IGMPI India

Surprise Inspection is being conducted by US FDA at Dr Reddy's Laboratories unit located at Vishakhapatnam since Tuesday evening. The surprise check by the regulator is at the chemical technical operation (CTO) unit VI, which manufactures both active pharmaceutical ingredients (APIs) and bulk drugs.

The unit is meant for supplying drugs to European and US markets. During the inspection some discrepancies have been found by the US regulator which is expected to be given as recommendations to the company.

Recently in a lawsuit wherein Ranbaxy had sued the US FDA for revoking the key exclusivity period of two of its major drugs Nexium and Valcyte in the US market, Dr Reddy's intervened in the lawsuit inclining toward's FDA and against Ranbaxy. Dr Reddy's was granted permission to launch the Valcyte generic after the order of Ranbaxy gets revoked.

Surprise plant inspections and import alerts have become frequent as a result of strict monitoring of major Indian Pharma's over compliance issues. Several Indian manufacturing plants of major pharma companies such as Ranbaxy, Sun Pharma, Wockhardt and Strides Arcolab have come under the FDA's scanner on compliance issues.

The frequencies of regulatory inspections have increased in the recent years. Some examples include- unannounced inspection at Sun Pharmaceutical Industries' Halol unit in the month of September this year by US FDA, issuance of warning letters by FDA due to Cgmp violations at the manufacturing unit of Sun Pharma at karkadi and Gujarat