Indian generic drugmaker Sun Pharma gets Food and Drug Administration shocker

MUMBAI: In a major setback to the Indian generic drugmaker Sun Pharma, the US Food and Drug Administration (FDA) has banned imports from the company’s plant at Kharkhadi in Gujarat for not adhering to good manufacturing practices. The company makes active pharmaceutical ingredients and formulations from its facility at Kharkhadi.

The latest import alert has raised serious concerns about the quality of drugs manufactured by the domestic pharma industry as several other Indian drug manufacturers have also come under the scanner of the US FDA in the past. For Instance, the US drug regulator had earlier banned imports from all the Indian plants of Ranbaxy over quality issues while orival drug manufacturer Wockhardt has also been banned from supplying drugs from some of its plants to the US and UK markets.

“This import alert was issued by the US FDA as a followup to the last inspection of the facility, during which some non compliance of good manufacturing practice regulations were identified,” the company said and added that the contribution of its Kharkhadi plant to Sun Pharma’s consolidated revenues is negligible.