OF SERVICES

FORMATION

30

OPERATIONAL

(1986)

TO BE SET UP BY 1990

TOTAL

C.H.C.

767

1941

2708

P.H.C.

12314

9352

21666

SUB-CENTRE

89819

40181

130000

POST PARTUM CENTRE

1118

636

1754

MEDICAL COLLEGES

106

-

106

HOSPITAL-GOVERNMENT

3575

-

3575

OTHER

3459

-

3459

DISPENSARIES

21226

-

21226

3.

HUMAN RESOURCES

STAFF POSITION : KEY HEALTH WORKERS

STAFF

REQUIRED (By 1990)

APPOINTED (till 1986)

Multipurpose Worker (Female)

130,000

100,558

Multipurpose Worker (Male)

130,000

84,598

Female Health Assistant

21,666

16,894

Male Health Assistant

21.666

25,208

Dais

580,000

545,214

Village Health Guide

500,000

390,188

Anganwadi Workers

124,915

31

4.

UNIpEF COOPERATION
*

Incremental Capital and Operating Costs for UIP District Programme

Figures in 'OOO1
. (In US Dollars)
Capital

Year

1985

30 X 216

=

6,480

1986

60 X 216

=

12,960

Operating Cost

. Total . ..
6,480

30 x 26

=

780

1987

90 X 216

=

19,440

90 x 26

=

2.Q40

13,740
. ■ 11 . ■ ;
21,780

1988

120 X 216

=

25,920

180 x 26

=

4,680

30,600

1989

120 X 216

=

25,920

300 x 26

=

7,800

33,720

GRAND
TOTAL

420 X 216

=

90,720

600 x 26

=

15,600

106,320

..

32

*The Governments of Canada and Sweden have made available
supplementary funds for UIP through UNICEF as follows:
CIDA
USS 26 million
S1DA
USS 33 million
Moreover, Rotary International has agreed to supply
Oral Polio Vaccine with a value of USS 19 million, but
this is not included in this Table 4.

ACCOMPLISHMENTS

YEARWISE TARGETS AND ACHIEVEMENTS DURING

1981-82 TO 1989-90

(Figures in Millions)
Year

T.T. (PREG. WOMEN)
Achv.
1arget
% Achv.
Of Tg.

Target

1981-82

7.96

7.11

89.5

15.97

9.23

1982-83

9.00

7.64

84.9

13.97

1983-84

11.50

8.19

71.3

1984-85

13.0

9.27

1985-86

12.85

15.20
1986-87
(upto Jan. 87)

INFANTS
Achv. % Achv.
of Tg.

Target

POLIO
Achv.

57.9

2.40

2.93

123.8

10.34

74.00

5.24

4.55

87.00

15.0

11.13

76.70

7.30

7.90

105.9

71.3

14.5

12.34

85.10

12.00

9.76

81.33

9.31

72.5

14.04

13.34

95.0

14.04

11.98

85.3

7.99

74.2

15.30

3.41

76.6

15.30

7.96

71.8

1987-88

18.6

16.9

1988-89

21.9

17.7

1989-90

23.9

17.0

%Achv.
of Tg.

33

YEARWISE TARGETS AMD ACHIEVEMENT DURING 1981-82 TO 1986-87

(Figures in Million)
Tg.

D.T.
Achv.

% Achv.

T.T.(SC)
TYPHOID
%
Achv.
Achv.
TgT£^_ Achv. % Achv.

Year

Tg.

BCG
Achv.

1981-82

15.0

13.58

90.53

12.57

10.81

86.10

10.0

2.63

26.6

3.5

1.81

51.7

1982-83

15.0

13.93

92.87

12.50

10.25

32.0

10.0

5.02

50.8

5.0

3.11

62.2

1983-84

15.0

13.96

93.07

13.0

10.53

81.0

10.0

6.17

61.7

6.5

4.42

63.0

1984-85

14.3

12.32

84.97

13.0

11.33

37.2

11.0

7.27

66.1

8.0

6.12

76.5

1985-86

14.04

12.89

91.9

11.19

11.10

99.2

11.9

6.99

62.5

8.84 6.70

75.8

1986-87

15.30

' 8.80

80.3

% Achv.

