Cadila Healthcare confirms WHO notice of concern in BSE filing

By Gareth Macdonald contact

- Last updated on GMT

Cadila Healthcare confirms WHO notice of concern in BSE filing

Related tags: Quality control, Implementation

Cadila Healthcare has confirmed receipt of a notice of concern (NOC) about its vaccine plant in Moraiya, India five months after the WHO inspectors criticized operations.

The firm ​ part of the Zydus Group - first acknowledged the NOC in a Bombay Stock Exchange (BSE) filing​ on March 22, stating that: “We have already responded to [the] WHO and have been implementing remedial measures. There is no significant impact on the business​.”

The filing followed a month after the World Health Organization (WHO) published the NOC document, which provides details​ of good manufacturing practices (GMP) deviations observed during its visit to the facility in October last year.

Specific WHO criticisms included that Cadila failed to record environmental monitoring data and logged fake quality control and contamination reports.

A WHO spokesman told us “The NOC was sent to Cadila on Fri 27/11/2015. Following a response from Cadila, a revised NOC was issued to Cadila on 02/02/2016.

A meeting was held with Cadila on 03 February 2016 to discuss the contents and reasons for the revised NOChe said adding that during the meeting the firm was informed that the NOC would be published and available to stakeholders outside the WHO and UNICEF.

Cadila did not provide investors with details of the remedial measures it has implemented in its BSE filing

However, according to the WHO notice, the firm stopped making its rabies vaccine Lyssavac-N shortly after the inspection in October and recalled all batches made since April 2015.

The Indian drug firm also plans to implement Lonza’s Moda paperless quality control (QC) at the facility by the end of the year and has hired McKinsey & Co to help it develop a “quality culture” at the site according to the WHO.

Cadila did not respond to a request for comment ahead of publication.

Related topics: Markets & Regulations, Regulations, QA/QC

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