DIRECTORATE GENERAL OF HEALTH SERVICES

BCG VL Guindy

BCGVL Guindy was established in 1948 and currently 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, situated at Guindy, Chennai (Tamilnadu) near King Institute of Preventive Medicine. The institute has a huge complex, which is divided in five major sub-sections i.e. Establishment, Production Division, Quality Control Division, Animal House and Warehousing & Marketing. The other major facilities are Containerization, sterilization, Physical inspection.

Functions:

The major functions of the institute are production of BCG Vaccine (10 doses) for control of childhood Tuberculosis and supply to Expanded Programme of Immunization (EPI). Institute also manufactures therapeutic BCG Vaccine for management of bladder cancer.

Staff Strength

• sanctioned strength -113
• Staff in-position -95
• Requirement as cGMP -151
• Existing staff suitable -94
• New psts to be created -57

Budget Provisions:

• Budget Estimates 2015-16 -Rs. 2315.00 lakh
• RE (2015-16) proposed -Rs. 1684.00 lakh
• FE 2015-16 -Rs. 1465.00 lakh Actual expenditure 2015-16 -Rs. 1384.85 lakh
• BE (2016-17) proposed - Rs. 2255.00lakh

Physical Performance of BCG

• Installed capacity for production of BCG vaccine of 800 lakh doses per annum.
• The Institute was meeting 100% of demand of BCG vaccines in the country, since 2002-03.
• However, after the suspension of the manufacturing license in Jan., 2008, the production and supply of the BCG Vaccine from the institute was stopped.

Up-gradation of BCG vaccine manufacturing facility:

• MOH&FW has taken a decision in a meeting under the Chairmanship of Secretary (H) on 1.3.2011, wherein it was decided that the BCGVL will be revived and a new cGMP compliant BCG vaccine manufacturing facility will be created at the exiting site.
• SFC was approved for creation of new facility for manufacturing of BCG vaccine and for renovation of Allied facilities at BCGVL.
• Ms. HLL was engaged for up-gradation of BCG vaccine manufacturing facility at BCGVL Chennai and to make it cGMP compliant with a cost of Rs. 64.72 Crores.
• Status of completion of new facility as on date;
• Construction & Civil Works -Completed
• Purchase of equipments -Completed
• Installation Qualification -Completed
• Operation Qualification -Completed
• Validation -Completed
• DCG(I) Inspection -Completed
• Trial Batches -Planned from May 2016
• Consistency Batches -Planned from Oct 2016

Release of Funds to M/s HLL:

The status of Funds approved under the project and released to M/s HLL as on date are as under;

• Total Funds approved as per SFC Rs. 64.72 Crore
• Funds released till March 2015 Rs. 57.78 Crore
• Balancefunds to released Rs. 6.94 Cro