US FDA is worried about the rise in non-compliance by Indian drug makers

“Globally, there are always concerns with quality. But in India, specifically, we are seeing a high number of facilities that are non-compliant. But we also would expect and hope that over the two years of the pandemic, some of the corrective actions could have been implemented in a way that would have been more consistent with maintaining a state of quality in the facilities,” she said.

The lack of compliance in Indian facilities has been a subject of growing concern. Non-compliance not only poses risks to public health but also undermines the reputation of the pharmaceutical industry. One of the critical issues contributing to this problem is the absence of a strong quality culture. Inadequate emphasis on quality assurance measures and practices has resulted in facilities operating at a marginal state of compliance, leaving room for potential lapses and deviations.

The US FDA, known for its stringent regulations, plays a pivotal role in ensuring the safety and efficacy of pharmaceutical products. It sets high-quality standards that serve as benchmarks for the global pharmaceutical industry. Given the interconnected nature of the industry, concerns with quality extend beyond national boundaries. Therefore, it is essential for Indian facilities, and indeed all pharmaceutical companies, to adhere to these standards to maintain global competitiveness and ensure the well-being of patients worldwide.

For more details, watch the accompanying video