Data integrity issues hamper relations with regulators: Strides

The Indian pharmaceutical industry has been reeling under regulatory issues over last few months. Before coming to a decision, one needs to see what type of observations have been made, says Arun Kumar, Founder & MD of Strides Shasun. Speaking to CNBC-TV18, Kumar says observations are primarily of two types. “If you get a Form 483, which is to do with data integrity, then you have lost the trust of agencies.” “We, as in industry, are trust deficit now,” Kumar says. This is when remediation comes in and a third party is brought to look into the situation. The trust of the regulator, in this case, is lost, he says. But, a 483 for a skill or equipment is more of a corrective measure and is easy to address. The recent establishment inspection report (EIR) is conclusive inspection reports. If the company’s dossier is well, then approvals will start coming in. However, you may have a great inspection but your product dossier may not be good, which could be the reason for delays in products, Kumar adds.