Diphtheria, Pertussis & Tetanus Vaccine Rendered Unusable

About 300 lakh doses of the diphtheria, pertussis and tetanus (DPT) vaccine meant for children have been rendered unusable after an international inspection revealed that substandard component, tetanus toxoid was added to the triple vaccine at the Pasteur Institute of India, Coonoor. The loss because of the spoilt vaccines and their vial monitor labels, now rendered useless, is estimated to be Rs 8.5 crore. The loss will force the government to buy the vaccine from private labs at a higher cost.

Following the inspection,Tamil Nadu Directorate of Drugs Control on 28 December 2010 rejected Pasteur’s application for the World Health Organisation’s (WHO) good manufacturing practices (GMP) certificate.

The Drug Controller General of India had cancelled the manufacturing licences of Pasteur Institute, BCG Lab and the Central Research Institute on 15 January 2008 citing non-adherence of good manufacturing practices as the reason. The suspension was however revoked on 22 February 2010 to enable the labs to carry on with production using materials in the pipeline and upgrade themselves to WHO GMP standards before resuming full-fledged production. In March 2010, following an enquiry from the Health Ministry Pasteur Institute committed to supply 320 lakh doses of DPT vaccine and went into manufacturing mode even before getting the GMP certificate. In early December 2010 50 lakh doses of the prepared vaccine from Pasteur Institute were tested before being filled into vials and were found unusable.