Pharmaceutical major Pfizer has suspended production at its Irungattukottai facility near here after a team of global regulators found deviations from good manufacturing practices at the site.

Pfizer is the latest addition to an expanding list of drug makers found deviating from good manufacturing practices in India. In the last week of June, a high profile team drawn from world’s four leading regulators identified a number of deficiencies at the company’s Irungattukottai facility, near Chennai. Pfizer has temporarily stopped production at the site.

Generic injectable drugs are being produced at the facility.

It was earlier served a warning by the US Food and Drug Administration (FDA), and this was followed up with a handful of observations.

The inspection team was led by UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The US FDA, Therapeutic Goods Administration of Australia and Health Canada, the Canadian drug regulatory agency, were also represented on the team.

Pfizeer said that it had “temporarily paused production at the site to allow an assessment of observations by appropriate experts…The temporary pause in manufacturing is being utilized to review the observations, to develop a holistic improvement plan and also to provide additional training to our colleagues at the site”.

Source: http://health.economictimes.indiatimes.com


Guide to approaching a consumer court

India's first practical guide to resolving your complaints by approaching consumer court. Guidance
Customer Complaint

Newsletter

Enter your email address to subscribe to our Newsletter.