(upto Jan., 87)

Contd

34

Contd

Yearwise Targets and Achievement during 1986-87 to 1989-90

Year

___________________ MEASLES
Tg.
Achv.

1986-87
(upto Jan., 87)

5.70

1987-88

10.0

1988-89

14.2

1989-90

18.3

1.11

________________
% Achv. of Tg.

30.2

. 35

TESTING AND QUALITY CONTROL OF VACCINES

IDENTIFY INSTITUTIONS/MEDICAL COLLEGES/LABORATORIES WHICH
CAN TAKE UP TESTING OF FIELD SAMPLES

May, 1987

ASSESS THE ADDITIONAL REQUIREMENT OF THESE CENTRES FOR MAKING
SUITABLE TO TAKE UP TESTING OF VACCINES

July, 1987

IDENTIFY THE STATES TO BE ASSOCIATED WITH THE SPECIFIC
IDENTIFIED INSTITUTE

August, 1987

(iv) DEVELOP REPORTING SYSTEMS OF TESTING OF FIELD SAMPLES IN
THESE IDENTIFIED INSTITUTES

July, 1987

(i)
(ii)

(ii)

(v)

36

USE COMPUTERISED M.I.S. FOR ANALYSIS OF TESTING RESULTS

September, 1987

INVOLVEMENT OF VOLUNTARY AGENCIES
I

IDENTIFY VOLUNTARY AGENCIES IN EACH rilSTRicT
TO SELECT SUCH AGENCIES WHICH CAN HELP IN DEMAND GENERATION, ENUMERATION
AND ACTUAL VACCINATION
IDENTIFY MAJOR VOLUNTARY AGENCIES SPARED OVER ACROSS THE COUNTRY/STATES
NUMBER OF DISTRICTS

IDENTIFY SUITABLE AGENCIES TO WORK IN URBAN SLUMS

PROVIDE FINANCIAL ASSISTANCE WHEREVER UNAVOIDABLE

37'

MANAGEMENT INFORMATION SYSTEM

COMPUTER TO BE USED FOR COMPILATION OF DATA AND INVENTORY CONTROL

MONITORING OF IMMUNIZATION
SURVEILLANCE
LOGISTICS OF EQUIPMENT INCLUDING COLD CHAIN

FINANCIAL CONTROL

SUPPLY OF VACCINES
EVALUATION REPORTS

Computer is needed at the State Headquarters/District Headquarters.

38

TECHNOLOGY MISSION ON
VACCINATION AND IMMUNIZATION OF

VULNERABLE SECTIONS OF POPULATION

ESPECIALLY CHILDREN

SUB-MISSIONS

I.

VACCINES PRODUCTION

II.

R&D FOR NEW VACCINES

DEPARTMENT OF BIOTECHNOLOGY
MINISTRY OF SCIENCE AND TECHNOLOGY

39

SUB-MISSION - I
PRODUCTION OF VACCINES

41

OBJECTIVES

Modernization and capacity expansion in major public sector units to meet the EPI demands
for DPT, DT, TT, BCG and Typhoid vaccines.
To establish indigenous production capacities before 1990 for Measles, Polio and tissue
culture Rabies vaccine employing advanced technologies.

To undertake detailed evaluations including field trials of R-DNA hepatitis-B vaccine and
new pertussis vaccine and to set up indigenous production capacities for those vaccines
by 1990 or soon thereafter.

43

SOME DESIRABLE CHARACTERISTICS OF VACCINES CONSIDERED
IN THE CHOICE OF VACCINES/PROCESS TECHNOLOGIES

High efficacy

(Minimum number of doses to ensure long lasting immunity, better sero-conversion
etc.)
safety and minimum side effects.
Long shelf life.
Heat stability.

Distribution through common cold chain.

