Delhi-based biotechnology company Panacea Biotec is awaiting a nod from the World Health Organization (WHO) to resume supplying vaccines for the world immunisation programme from its units at Lalru (Haryana) and Baddi (Himachal Pradesh).
Speaking to Business Standard, a senior company official said, “We expect WHO officials to visit our units in Lalru and Baddi for prequalification next month. Recently, we had shifted the Easyfive pentavalent vaccine to our new unit in Baddi and once the plant is approved by WHO, we will be able to resume supplies for its immunisation programme.”
Prequalification is a process through which pharmaceutical and biotechnology companies have to meet certain WHO-stipulated conditions and standards to be eligible to supply vaccines to United Nations’ procurement agencies globally.
Companies are able to bid for WHO tenders to supply drugs only if their vaccines are in the list of prequalified vaccines. Panacea manufactured the five-in-one vaccine — used to treat diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B in children — at its unit in Delhi and the raw material at the Lalru unit.
However, in mid-2011, WHO delisted the Lalru unit, citing irregularities and deficiencies in the plant’s quality management system.
Consequently, three of the company’s diptheria-pertussis-tetanus-based combination vaccines — Easyfive, Ecovac4 and EnivacHB — were also delisted from WHO’s list of pre-qualified vaccines.
The official said Panacea had undertaken various measures to refurbish the facility and strengthen its quality management system, adding the company was confident of getting an approval from WHO.
In March 2012, Panacea had voluntarily withdrawn its oral polio vaccine, or OPV, (also produced at the company’s Delhi facility) from WHO’s list of pre-qualified vaccines, saying the manufacturing unit needed corrective action.
While Panacea lost a chunk of the $222-million, three-year WHO contract to supply the Easyfive vaccine to UNICEF (United Nations International Children’s Emergency Fund) till 2012, a prequalification of the vaccine during visit of WHO officials may help it grab the next supply deal.
Currently, Panacea supplies its OPV to the domestic market from the Delhi unit. The production of Easyfive has been shifted to the new facility in Baddi.
