Easyfive TT vaccine to be back in WHO list: Panacea Biotec

In Aug 2011, WHO had delisted three of the company's vaccines from pre-qualified list of vaccines due to quality concerns

Drug maker Panacea Biotec today said it is hopeful of resuming supplies of its pentavalent vaccine 'Easyfive TT', which among other things, prevents Tetanus and Hepatitis B, to UN procurement agencies with the WHO initiating arrangements for the same.

The company's facilities at Lalru and Baddi have been audited by World Health Organisation (WHO) from February 20, 2013 to March 1, 2013 and they (WHO) are initiating the arrangements for pre-qualification (PQ), Panacea Biotec said in a statement.

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.

Commenting on the development, Panacea Biotec Joint MD Rajesh Jain said the company has put in a new quality management system at both the plants with focus on getting the organisation ready for change to designing systems to prevent problems.

Exuding confidence on resuming supplies of vaccines after WHO nod, Jain told PTI: "There is a huge demand for the pentavalent vaccines and besides a demand of 122 million doses that are unawarded by UNICEF for 2014-16 period, we are also looking at demand from several countries including India."

Panacea said WHO has also informed UNICEF about the positive outcome of the audit and will be issuing the letter to it informing the PQ of the company's EasyfiveTT vaccines.

'Pre-qualification' is a process under which drug companies have to fulfil certain WHO-stipulated conditions to become eligible to supply vaccines to UN procurement agencies globally.

The company said it is now preparing to supply 'Easyfive TT 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.

"Besides India, the countries that we are targeting are Nigeria, Egypt, Philippines, Syria among others," Jain said.

On being asked the financial cost of the corrective measures the company undertook for relisting, Jain said: "It is difficult to quantify the expenditure. The major effort was to strengthen the system and governance."

Besides domestic market, the company is looking at foraying in the Australian market for future expansion, besides increasing the presence in the international markets it is already present, Jain said.