Sal Pharma and Pan Drugs gets FDA warning letter for not registering drugs

NEW DELHI: Two small Indian companies Pan Drugs and privately-held Sal Pharma have got Warning Letters from American drug regulator for not fulfilling the mandatory registration requirements.

The US Food and Drug Administration (FDA) had earlier pointed out to both the Indian companies regarding their non compliance to the US registration laws, but the companies did not take adequate corrective steps, FDA said.

While Hyderabad-based Sal Pharma got the Warning Letter in April, Vadodara-based pan Drugs was pulled up in February, according to the USFDA website latest notification.

The companies have to respond to the FDA in writing within 15 days specifying the corrective actions it will take. Though the warning letter in itself does not impact the operations of the company, the FDA can take harsh actions, including preventing the companies from selling their medicines in the US, if the companies' actions are not satisfactory.