Re: Closure of Vaccine PSUs in India:more about BCGVL:Attn Anupama

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Dear NETRUMians,

Dr Anupama has given another valuable posting to make this discussion interesting.

here is some more information about BCGVL

source: http://mohfw.nic.in/dghs.htm

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@...

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@...

Phone

234 2976, 234 1745

Fax

234 9947

Name of the Officer

Shri T.Shameem Ahmed

Designation

Refrigeration Engineer

E-mail

bcglab@...

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

3) 3) Production of Purified Protein Derivative RT – 23 (Mantoux Reagent) for diagnosis of Tuberculosis and supply to needy medical faculties and Organizations.

4) 4) To act as National Quality Control Laboratory for BCG Vaccine

HISTORY OF BCG VACCINE LABORATORY, CHENNAI

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. 2. Change over of Manufacture

3.

a) a) Liquid to Freeze Drying

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) 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) 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) 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) (1) Quality vaccine output and change of Technology

(2) (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.

( 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.

© 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. 1. Freeze Driers.

2. 2. Cold Rooms.

3. 3. Autoclaves.

4. 4. Clean room facility at Class 10,000 level.

5. 5. Laminar Flow Benches at Class 100 level.

6. 6. Vial filling & vial capping machines.

7. 7. Blister forming machineries.

4. 3. TRAINING FACILITIES WITH DETAILS:

(a) (a) TRAINING OF THE BCG STAFF:

(

1. 1. Training in CRI Kasauli, towards cGMP on Vial Technology and Machinery utilisation, Water Treatment Plant, Packing related Machinery.

2. 2. Training on “Uncertainty in Measurementsâ€.

3. 3. Lead Auditor Training Programme on ISO 9001:2000

4. 4. “Issues and Problems on Animal Experimentation – A challenge to medical researchâ€.

5. 5. Technical Workshop on Establishment Rules.

6. 6. In House Training in the manufacture of BCG Vaccine.

© ( TRAINING OF OUTSIDERS:

(d)

1. 1. Documentation and lecture on BCG application to Medical and Non-Medical Students from various Universities.

2. 2. Training the University students on Research in BCG.

5. 4. IMPORTANT ACHIEVEMENTS

1) 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

BUDGET ALLOCATION

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) 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.

ISO 9002 CERTIFICATION

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) 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.

6. 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

7.

8.

9.

(DR.N.ELANGESWARAN)

DIRECTOR

From: Vijay <drvijaythawani@ .co. in>Subject: Re: Closure of Vaccine PSUs in Indianetrumgroups (DOT) comDate: Sunday, 3 August, 2008, 6:20 AM

Hi,If the "WILL" to do is lacking, then nothing can help. In this case , as is being exposed, the vested interest spoiled the show.Will someone search and post what exactly the WHO said in respect of these vaccine manufacturing units?Vijay>> > Hello sir,> > One of the major issues that came up during WHO reviews in 2001 and 2004> was the lack of complaince to GMP as recommended by WHO itself. After> that the last assessment was done in 2007, three years later, and the> senario was the same. Dont you think that the period of three years was> queit sufficient to improve the quality of manufacturing practices when> there was 'do or die' conditions for PSUs?>

> Regards> > Dr. Swapnil Jaiswal,> > Pharmacology Dept.,> > Government Medical College, Nagpur.>

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