USFDA highlights quality concerns over drugs manufactured in India

USFDA launches QMM program to reduce drug shortages and improve supply chain issues

The Center for Drug Evaluation and Research (CDER), a division of the US Food and Drug Administration (FDA), has expressed concern over the quality of drugs manufactured in India, asserting that it found violations at 11 per cent of the facilities it inspected in the country, the highest in any other global region, a senior official said.

Data integrity problems were found in bioavailability and bioequivalence studies conducted by contract research organisations (CROs). These data integrity issues found in Indian manufacturers, included falsified pharmacokinetic (PK) data which is the study of how the human body interacts with administered substances, deliberate distribution of subject data into distinct cohorts to pass the bioequivalence study, questionable practices in reanalysing samples schemes and deficiencies poor quality management of systemic procedures. 

 

Such persistent quality issues could tarnish the reputation of the generic medicine industry, and raise questions about the reliability of generic drugs, which comprise over 90 per cent of US prescriptions. USFDA emphasised the importance of strong quality culture and proactive problem-solving to maintain drug quality and public trust.

Patrizia Cavazzoni - Director, CDER, USFDA stated: “The FDA plays its part by collaborating closely with manufacturers to ensure that there is a strong quality culture in their organisations, and that everybody understands what is expected of them, and that is to operate with integrity and to the highest quality.” 

“We urge organisations to cultivate a culture where any concerns about data quality are promptly communicated to the FDA. This approach will allow us to address issues before they escalate into serious problems that could necessitate FDA actions, manufacturing interruptions, shortages, and other critical issues,” Cavazzoni said.

Concern was also raised over the entry of new manufacturers, including industrial firms, into the drug-making business. These newcomers often lack awareness of US regulatory requirements, leading to quality issues.

Cavazzoni called for stronger management support and a robust quality culture within pharmaceutical organisations to ensure continuous improvement in drug manufacturing standards.

The US FDA also revealed that they were piloting the Quality Management Maturity (QMM) programme to assess the quality culture of drug manufacturers. The FDA's QMM programme, highlighted at IPA's 9th Global Pharmaceutical Quality Summit 2024, aims to reduce drug shortages and improve supply chain resilience by promoting advanced quality management practices.

The QMM programme aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements

US FDA claimed the QMM programme offered advantages to patients, manufacturers, healthcare professionals, and the FDA itself. Patients can expect a more reliable supply of drugs with fewer recalls and shortages. Manufacturers can leverage the programme for continuous improvement and gain a competitive edge. Healthcare professionals will have access to medications needed by their patients, and pharmacies will face fewer risks of stockouts. Finally, the FDA will benefit from a risk-based approach to inspections, allowing them to focus on areas of higher concern.