20 Sep 2013, BioSpectrum Bureau , BioSpectrum
New Delhi: India-based drugmaker Panacea Biotec said it is preparing to resume supplies of its pentavalent vaccine Easyfive TT to UN procurement agencies for global markets (UNICEF) with the World Health Organization (WHO) initiating arrangements for the same.
Easyfive TT (DTP-HepB-Hib) protects against diphtheria, tetanus, pertussis, hepatitis B and haemophilus influenzae type b (Hib) of early childhood. WHO has already informed the UNICEF of the positive outcome of the evaluation process and will be issuing the letter to UNICEF informing the pre-qualification of EasyfiveTT mono and multi-dose presentations and the details of pre-qualification will be published on WHO webpage soon.
The company also stated that it has successfully completed the audit of its Lalru (Punjab) and Baddi (Himachal Pradesh) facilities, conducted by WHO team from February 28 to March 01, 2013.
In August 2011, WHO had delisted three of the company's vaccines -- diptheria-pertussis-tetanus based combination vaccines Easyfive, Ecovac4 and EnivacHB -- from pre-qualified list of vaccines due to quality concerns.
Panacea Biotec joint MD Rajesh Jain said in a statement issued by the company that Panacea Biotec has put in a new quality management system at both the plants with focus on getting the organization ready for change to designing systems to prevent problems.