History of BCG Vaccine Laboratory

8/8/2019 History of BCG Vaccine Laboratory

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HISTORY OF BCG VACCINE LABORATORY

The BCG Vaccine Laboratory, Chennai is a sub-ordinate office of the Directorate General of

Health Services (DGHS) under the Ministry of Health and Family Welfare of the Government of India,

possessing International Accreditation (ISO 9001:2000) issued by B VQI. It was established on 1 st May,

1948. The activities of this Laboratory are:

1. Manufacture of Freeze Dried BCG Vaccine for the control of Childhood Tuberculosis andTuberculous Meningitis in children and supply to Expanded Programme of Immunization (E PI) of the

Government of India and to other needy medical faculties/ Hospitals:

2. Manufacture and supply of Freeze Dried BCG Therapeutic (40mg) for cancer Chemotherapyespecially Carcinoma of Urinary Bladder all over the country.

3. To act as National Quality Control Laboratory for BCG Vaccine.BCG VACCINE

Production of BCG Vaccine: BCG Vaccine is a live freeze-dried vaccine made from an attenuated strain

of Mycobacterium bovis. It is used for the prevention of tuberculosis.

During the year 1948 this Laboratory was producing and supplying liquid BCG Vaccine from DANISH -

1331 BCG Seed Strain. The BCG Seed Strain was initially obtained from Statens Serum Institut (SSI)

Copenhagen, Denmark through World Health Organization (WHO) for production of liquid BCG Vaccine.

This strain is one among the best strains available in the world. Subsequently BCGVL started preparing

its own BCG Seed called Madras Working Seed Lot (MWSL)

Change of technology from liquid form to Freeze Dried form of BCG Vaccine:

The BCGVL started manufacturing Freeze Dried BCG Vaccine with a shelf life of more than 2 years in

the form of 50 doses ampoules along with liquid BCG Vaccine. In view of unique advantages of Freeze

Dried BCG Vaccine over the liquid BCG Vaccine, the BCGVL, switched over completely from liquid BCG

Vaccine to Freeze Dried BCG Vaccine during 1973. Due to the increased wastage during immunizationusing 50 dose BCG Vaccine per ampoule, BCGVL changed its preparation of vaccine from 50 doses per

ampoule to 20 doses per ampoule from the year 1982.

Change of technology from ampoules to vials:

The manufacture of BCG Vaccine in ampoules has to undergo the process of sealing of ampoules. It

was observed that during the process of sealing of ampoules, major wastage of ampoul es occur. It was

also observed that production of BCG Vaccine in vials instead of ampoules would lead to saving in

electricity, man-power and also other consumables. Hence, BCGVL switched over to production of BCG

Vaccine in vials from 2001 onwards for w hich it installed machineries & equipments to the tune of 1.5

crores.

The installed capacity of this laboratory for production of BCG Vaccine till 1998 was 400 lakh (40

million) doses. But the need for BCG Vaccine for Expanded Programme of Immunization o f Ministry of

Health & Family Welfare was 550-600 lakh (55 to 60 million) doses. As a result, the Ministry of Health

and Family Welfare has to import BCG Vaccine of 200 lakh dose/year from other countries through

UNICEF.

To increase the production of BCG Vaccine in order to meet the Countrys Demand for Expanded

Programme of Immunization and to reduce the cost of production, this Laboratory opted to change its

technology of production. It installed new Freeze Driers with vial stoppering facility at the cost of Rs.


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1.5 crores, through Hospital Services Consultancy Corporation, Noida. By purchase of these major

equipments, this laboratory was able to switch over to manufacture of BCG Vaccine in vials from

ampoules, by which loss during sealing of the amp oules has been reduced and in turn the production

quantity has increased. It attained self -sufficiency from the year 2000 onwards and import of vaccine

through UNICEF was also stopped.

PRODUCTION OF BCG VACCINE

Year BCG Vaccine

(in lakh doses)

1997-98 411.78

1998-99 242.27

1999-2000 527.35

2000-01 774.35

2001-02 543.68

2002-03 658.52

2003-04 923.17

2004-05 853.61

2005-06 580.46

2006-07 831.472007-08 599.01

2008-09

Presently from the year 2005 onwards BCG Vaccine is being manufactured in 10 dose vials.

Administration:

For children under one year 0.05 ml. And for others 0.1 ml. of reconstituted vaccine is given

intradermally. Reconstitute only with the diluent supplied by the manufacturer. Special syringes allow

administration of exact dose. A sterile syringe and a sterile needle should be used for each injection.

The skin should not be cleaned with antiseptic. Jet injection do not generally provide a reliable dose of

BCG and should not be used. Special care is needed in opening the vials and reconstituting the

vaccine so that the vaccine is not blown out of the vial. Because of sensitivity to daylight, the vaccine

must be kept in the dark. When withdrawals are made from the vial, the vaccine must be exposed to

the light for a minimum period of time, and never for longer than four hours. If not used immediately

after reconstitution, the vaccine should be kept on ice and at the end of a session (maximum 4 hours)

must be discarded. Skin testing with tuberculin is not g enerally carried out before giving BCG, but when

performed those who are found to be positive reactors need not be immunized.

