Drugmaker Sun Pharma has got six regulatory observations on its Halol factory in Gujarat from the US Food and Drug Administration, the company said, adding that it would respond in two weeks.

“The USFDA conducted a pre-approval inspection (PAI) of Sun Pharmaceutical Industries’ Halol facility from August 27, 2018 to August 31, 2018,” the company said, adding that the inspection concluded with the regulator issuing a Form 483 with six observations.

Non-compliance

The US regulator makes Form 483 observations when companies don’t adhere to procedures outlined in the Current Good Manufacturing Practices (CGMP) norms. Companies are expected to revert with their remedial action. But the issue could escalate if the action does not meet with the approval of the regulator. And Halol being an important plant for Sun Pharma, the regulatory action brings in an element of uncertainty.

Regulatory scenario

Earlier this week, the USFDA Commissioner Scott Gottlieb outlined his agency’s efforts to ensure that quality products got into the US market from foreign drug manufacturing facilities. “Over the past 25 years, globalisation of drug manufacturing has prompted the FDA to change its regulatory landscape,” he said, and as manufacturing of drugs and their components shifted to overseas production facilities, it brought in new complexities. “The FDA took steps to keep pace,” he added.

“We’ve established a framework to assure that all drug products meet the same high-quality standards, regardless of where they’re manufactured; and whether they’re brand-name or generic products, or prescription or over-the-counter drugs,” he said.

To bring in greater transparency around its site selection model, the agency is publishing a policy on how manufacturing facilities are prioritised and scheduled for surveillance inspections. “Our policy explains how a facility’s compliance history, recall trends, time since last inspection, inherent risk of the drug being manufactured, processing complexity and other factors are all weighed and considered,” he said.

Tracking compliance

In the financial year 2017, there were about 5,063 human pharmaceutical sites worldwide, subject to routine surveillance inspection — 3,025 of those were foreign-based. For that year, the FDA conducted 1,453 drug surveillance inspections, including 762 on foreign soil to ensure manufacturers were followingCGMP requirements and maintaining high quality standards, the note said.

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