The health ministry has assured the Parliamentary Standing Committee on Health and Family Welfare headed by Brajesh Pathak that the three public sector vaccine manufacturing units would be fully GMP compliant within a period of three years for which revamping of the existing production facilities at each location is in progress.


In its action taken report, the health ministry informed that the orders to suspend production at the Central Research Institute (CRI), Kasauli, the Pasteur Institute of India (PII), Coonoor and the BCG Vaccine Laboratory (BCGVL), Chennai were revoked in February, 2010.


“In CRI, Kasauli production of TT, Diphtheria, Yellow Fever Vaccine, AKD Tyhoid, ARS, DATS and ASVS has started in the existing facilities. Supply of DPT, TT, ASVA, and YF vaccine have been released for use. Upgradation of DPT facilities is also in progress,” the report said.


“In BCGVL, actions to rectify the deficiencies were initiated. However, the vendors left the work unfinished demanding payments. The matter had been resolved and administrative approval was issued amounting to Rs.24,770,282 for payments to the vendors for completion of the work relating to the rectification of deficiencies pointed out in the WHO-NRA report. Revamping has been carried out in old areas for production. Production of BCG vaccine started in July, 2010 afresh and the same could be released for commercial use only after the mandatory quality testing,” it said.


In BCGVL, the revamping of working condition in old areas of culture, quality control, quality assurance, washing sterlization, Physical verification of vials and animal house have been partially done. Standardization of the technical procedures has been completed. Filling area and packing have been identified to start the filling and packing work. New areas of culture, quality control- 30 per cent have been completed. Validation studies of bio-burden in old production are done. Regular filling has been done in FD-Hull and FD-SMH in September 2010 which was successfully completed. In this filling 83,139 vials have been freeze dried which comes to 8.3 lakhs doses.


“At Diphetheria Laboratory of PII, 14 batches of culture have been produced. Six batches have reached concentration and purification stage. A total dosage of 15.00 million doses at crude stage is available at present, which is sufficient to prepare 12.00 million doses of final vaccine after further purification. In Pertussis Laboratory, 26 batches of culture have been produced. Two pools were prepared. A total dosage of 10.00 million doses at crude stage is available at present, which is sufficient to prepare 8.00 million doses of final vaccine after concentration. In the Tetanus Laboratory, 14 batches of culture have been produced. Seven batches have reached concentration and purification stage. A total dosage of 25.00 million doses at crude stage is available at present, which is sufficient to prepare 20.00 million doses of final vaccine after further purification. In Gel & Mixing Laboratory, 22 batches of adjuvant (aluminium phosphate gel) have been prepared which is sufficient to formulate 12.00 million doses of DPT vaccine,” the report said.


In addition, all the critical production equipments are functional. Certain civil works like flooring, painting, and electrification are being carried out. Microbial air monitoring test was carried out by Quality Assurance Department and appropriate action initiated. Calibration of most of the equipments and the instruments are put into regular use. Critical raw materials are regularly being purchased. Breeding of Mice and Guinea pigs have been strengthened. Required Quality Control tests are being performed, the government said.


A feasibility study has been conducted and approval was granted to revamp the existing facilities at PII, Coonoor for making it GMP compliant. Since the existing facilities are more than 60 years old, the institute has been directed to study the structural feasibility for revamping the same for GMP compliance, the Panel was informed.