Panacea Biotec, a leading research based pharma company, has received World Health Organization (WHO) pre-qualification for its pentavalent vaccine Easyfive TT (DTP-HepB-Hib). WHO has also informed the UNICEF (the procurement agency for global markets) of the positive outcome of the evaluation process and will be issuing the letter to UNICEF informing the pre-qualification of Easyfive TT mono (one dose) and multi-dose (10 dose) presentations and the details of pre-qualification will be published on WHO webpage soon.

The company is now preparing itself to supply EasyfiveTT vaccine (pentavalent vaccine that protects against five diseases – diphtheria, tetanus, pertussis, hepatitis B and haemophilus influenzae type b (Hib) of early childhood) to UNICEF and other international agencies involved in procurement of vaccines at global as well as national levels in various countries.

Dr Rajesh Jain, joint managing director, said, “It was a great experience to have worked with every individual involved in vaccines operations at both Lalru and Baddi sites in rebuilding our new quality management system. The whole effort was focused right from getting the organisation ready for change to designing systems to prevent problems. Paying attention to even small issues like house-keeping rules, meeting discipline were as important as re-designing every single work flow design.”

Jain added, “We had focused on getting our thinking process right and move from paper quality to robust QA system ensuring patient safety as our key goal. Today, the company internally has subject matter experts and the champions on every aspect of Quality Management System”

Panacea developed and introduced the world's first fully liquid pentavalent vaccine in the year 2005 and achieved WHO pre-qualification in July 2008. Since then until June 2011, the company had supplied over 45 million doses for usage in around 31 GAVI/non-GAVI countries worldwide.

Fully liquid pentavalent vaccine continues to be a high priority vaccine for WHO, UNICEF and GAVI. As per the GAVI forecasts, the overall demand for pentavalent vaccine is expected to increase to over 234 million doses by 2016 and thereafter 256 million doses by 2019 for all the 73 GAVI eligible countries.