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WHO has delisted Panacea Biotec’s DTP-based combination and monovalent hepatitis B vaccines from its list of pre-qualified vaccines. 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.
Following a routine site audit conducted by a WHO team, of the manufacturing facility of PanEra Biotec at Lalru, which is the associate Company, and the conclusions of an ad-hoc committee convened by WHO, the Company's diphtheria-pertussis-tetanus based combination vaccines i.e 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.
Specifically, deficiencies in the Quality Management System were 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.
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.
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.
Panacea Biotec is one of India’s leading research based health management companies with established research, manufacturing and marketing capabilities.
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MoneyWorks4Me rating and ranking of funds for SIP is available to subscribers only. Moneyworks4Me is not a rating and ranking agency, however it is required that users have a way of selecting funds and building a Portfolio. The method used by it are described below to enable users to understand the logic behind the rating and ranking Subscriber will find more details on this in the various content made available from time to time. In case you need more please write to besafe@moneyworks4Me.com
MoneyWorks4Me rates and ranks mutual funds based on the following data-driven system:
Funds ranking in screeners: Performance Consistency and Quality are two parameters used for ranking funds for SIP. The ranking as follows GG, GO, GR, OG, OO, OR, RG, RO and RR.
With the same color-coded funds, the one with the higher Average 3-year rolling returns (over 5 to 10 years), the number that appears in the Performance tag, ranks higher.
Here is the summary:
The third tag Upside Potential is not relevant for SIP. It is relevant for lumpsum investments in Mutual Funds.
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