BCG VACCINE LABORATORY
GUINDY, CHENNAI-32
1.
NAME,
DESIGNATION, E-MAIL, PHONE AND FAX OF
THE OFFICERS UPTO THE RANK OF DDA/DEPUTY SECRETARY:
|
Name of the Officer |
Dr.N.Elangeswaran |
|
Designation |
Director |
|
E-mail |
bcglab@md4.vsnl.net.in |
|
Phone |
234 2976, 234 1745, 231 1906 |
|
Fax |
234 9947 |
|
Name of the Officer |
Dr. K.Meenakshi, |
|
Designation |
Deputy Assistant Director
(Medical) |
|
E-mail |
bcglab@md4.vsnl.net.in |
|
Phone |
234 2976, 234 1745 |
|
Fax |
234 9947 |
|
Name of the Officer |
Shri T.Shameem Ahmed |
|
Designation |
Refrigeration Engineer |
|
E-mail |
bcglab@md4.vsnl.net.in |
|
Phone |
234 2976, 234 1745 |
|
Fax |
234 9947 |
2. DETAILS OF
AVAILABLE FACILITIES & IMPORTANT ACTIVITIES OF ATTACHED/ SUBORDINATE
OFFICES:
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. The activities of this Laboratory
are:
1) Manufacture of Freeze
Dried BCG Vaccine (2O doses) for the control of childhood Tuberculosis and
Tuberculosis Meningitis in children and supply to Expanded Programme of
Immunization (EPI) of the Government of India and to other needy medical
faculties.
2)
Manufacture and
supply of Freeze Dried BCG Therapeutic
Vaccine (40mg) for cancer chemotherapy especially Carcinoma of Urinary
Bladder all over the country
3)
Production of Purified
Protein Derivative RT – 23 (Mantoux Reagent) for diagnosis of Tuberculosis and
supply to needy medical faculties and Organizations.
4)
To
act as National Quality Control Laboratory for BCG Vaccine
1. Introduction
BCG
Vaccine Laboratory, Chennai was established on 1st May 1948, to
produce and supply liquid BCG Vaccine
and Tuberculins with the help of Statens Serum Institute (SSI), Copenhagen,
Denmark through World Health Organization (WHO). The strain used was DANISH –
1331 strain.
2. Change over of Manufacture
a)
Liquid to Freeze
Drying
b) 50 dose/ampoule to 20 dose per ampoule
Due to short shelf life of liquid BCG Vaccine, this
Laboratory started manufacturing Freeze Dried Vaccine with shelf life of 2
years along with liquid vaccine in the form of 50 dose ampoules. In view of
unique advantages of Freeze Dried BCG Vaccine over the liquid vaccine, BCG
Vaccine Laboratory, Chennai switched over completely from liquid vaccine to
Freeze Dried Vaccine during 1973. Till July, 1982, the vaccine was manufactured
in 50 dose ampoules. As this lead to wastage during immunization, this
Laboratory switched over to manufacture the vaccine in 20 dose ampoules to
avoid loss due to wastage in the field. From August 1982, the manufacture was
completely switched over to 20 dose ampoules only.
3) Seed Preparation:
The State Serum Institute, Copenhagen supplied the BCG Seed to BCGVL, Chennai through WHO to manufacture the vaccine upto 1993. Subsequently, due to some reasons, they were not in a position to supply the seed. Hence, BCGVL Chennai prepared its own seed lot which may be for more than 20 years. As a result, this Laboratory stopped the import of BCG Seed. It is called MADRAS WORKING SEED LOT (MWSL).
4) Installed capacity:
The installed capacity in this Laboratory as on 1998 for
production of BCG was 400 lakh (40million) doses whereas the country need was
550 to 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.
5)
Important
achievements during 1998-99
The following agenda were made at BCGVL to improve its
facility to attain self sufficiency in
the BCG Vaccine production, so that
import can be stopped and uniformity of supply can be made from ampoules to
vials:-
(1) Quality vaccine output and change of Technology
(2) International accredition of the Laboratory
To achieve the above agenda the following actions were
taken:-
(a) Augmentation of BCG production
1)Complete utilization of the BCG Culture produced
2)Expansion/modernization of the existing
Laboratory with change of
Technology
3)International accredition
including meeting the requirements
of cGMP of WHO.
(b)
Complete utilisation of BCG Culture produced
Previously before 1998-99 the same
amount of BCG Culture were produced. But due to some reasons the suspensions
were not completely used. After 1999-2000, the same amount of culture were
prepared and utilised completely.
Decreased the loss during the vaccine manufacture in
ampoules.
(c) Expansion/modernization of the existing
Laboratory
The installed capacity of this Laboratory is 400 lakh doses.
To increase the installed capacity, this Laboratory procured two new Freeze
Driers – one number each of Hull Production Freeze Drier and Ultra Pilot Freeze
Drier with Vial Stoppering facility during 1999-2000. By purchase of these
equipments, this Laboratory is switching over to manufacture BCG Vaccine in
Vials from ampoules by which vaccine loss during sealing of the ampoules may be
reduced and in turn the production quantity will increase. Also Vial
Stoppering facility will lead to reduce the expenditure of electricity, consumables like Siliconite
rods and Tiles. As on date this i.e from 1999-2000 onwards, this Laboratory
has attained “self sufficiency in the production of BCG Vaccine” and the import of vaccine through UNICEF has been
completely stopped.