Immunization:

BCG should be given routinely to all infants at risk of early exposure to the disease. For a maximumprotection, this vaccine should be given as soon after birth as possible. It can be given at a same time

as DPT, DT, TT, measles, polio vaccines (OPV & IPV), Hepatitis -B and Yellow Fever vaccine.

Side effects:

A local reaction is normal after BCG. A small tender red swelling appears at the site of the injection

which gradually changes to a small vesicle and then an ulcer in 2-4 weeks. The reaction usually


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resides within two to five months and in practically al l children leaves a superficial scar 2-10 mm in

diameter. Rarely, nodule may persist and ulcerate. Occasionally enlargement of axillary lymph nodes

may appear in 2-4 months following immunization. Inadvertent subcutaneous injection produced

abscess formation and may lead to ugly retracted scars.

Contra indications:

The vaccine is contra indicated in those with cell -mediated immune deficiency. Keloid and Lupoid

reactions may occur at the site of injection and such children should not be revaccinated.

Human Immuno-deficiency virus injected infants:

HIV infected, non symptomatic infants should be immunized with BCG Vaccine according to standard

schedules. Infants with clinical (symptomatic) AIDS should not receive BCG Vaccine (but should receive

other EPI vaccines).

Storage:

BCG Vaccine should be stored and transported between 0 and 8C. It is even more stable if stored in

temperatures as low as -20C. The diluent should not be frozen but kept cool. Protect the vaccine from

the light.

SUPPLY OF BCG VACCINE:

BCG Vaccine produced in 20/ 10 dose vials is being supplied to Expanded Programme of Immunization

of Government of India, Ministry of Health & Family Welfare. It is also supplied to private medical

practitioners/ Hospitals on prescription.

SUPPLY OF BCG VACCINE (INDIGENOUS & IMPORTED) TO EPI PROGRAMME & PRIVATE PARTIES

Year BCG Vaccine to EPI

(in lakh doses)

BCG Vaccine to

Private Parties

(in ampoules)Indigenous Imported Total

1997-98 302.09 199.07 501.16 38,678

1998-99 315.96 180.47 496.43 41,939

1999-2000 333.57 138.08 471.65 43,627

2000-01 575.41 47.61 623.02 48,301

2001-02 549.72 -- 549.72 47,002

2002-03 585.00 -- 585.00 35,784

2003-04 530.00 -- 530.00 24,355

2004-05 482.00 -- 482.00 19,210

2005-06 637.00 -- 637.00 17,699

2006-07 758.66 -- 758.66 16,518

2007-08 489.50 -- 489.50 12,4442008-09 .

BCG THERAPEUTIC (40 MG.)

From the year 1994 BCGVL started manufacturing BCG Therapeutic Vaccine (40mg). This is also a live,

freeze-dried preparation of Danish 1331 strain of BCG Mycobacterium bovis, meant for therapeutic use

in Carcinoma bladder. Sodium glutamate is used as sta bilizer. No preservatives are added.


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Indications:

It is mainly indicated for adjuvant theraphy in transitional Cell Carcinoma (TCC) of the urinary bladder

after a definitive treatment. In selected cases of TCC it may be used for primary theraphy also.

1. Superficial/ non-invasive ca.bladder (Stage A or TA), tumors with lamina propria invasion (T1)and selected cases of Stage B1 after TUR

2. Recurrent & multiple superficial TCC of bladder.3. Ca.insitu of bladder. It is not indicated for treatment of so litary papillary tumors.

Dosage & Administration:Usual dosage consists of intravesical instillation of 120 mg. BCG (Freeze dried) Therapeutic once a

week for six weeks. Contents of three ampoules (40 mg. each) are suspended in 60 ml. Of

physiological saline and instilled into the urinary bladder through a urethral catheter. The patient

should be instructed to retain the drug in the urinary bladder by not urinating for atleast two hours after

instillation and during this period he should frequently alter his position.

Adverse reactions:

Adverse reactions include dysuria, urinary frequency, hematuria and fever which may require

interruption or discontinuation of therapy.

Contra indications:

1. Active tuberculosis; 2. Immuno deficiency/ Immuno suppress ive therapy; 3. Urinary tract

infections; 4. Trauma to the urinary bladder; 5. A patient with fever needs careful evaluation before

therapy is instituted; 6. Safety of this mode of therapy in pregnant women, nursing mothers and

children has not been evaluated.

Important Note:

Intravesical instillation of BCG may lead to systemic BCG infection in immuno -compromised patients.

This is a life threatening situation and needs prompt treatment with appropriate therapy.

Precaution:

This preparation contains live attenuated mycobacterium (BCG) and should be viewed BIOHAZARDOUS.

All equipments coming in contact with this preparation are to be properly disinfected/ sterilized/

disposed off. Urine voided for 6 hours after instillation also needs to be properly disinfected.

Presentation:

BCG (Freeze-dried) Therapeutic is supplied in ampoules of 40 mg. each.

Storage:

The preparation should be stored below 8C and protected from sun light. It should be used

immediately after reconstitution. Reconstituted drug if not used immediately, should be discarded.

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History of BCG Vaccine Laboratory