More reports on: World Health Organisation
Panacea loses drug contract with WHO over quality issues news
19 August 2011

The World Health Organisation (WHO) has removed three combination vaccines made by Panacea Biotech from its pre-qualification list; which means it will no longer buy drugs from the Punjab-based company.

It said it took the step after it found deficiencies in the quality management system at Panacea's vaccine manufacturing facility in Lalru, Punjab.

Shipments of these vaccines combinations of diphtheria, pertussis, tetanus, Hepatitis B and Hib B vaccines has been put on hold until a final decision on the acceptability for United Nations supply is made by a WHO-convened ad hoc committee.

The de-listing follows an inspection of the plant carried out by another WHO panel between 27 June and 1 July, which recommended the move. The ad-hoc committee will review the findings of the audit team.

This means that Panacea will lose UNICEF and the Pan American Health Organisation, which supply such pre-qualified vaccines to the developing countries, from its list of buyers, at least for now.

Panacea said in a statement on Thursday, "The company's diptheria-pertussis-tetanus based combination vaccines Easyfive, Ecovac4 and EnivacHB have been de-listed by the WHO from its list of pre-qualified vaccines.

Panacea said the company has already initiated corrective measures and was confident of completing the process soon, when it will apply for re-listing these drugs.

Both the company and WHO said there are no quality issues with the vaccines already in the market, and there is no need to recall these.

The company did not give an estimate of the revenue loss expected from the delay in supplies, although its shares slumped immediately after the news. A company spokesman said it is in the process of evaluating the financial impact of the delisting.

Panacea's main revenue earner - oral polio vaccine (OPV) - will continue to be accepted by WHO, since the formulation and filling of the OPV vaccines is carried out at its New Delhi plant, where WHO has no evidence of inadequate quality assurance.

But an audit by a WHO team of the New Delhi site is scheduled for the coming weeks.

If the company is unable to resolve the issue soon, it may cost the firm a part of the $222-million WHO contract that it had bagged in 2009.

In a similar situation a year ago, WHO had suspended the pre-qualification granted to a vaccine manufactured by Shanta Biotechnics. Despite implementing corrective measures, the company is yet to be re-qualified for supply to international markets.





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Panacea loses drug contract with WHO over quality issues