Last Updated on April 23, 2025 by The Health Master
FDA Maharashtra
In a determined effort to uphold the integrity of the pharmaceutical supply chain and safeguard public health, the Food and Drug Administration Maharshtra (FDA Maharshtra) has taken decisive action against numerous medical stores in the Pune division.
Following rigorous inspections conducted between April 2024 and March 2025, the FDA Maharashtra has cancelled the licenses of 89 medical stores and suspended the licenses of a further 488.
The majority of these violations were attributed to breaches of the Drugs and Cosmetics Act of 1940.
Violations Uncovered Across many Districts
The extensive inspections covered the entirety of the Pune division, encompassing the districts of Pune, Solapur, Satara, Kolhapur, and Sangli.
Shockingly, officials revealed that over 70% of the medical stores found to be in violation were operating within the Pune district itself, highlighting a significant area of concern.
Breakdown of FDA Maharashtra Action
The stringent measures taken by the FDA Maharashtra targeted both wholesale and retail segments of the pharmaceutical industry.
Among the 89 medical stores that faced license cancellation, 22 were wholesalers and distributors, while the remaining 67 were retailers.
Similarly, of the 488 medical stores whose licenses were suspended, 56 were wholesalers and distributors, and a substantial 432 were retailers.
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Surprise Inspections
Girish Hukare, the Joint Commissioner of the FDA Maharashtra (Drug) for the Pune Division, emphasized the proactive approach taken by the department.
He stated that the inspections, which included unannounced surprise visits, were instrumental in identifying the widespread violations.
Serious violations
FDA Maharashtra officials disclosed that the penalized medical stores were found guilty of a range of serious offenses.
These included the fundamental violation of selling medicines without proper bills, failing to maintain legally required records, dispensing prescription drugs without valid prescriptions, and the critical lapse of not having a registered pharmacist present at the pharmacy.
Fair Process Followed Before Strict Action
A senior FDA Maharashtra officer assured that the actions taken were not arbitrary and followed a due process.
“We conducted regular and surprise inspections across all districts.”
“Strict action has been taken only after giving the medical stores a chance to explain their side.”
“The accused is given two chances to explain their side before the action is taken.”
“We aim to ensure the safe and legal sale and distribution of medicines,” the officer stated.
This highlights the FDA Maharashtra’s commitment to fairness while ensuring accountability.
Public Health Risks Led to License Cancellation
Hukare elaborated on the specific circumstances that warranted the severe penalty of license cancellation.
He emphasized the seriousness of instances where a qualified person was consistently unavailable at the store.
“The licenses were cancelled in the incident of unavailability of the pharmacist at the store.”
“This is serious, as dispensing the wrong medicines by an unqualified person can pose grave health hazards to the patients.”
Furthermore, he highlighted the alarming discovery of medical stores engaging in the illegal sale of habit-forming drugs, narcotic substances, and pregnancy termination kits without the necessary prescriptions and proper documentation.
Such practices pose significant threats to public health and safety, necessitating the strictest possible action.
Q. What was the primary reason for the FDA Maharashtra’s crackdown on medical stores in Pune?
A. The primary reason was the widespread violation of the Drugs and Cosmetics Act of 1940 by numerous medical stores in the Pune division.
Q. How many medical stores had their licenses cancelled and suspended?
A. The FDA Maharashtra cancelled the licenses of 89 medical stores and suspended the licenses of 488 others.
Q. Which districts were included in the FDA Maharashtra’s inspection?
A. The inspection covered the Pune division, including the districts of Pune, Solapur, Satara, Kolhapur, and Sangli.
Q. What were some of the key violations found by the FDA Maharashtra?
A. Key violations included selling medicines without bills, not maintaining records, selling drugs without prescriptions, and not having registered pharmacists at the shops
Q. What is the FDA Maharashtra‘s aim in taking this strict action?
A. The FDA Maharashtra aims to ensure the safe and legal sale and distribution of medicines and to protect public health from the risks associated with unregulated pharmaceutical practices.
Q. What happens when a medical store‘s license is cancelled?
A. When a medical store’s license is cancelled, they are no longer legally permitted to operate a pharmacy or engage in the sale and distribution of medicines.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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