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| Exchange Disseminated Time | Panacea Biotec Ltd has informed BSE regarding "WHO delist Company's DTP-based combination and monovalent hepatitis B vaccines from its list of pre-qualified vaccines"
"Following a routine site audit conducted by a WHO team, of the manufacturing facility of PanEra Biotec Pvt. Ltd. (our associate Company) at Lalru, and the conclusions of an ad-hoc committee convened by WHO, the Company's following diphtheria-pertussis-tetanus based combination vaccines: Easyfive (DTwP-Hep B-Hib), Ecovac4 (DTwP-Hep B), and EnivacHB (Hepatitis B), have been delisted by WHO from its list of pre-qualified vaccines.
During the site audit, which took place recently at the Lalru manufacturing site, it became clear to the WHO team that Quality Systems on this site do not meet the requirements required for WHO prequalification.
Specifically, deficiencies in the Quality Management System found at the Lalru site related to the manufacture of the haemophilus influenza type b (Hib) and hepatitis B bulks used for the formulation of the DTwP-Hep B-Hib, DTwP-Hep B and hepatitis B vaccines.
WHO has, however, stated that there is no evidence of quality or safety defects with batches of these vaccines already distributed and hence these Batches should not be recalled and should continue to be used. WHO's recommendation for such continued use emanates from the available evidences which include: testing by WHO-contracted laboratories that has been performed on batches of Panacea vaccines that have been supplied through the UN system in accordance with the continuous monitoring performed by WHO on prequalified vaccines; and review of complaints and reports of adverse events following immunization from either immunization programmes, national regulatory authorities or the manufacturer.
Further, the Company's other four oral polio vaccines (tOPV, mOPVl, mOPV3 and bOPV) remain pre-qualified products and WHO has recommended the continued supply of the OPV vaccines.
Even for Easyfive (DTwP-Hep B-Hib), Ecovac4 (DTwP-Hep B), and EnivacHB (Hepatitis B), WHO has committed to reassessment of these products for prequalification as soon as appropriate corrective measures have been taken by the manufacturer." |
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