(Image source from: Sun Pharma plant in Gujarat banned by FDA})

US Food & Drug Administration has banned imports from a drug manufacturing facility of Sun Pharmaceutical Industries in Karkhadi, Gujarat. The antibiotic cephalosporin is produced by the particular plant.

Sun Pharma is one of the largest drug manufacturers in India. The latest ban is part of the ongoing crackdown against poor-quality foreign drug manufacturing companies.

An official of the firm said the ban was imposed after a recent inspection of the facily that fell short of FDA regulatory standards known as current Good Manufacturing Practices, or cGMP. The official said that a very small portion of Sun’s sales is produced at the Karkhadi facility.

The agency did not specify the manufacturing deficiency but apparently the nature of the problems were quite serious, said Peter Saxon, president of Saxon International Associates. Saxon's company, based in New Jersey, advises companies over cGMP compliance.

According to Saxon, FDA issues import alert in case a firm uses false documents or if the agency finds gross contamination in production.

India has emerged as one of the leading suppliers of generic drugs to the US in recent years. However, with the growing presence of Indian pharma companies in the US, FDA has been finding increasing instances of deficiencies in drug manufacturing at some of the facilities.

Earlier, Ranbaxy Laboratories (in 2012) paid $500 million fine over problems identified at some of its plants. Then in December, Wockhardt found itself banned by FDA.

Due to the increasing import of drugs from India, FDA is increasing its presence in the country. At present the agency has 12 drug investigators in India. Another seven are being recruited by the agency to strengthen its presence.

(AW: Pratima Tigga)