Maharashtra FDA enhances regulatory oversight

As Maharashtra continues to evolve as a pharmaceutical hub, the Maharashtra Food and Drug Administration (FDA) remains steadfast in its mission to ensure quality, efficacy, and safety of drugs through enhanced vigilance, infrastructure upgrades, and technological innovation, even in the face of manpower constraints.

- Shardul Nautiyal, Mumbai

Maharashtra houses a diverse pharmaceutical sector, including 900 allopathic manufacturers, 440 ayurvedic manufacturers and 408 cosmetic manufacturers.

In a major regulatory push, the Maharashtra FDA has enhanced regulatory oversight to ensure compliance to Good Manufacturing Practices (GMPs) by inspecting all allopathic, ayurvedic and cosmetic manufacturing units in the state on an annual basis.

It has also enhanced vigilance to track movement of spurious drugs and detect any such clandestine activity which is detrimental to public safety and health.

According to an official, “Show Cause Notices (SCNs) have been issued followed by suspensions and cancellations based on violations or non- compliances by the respective drug manufacturers. Besides this, Maharashtra FDA has inspected all public testing laboratories approved and licensed by the Maharashtra FDA. These public testing labs are equipped with highly advanced and sophisticated instruments to help those manufacturers which lack such facility to assess the drug quality effectively.”

The state regulator has also uncovered violations of the Drugs and Cosmetics (D&C) Act during routine inspections conducted between April 2024 and March 2025. There are 105,000 retail and 32,000 wholesale license holders in the state.

The official further added that in order to ensure the quality of the blood, the Maharashtra FDA has also ensured that all 392 blood banks in the state have been inspected once in a year. Notably, officials also detected a significant case of spurious drugs supplied to government hospital pharmacies, raising serious concerns about public health and safety.