Ease of application.
Adequate availability.
Ability to combine with other vaccines as vaccine "Cock tails" and

Low cost.

44

DROP-OUT AND VACCINATION COVERAGE

DOSES/
VISITS

DROP-OUT
RATE

3

25%

100

56.25

3

20%

100

64.00

3

10%

100

81.00

3

’7.5%

100

85.50

4

5%

100

85.70

NUMBER OF RECIPIENTS
FIRST VISIT LAST VISIT

MINIMUM VACCINATION VISITS DURING FIRST YEAR - 4
Note:

The drop out rate in India is about 25%. Vaccines requiring multiple
doses calls for multiple visits/recalls, which results in a large cumu­
lative drop out and low coverage. Vaccines requiring fewer doses
(ideally single shots) would greatly help improve the coverage.

45

SOME SALIENT FEATURES OF VACCINE PRODUCTION STRATEGY


1





' '

»



1

Number of doses manufactured and schedule of production and supply to match
the estimated annual requirements of the EPI»

Quality of the products to meet strictly the standards set by the World Health
Organisation.
Quality of the products to be certified by a independent National Quality Control
and Standardization Laboratory.
The cost of indigenously producted vaccine to be internationally competitive and to
enhance the cost-effectiveness of the national programme.

The production units should have strong in house R

46

D component.

TECHNOLOGIES FOR PRODUCTION OF VACCINES

MEASLES VACCINE

I.
II.

CHICK EMBRYO FIBROBLAST TECHNOLOGY
HUMAN DIPLOID CELL BASED CELL CULTURES

ORAL POLIO VACCINE
PRIMARY MONKEY KIDNEY CELL CUTURES

KILLED POLIO VACCINE
RABIES VACCINE
CONTINUOUS VERO CELL MICROCARRIER FERMENTATION
TECHNOLOGY

HEPATITIS-B VACCINE
R- DNA BASED YEAST/CHO CELL TECHNOLOGY

NEW PERTUSSIS VACCINE

MONO COMPONENT - TOXOID VACCINE (SUB UNIT VACCINE)
OR TWO COMPONENT - TOXOID AND FILAMENTOUS
HAEMAGLUTININ VACCINE (SUB UNIT VACCINE)

48

PRODUCTION OF VACCINE - INDUSTRIAL PROJECT

STAGE - I
-

Live attenuated measles vaccine

25 Million doses

-

Oral Polio vaccine

100 Million doses

Killed polio vaccine

50 Million doses

Tissue culture rabies vaccine

5 Million doses

-

STAGE - II


R-DNA Hepatitis-B Vaccine

2 Million doses

-

Acellular pertussis vaccine

50-80 Million doses

EXPECTED DATES OF BULK INDIGENOUS PRODUCTION OF VACCINES

Measles vaccine

April 1989

Polio vaccine

January 1990

Rabies vaccine

January 1990

Hepatitis-B vaccine

December 1990 or soon thereafter.

New Pertussis vaccine

December 1990 or soon thereafter.

CAPACITY EXPANSION IN EXISTING UNITS

VACCINE

DPT

TETANUS
TOXOID

BCG

INSTITUTE

PRODUCTION
85-86

PLANNED
CAPACITY
89-90

%
EXPANSION

CRI, KASAULI
PI, COONOOR
HPCL, BOMBAY

13
9
6

20
15
10

54
67
67

TOTAL

28

45

61

CRI, KASAULI
PI, COONOOR
HBPCL, BOMBAY

22
6
8

22
10
14


67
75

TOTAL

36

46

21

BCG VACCINE
LABORATORY
MADRAS

16

22

27

49

PROGRESS MADE

Two technical expert committees studied the vaccine requirements, state of the
art of technologies for vaccine production and recommended urgent steps to sqt
up indigenous RSD cum production facilities through transfer of most advanced
and appropriate technologies for:

-

Hyper attenuated measles vaccine
Injectible polio vaccine (Vero)
Inactivated tissue culture rabies vaccine 5
R-DNA Hepatitis - B vaccine.