This Laboratory has the following
infrastructure equipments:
1.
Freeze Driers.
2.
Cold Rooms.
3.
Autoclaves.
4.
Clean room facility
at Class 10,000 level.
5.
Laminar Flow Benches
at Class 100 level.
6.
Vial filling &
vial capping machines.
7.
Blister forming
machineries.
3.
TRAINING FACILITIES WITH DETAILS:
(a) TRAINING OF THE BCG STAFF:
1.
Training in CRI
Kasauli, towards cGMP on Vial Technology and Machinery utilisation,
Water
Treatment Plant, Packing related Machinery.
2.
Training on
“Uncertainty in Measurements”.
3.
Lead Auditor Training
Programme on ISO 9001:2000
4.
“Issues and Problems
on Animal Experimentation – A challenge to medical research”.
5.
Technical Workshop on
Establishment Rules.
6.
In House Training in
the manufacture of BCG Vaccine.
(b) TRAINING OF OUTSIDERS:
1.
Documentation and
lecture on BCG application to Medical and Non-Medical Students from various
Universities.
2.
Training the
University students on Research in BCG.
4.
IMPORTANT ACHIEVEMENTS
1) Attaining the
self sufficiency and stoppage of Imported BCG Vaccine for the supply to EPI.
DETAILS OF PRODUCTION &
SUPPLY OF BCG (2MG)
(Figures in Lakh doses)
|
Year |
Production
|
Order
placed by MHFW for EPI |
Supply
to EPI |
Private
Supplies |
Revenue
earned |
||
|
Indigenous |
Imported |
Total
|
|
|
|||
|
1998-99 |
242.27 |
536.17 |
315.96 |
180.47 |
496.43
|
8.39
|
2.84
crores |
|
1999-00 |
527.35 |
470.00 |
333.57 |
138.08* |
471.61
|
8.73
|
3.00
crores |
|
2000-01 |
637.64 |
608.80 |
575.41 |
47.61* |
623.02
|
7.53
|
7.85
crores |
|
2001-02 |
543.68 |
549.72 |
520.72 |
--- |
520.72
|
8.90
|
6.12 crores |
* Balance
stock available in the previous year supply
DETAILS OF
PRODUCTION & SALES OF BCG (40MG)
|
Year |
Production |
Sales |
Revenue
earned ( in Rs) |
|
1998-1999 |
21,934 |
20,705 |
24,84,600 |
|
1999-2000 |
22,764 |
22,970 |
27,56,400 |
|
2000-2001 |
57,152 |
35,927 |
46,70,510 |
|
2001-2002 |
1,61,630(including
vials & Ampoules which are under test) |
23,916 |
38,26,560 |
DETAILS OF
PRODUCTION & SALES OF PURIFIED PROTEIN DERIVATIVE (PPD I TU) (in vials)
|
Year |
Production |
Sales |
Revenue Earned |
|
1998-1999 |
19,300 |
22,798 |
Rs.
5,69,950 |
|
1999-2000 |
22,580 |
25,318 |
Rs.
6,32,950 |
|
2000-2001 |
28,340 |
32,116 |
Rs.
8,02,900 |
|
2001-2002 |
12,331 |
21,684 |
Rs.10,84,200 |
|
Year |
Plan |
Non Plan |
Total |
|
1998-99 |
1,50,00,000 |
2,39,19,277 |
3,89,19,277 |
|
1999-00 |
1,79,68,220 |
2,82,89,629 |
4,62,57,849 |
|
2000-01 |
49,99,543 |
2,92,09,581 |
3,42,09,124 |
|
2001-02 |
1,00,00,000 |
3,00,00,000 |
4,00,00,000 |
2) International
accredition of the BCG Vaccine Lab., Chennai like ISO 9002 to get the
International Accredition including WHO cGMP requirements.
New Standard Operating Procedures (SOP’s)
were made for all sections and all areas of manufacture including Stores has
been introduced. Based on that this Laboratory obtained ISO-9002, for its Quality System Management, a form of
International Accredition.
M/s
Bureau Veritas Quality International (BVQI), London has awarded ISO 9002:1994
certificate to BCG Vaccine Laboratory,
Chennai. This is the first and the
only Institute under the Ministry of Health & Family Welfare which has been
awarded ISO 9002 Certificate.
3) Attempt to
Marketing & Export of BCG Vaccine:
Since this Laboratory is receiving requisitions from Organisations abroad for purchasing of BCG Vaccine from this Laboratory, action is being taken to export excess quantity of BCG Vaccine to foreign countries, for which the approval of Directorate General of Health services, New Delhi has been obtained in August. Also DGHS has been approached to market the BCG 40mg vaccine in the local market by which the patient gets the vaccine through the stockiest. It is pertinent to mention here that by marketing of 40mg BCG Cancer Vaccine, this Laboratory will earn a revenue of approximately Rs.1.5 crores to 2 crores.
BCG Vaccine Lab.
| 5. IN CASE OF TEACHING INSTITUTION – {DETAILS ABOUT GRADUATE & PG COURSES:} | is neither a Teaching Institution |
| 6.
IN CASE OF HOSPITALS –
{IMPORTANT HOSPITAL
STATISTICS AND CITIZEN CHARACTER
:} |
nor a Hospital |
Dated: 20th
May, 2002
(DR.N.ELANGESWARAN)