MH FDA Implements INR 24.59 Cr Worth Strategy to Strengthen Drug Regulatory System

Commenced on May 1, 2017, this initiative undergoes reviews by the Union Health Ministry every two years. Scheduled for completion by March 31, 2025, the scheme symbolises a joint endeavour to enhance Maharashtra's drug regulatory capabilities.

In a decisive move, the Maharashtra Food and Drug Administration (FDA) has unveiled a strategy to strengthen its drug regulatory system. The initiative uses INR 24.59 Cr from the allocated INR 136 Cr Centrally Sponsored Scheme (CSS) fund until March 2024.

This initiative, set into motion on May 1, 2017, is under active review by the Union Health Ministry every two years. Slated to conclude on March 31, 2025, the scheme represents a collaborative effort to elevate Maharashtra's drug regulatory capabilities.

The CSS, featuring a 60:40 financial partnership between the Central and state governments, aims to enhance Maharashtra's drug regulatory infrastructure to meet international standards.

"Acknowledging the urgency of bolstering compliance, the Maharashtra FDA is undertaking significant strides in augmenting its manpower. Of the 200 sanctioned posts, only 82 drug inspectors are presently active, prompting concentrated efforts to rectify shortages, particularly in the Marathwada and Vidarbha regions," said Maharashtra FDA Commissioner Abhimanyu Kale.

Addressing the shortage of Assistant Commissioners is another key focus, with 28 out of 66 sanctioned posts vacant. This shortage is particularly concerning given the diverse array of manufacturing units in Maharashtra, including 940 allopathic, 466 ayurvedic, 24 homoeopathic, and 395 cosmetics manufacturing units.

To rectify the critical workforce deficit, the Maharashtra FDA is conducting a thorough review of the track records of FDA officials, reinstating those who faced suspensions for various reasons.

Additionally, in the battle against counterfeit medicinal products, the Maharashtra FDA Commissioner has revealed a comprehensive plan involving a major overhaul of the workforce and laboratories. This initiative aims to combat non-compliance with drug rules and curb the illegal sale of counterfeit drugs.

A significant highlight is the establishment of a state-of-the-art drug testing lab in Pune, designed for the timely analysis of drug samples across the state. Currently, Mumbai, Aurangabad, and Nagpur collectively test thousands of samples annually, with efforts directed at enhancing capacities for more efficient and rigorous testing.

The FDA's focus on upgrading laboratories and increasing its workforce underscores its commitment to fortifying the integrity of the pharmaceutical supply chain.

The strategic overhaul aligns with the broader goal of ensuring the safety, efficacy, and quality of drugs in Maharashtra, contributing to the overall health and well-being of its residents.