India’s drug safety infrastructure faces stark challenges—ranging from regulatory fragmentation to limited testing capacity—that collectively place patient welfare at risk. The system spans central and state authorities, giving rise to inconsistent oversight and enforcement across regions. In states like Telangana—India's bulk drug production powerhouse—quality control lapses are exacerbated by a lone testing laboratory overwhelmed by demand, managing only half of the required sample capacity. 

Weak regulatory coordination has produced alarming real-world consequences—from substandard cough syrups triggering child fatalities abroad to over a third of inspected manufacturing units being shut due to non-compliance. Adverse effects reporting mechanisms also remain fragile; for instance, the Pharmacovigilance Programme, yet to see widespread adoption of ADR reporting across hospitals and clinics.

Building a future-ready, trusted system demands reform on multiple fronts: decentralizing and expanding lab networks, streamlining drug recalls via digitization, adopting central benchmarking indices, enabling third-party audits, and fortifying pharmacovigilance practices. A harmonized, transparent, and well-resourced regulatory framework is vital to reflect India’s growing role as both a global drug supplier and healthcare guardian.