WHO sends Panacea to remediation

It's time to revise the revenue projections at Panacea Biotech. The World Health Organization, following a late June manufacturing plant inspection, has removed three of the drugmaker's combination vaccines from its pre-qualification list, meaning the WHO won't buy its drugs due to the sub-par manufacturing practices observed.

Inspectors found quality management deficiencies at Panacea's vaccine plant near Punjab, India. The vaccines in question include combinations of diphtheria, pertussis, tetanus, Hepatitis B and Hib B. Their final disposition awaits a decision on their acceptability for distribution by the United Nations, which will be made by a WHO-convened committee.

Panacea said the company has begun corrective measures and expects to soon apply for re-listing of the drugs. There are reportedly no quality issues with the vaccines already in the market.

The news is a blow to the vaccine industry in India, which Unicef named the low-cost supplier in most categories following a survey of supplier pricing data that the organization made public for the first time in June. Findings revealed nearly a $1 spread in the 2010 price for one vaccine sourced from 5 suppliers.

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