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Maharashtra FDA cancels licenses of 27 & suspends licenses of 94 units for non-compliance to D&C Act
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Shardul Nautiyal, Mumbai
February 17 , 2026
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In a major regulatory crackdown, the Maharashtra FDA has cancelled licenses of 27 and suspended licenses of 94 allopathic drug manufacturing units for non-compliance to Drugs & Cosmetics (D&C) Act across the state, according to official sources.
Besides this, 03 licenses of ayurvedic drug manufacturing units were cancelled and 14 were suspended. This is based on inspections done of 642 allopathic drug manufacturing units out of existing 896 units, and 140 ayurvedic drug manufacturing units out of 455 existing units during the period of April 1, 2025 to January 31, 2026.
“While the D&C Act mandates inspections every three years, the Maharashtra FDA has enhanced regulatory oversight to ensure compliance to Good Manufacturing Practices (GMPs) by inspecting all Allopathic and Ayurvedic drug manufacturing units in the state on an annual basis. These inspections have uncovered several violations, including cases of adulterated ayurvedic products containing allopathic ingredients,” according to an official.
Based on inspections of 4,589 drug retail stores and 1,039 wholesale licensees in the state during April 01, 2025 to January 31, 2026, it cancelled 231 and suspended 1497 retail licenses. Based on regulatory action, 80 wholesale licenses were cancelled and 188 suspended. There are a total 1, 12, 436 retail licensees and 33, 262 wholesale licensees in Maharashtra.
Cancelling a drug licence means the formal termination of the legal authority granted to an individual or entity (such as a pharmacist, chemist shop, wholesaler, or manufacturer) to manufacture, sell, stock, or distribute drugs. It is a regulatory action taken under the D&C Act, 1940, rendering the business operation illegal from the date of cancellation.
Suspending a drug licence means the temporary halting of all operations authorized by that license for a specific, predetermined number of days. During this period, the pharmacy, manufacturer, or distributor cannot legally sell, stock, or distribute medicines.
Action for non-compliance to D&C Act was also taken on blood banks with 04 cancellations and 31 suspensions based on inspections done of 285 blood banks out of the 393 existing blood banks during the same period.
“In order to ensure the quality of the blood, the Maharashtra FDA has also ensured that all 393 blood banks in the state have been inspected once in a year,” an official informed.
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