Maharashtra FDA Acts Against 880 Pharmaceutical Units for Violations

The CSR Journal Magazine

The Maharashtra Food and Drug Administration (FDA) has taken measures against 880 pharmaceutical manufacturing and sales establishments, leading to the confiscation of illegal drugs and cosmetics valued at Rs 11.41 crore between June and August 2026. This crackdown is part of an intensified inspection initiative led by FDA Commissioner Tukaram Mundhe, aimed at ensuring regulatory compliance and food safety throughout the state.

In this latest three-month operation, FDA officials performed 2,902 inspections, which included 607 manufacturing sites and 2,295 sales outlets. The department subsequently instituted regulatory actions against 140 manufacturing units and 740 retail establishments. Notably, 677 licences were suspended, and 203 were cancelled, according to an official press release from the FDA.

The operation also featured 104 search-and-seizure actions, resulting in the registration of 20 First Information Reports (FIRs) and the arrest of 21 individuals connected to the illegal drug and cosmetic trade. The total value of the seized stock is lower than the Rs 13.64 crore worth of items confiscated during the previous financial year.

Violations Identified During Inspections

The FDA discovered various violations in the course of its inspections, which included the production of substandard and unauthorised medicines, deficiencies in quality-control processes, and record-keeping discrepancies. Additionally, inspectors observed that medicines were being sold without the oversight of registered pharmacists, which raises significant concerns regarding consumer safety.

Further investigations revealed that some establishments were dispensing medicines without bills, distributing controlled substances without necessary prescriptions, and mishandling expired medicines. Concerns were also raised regarding improper storage of temperature-sensitive products, like insulin and vaccines, which are critical for patient health.

Commitment to Regulatory Oversight

Tukaram Mundhe emphasised the FDA’s commitment to ensuring the availability of safe, quality, and regulated medicines to the public. The acceleration of the inspection process is intended to strengthen regulatory oversight at all levels, from manufacturing to retail distribution. He asserted that facilities adhering to established regulations would receive support, while those engaging in violations would face stringent repercussions.

Mundhe has also been instrumental in reforming the food safety system with numerous high-profile inspections of food establishments across Mumbai and beyond. His efforts have targeted various forms of food adulteration—ranging from milk and paneer to other products—resulting in multiple licence suspensions.

This comprehensive approach reflects the FDA’s ongoing dedication to public health and safety, ensuring that pharmaceutical and food entities comply with regulations intended to protect consumers across Maharashtra.

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