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FDA Maharashtra: Overhauling the Drug Regulatory System

The FDA Maharashtra Commissioner has unveiled a comprehensive plan to curb the proliferation of counterfeit medicinal products.

The Health Master

December 19, 2023

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Food and Drugs Administration FDA Maharashtra — FDA Maharashtra

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Last Updated on January 20, 2024 by The Health Master

FDA Maharashtra

In a groundbreaking move, the FDA Maharashtra (Food and Drug Administration) has recently introduced a comprehensive overhaul strategy, allocating Rs. 24.59 crore from the Rs. 136 crore Central assistance scheme until March 2024.

This strategic initiative, part of a Centrally Sponsored Scheme (CSS) with a 60:40 financial partnership between the Central and state governments, aims to fortify the state’s drug regulatory infrastructure.

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Background

Understanding the gravity of the situation, the Union health ministry is actively reviewing the CSS every two years, which was set into motion on May 1, 2017.

This ambitious project, slated to conclude on March 31, 2025, represents a collaborative effort to elevate Maharashtra’s drug regulatory apparatus to international standards.

Addressing Manpower Shortages

Current Manpower Status: Acknowledging the urgency of bolstering compliance, FDA Maharashtra Commissioner Abhimanyu Kale highlights that of the 200 sanctioned posts, only 82 drug inspectors are presently active.

Geographical Disparities: Concentrated efforts are underway to rectify shortages, particularly in the Marathwada and Vidarbha regions, underscoring the need for a more evenly distributed workforce.

Assistant Commissioners Shortage: With 28 out of 66 sanctioned posts remaining vacant, addressing the shortage of Assistant Commissioners becomes imperative, especially given the diverse array of manufacturing units in Maharashtra.

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Strategies in Action

Review and Reinstatement: To address the manpower deficit, the FDA Maharashtra is conducting a thorough review of the track records of FDA officials, considering reinstating those who faced suspensions for various reasons.

Training and Skill Enhancement: Emphasis on training and skill enhancement programs to equip FDA officials with the necessary tools and knowledge.

Counteracting Counterfeits

Overview of the Plan: The FDA Maharashtra Commissioner has unveiled a comprehensive plan to curb the proliferation of counterfeit medicinal products.

Focus on Manpower and Laboratories: Major overhaul in manpower and laboratories is underway to combat non-compliance with drug rules and stem the illegal sales of counterfeit drugs.

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Drug Testing Lab in Pune

Lab Establishment: A notable highlight of the strategy is the establishment of a cutting-edge drug testing lab in Pune.

Timely Analysis: The lab is designed for the timely analysis of drug samples across the state, ensuring a more efficient and rigorous testing process.

Upgrading Laboratories for Enhanced Testing Capacities

Current Testing Efforts: Mumbai, Aurangabad, and Nagpur collectively test thousands of samples annually.

Enhancing Capacities: Efforts are directed at enhancing capacities for more efficient and rigorous testing, emphasizing the FDA’s commitment to fortify the integrity of the pharmaceutical supply chain.

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