Data Integrity A Persistent Issue With Indian Pharma Plants, Says U.S. FDA's Sarah McMullen

Data integrity is a persistent issue among Indian pharmaceutical plants with compliance problems, even as there are now fewer instances calling for 'official action', according to the India head of the U.S. Food and Drug Association.

Data integrity is a crucial tool to ensure that manufactured drugs are safe, effective and fulfill quality standards, Sarah McMullen, country director, FDA, told NDTV Profit in an interview. It, she said, is indicative of "quality culture".

Most facilities in India are old, according to McMullen. "Age and upkeep of the facility, especially in sterile products, seem to be an issue."

She expects the industry to invest more in quality improvement.

Indian pharmaceutical companies have seen plant inspections go up two and a half times post Covid, but the issue of 'Official Action Indicated' status has reduced, McMullen said.

This is a positive for Indian pharma companies exporting to the U.S. because it means that there is "increased compliance" and more facilities are up-to-date with respect to the required quality standard maintenance.

'OAI' status means that the plant is considered to be in an unacceptable state of compliance with current good manufacturing practices. The regulator recommends remediation and corrective measures in such cases, which then require reinspection.

Observations in Form 483, issued to facilities post-inspections, are listed in the order of high to low risk, McMullen explained. Ever-evolving technology and innovation bring newer risks to the fore, leading to changing standards, she said.

With an increasing number of facilities requiring inspection, reinspection and pre-approval inspections for drug products and an overall ramp-up in the number of facilities vying to export to the U.S., the regulator is looking to ramp up staff in India, McMullen said. "With the increasing workload, we are requesting more drug inspectors in India to meet the increasing demand."

Watch the full conversation here: