USFDA Certification Is The Real Gold Standard: DG Shah
  • Elizabeth George
  • Sep 24 2013

September 24: “There are three types of scrutiny from the US and we have failed on all three counts,” says D.G. Shah, Secretary General at the Indian Pharmaceutical Alliance. The USFDA looks at data integrity, compliance with good manufacturing practices and product quality, he says, adding that the FDA must now change from being purely a forensic auditor to a trainer. The Indian pharma industry needs to work closely with the FDA to get the approvals and necessary training, he adds.