An inter-ministerial negotiating committee finalised the technologies and terms and
conditions of transfer of technologies for, measles, rabies and polio vaccines.

Evaluation of technologies for hepatitis-B vaccines, oral polio vaccine and new
pertussis vaccines are in progress.

51

SUB-MISSION - JI

R&D FOR NEW AND IMPROVED VACCINES

53

SELECTED DISEASES FOR VACCINE R£D

56

a)

Urban rabies with special reference to oral vaccine baits for canine rabies
control.

b)

Diarrhoeal diseases : Cholera, Shigellosis, Rotaviral diarrhoea, Salmonellosis.

c)

Typhoid

d)

Hepatitis-B

e)

hepatitis-N ANB

f)

Malaria and

g)

Pneumonia

OBJECTIVES

To set up, promote, undertake and monitor highly competitive R&D activities in
vaccinology with a view to develop new process technologies for new or improved
vaccines and vaccine cock tails such as:

R6Djprototype development and field evaluation of oral vaccines against cholera,
typhoid etc.
Development of stable and environmentally safe vaccine baits for canine rabies
control in India.

Epidemiological and etiological studies as well as vaccine development and
validation against hepatitis NANB and streptococeal pheumonia. 1
R8D and evaluation of new sub unit vaccines such R-DNA based and synthetic
vaccines»

Development of polyvalent vaccines and vaccine 'cock tails'.

55

RABIES - PROJECTS AND INSTITUTIONS IDENTIFIED

Development of mass immunizing agents against canine rabies in India
- urban and rural.

Analytical typing and survey of street virus prevalence in India.
Studies on the substitution of the reactogenic equine hyperimmune
serum with other safer agents (interferon inducers)

Pasteur Institute, Coonoor.
National Institute of Virology, Pune.

58

HEPATITIS: PROJECTS AND INSTITUTIONS IDENTIFIED

Study of the duration of efficacy 6 safety of genetically engineered
yeast vaccine as compared to plasma derived vaccine.
All India Institute of Medical Sciences, New Delhi.
National Institute of Virology, Pune.
Development of new recombinant vaccines for immunization against
viral hepatitis-B, rabies and malaria.

National Institute of Immunology, New Delhi.

Identification and characterisation of virus particle/particles causing
NANB hepatitis-detection of humoral immune responses, and development
of reagents and tests for specific diagnosis of NANB hepatitis.
All India Institute of Medical Sciences, New Delhi.
National Institute of Virology, Pune.

57

PERTUSSIS AND OTHERS

R5D cum production, standardisation and quality control of acellular
pertussis vaccine in India.

Central Research Institute, Kasauli.
Pasteur Institute, Coonoor.



Development of an evaluation unit at AIIMS for vaccines used in
children.
All India Institute of Medical Sciences, New Delhi.

DIARRHOEAL DISEASES (CONTD..)

Development of new vaccines against S. typhi.

All India Institute of Medical Sciences, New Delhi.
Studies on the development of an attenuated cholera vaccine.

Banaras Hindu University, Varanasi.
Studies on development of an effective vaccine against
shigellosis caused by Shigella dysenteriae.

National Institute of Cholera and Enteric Diseases, Calcutta.

DIARRHOEAL DISEASES: PROJECTS AND INSTITUTIONS IDENTIFIED

Study of rota viral infection and development of vaccines against
rota viral diarrhoea.
National Institute of Cholera and Enteric Diseases, Calcutta,
Director General of Health Services, Manipur.

Development of improved cholera vaccine (adhensive factor)
Central Drug Research Institute, Lucknow.

Jawaharlal Nehru University, New Delhi.
Research and Development of diagnostics and vaccine against
diarrhoegenic E .coli.
National Institute of Cholera and Enteric Diseases.

Improved diagnostic facilities for diarrhoeal diseases through
DNA probes.

National Cholera and Enteric Diseases, Calcutta.

Banaras Hindu University, Varanasi.

NOTES

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