State FDA Seizes Rs 19 Crore Medicine Stock, Cancels 288 Licences

FDA medicine seizure involving cartons of medicines during a pharmaceutical inspection

The state Food and Drug Administration increased inspections of medicine manufacturers and sellers nearly 4.6 times between June and September compared with the April-May period, leading to the seizure of medicine stock worth about Rs 19.11 crore and action against hundreds of establishments.

According to figures reported by Lokmat, the FDA conducted 4,256 inspections and initiated 1,144 regulatory actions during the four-month period. It also carried out 115 search and seizure operations, registered 33 cases and arrested 14 people.

The enforcement drive covered both manufacturing and sales establishments. In April and May, the FDA conducted 120 inspections of medicine manufacturing establishments and 347 inspections of sales establishments, taking the two-month total to 467. The monthly average during that period was 234 inspections.

Between June and September, inspections rose to 965 at manufacturing establishments and 3,291 at sales establishments, taking the total to 4,256. The monthly average increased to 1,064. Inspections of manufacturing establishments rose by about four times, while inspections of sales establishments increased by approximately 4.7 times, according to the reported figures.

Regulatory action also increased during the period. In April and May, the FDA took 71 actions against manufacturing establishments and 366 against sales establishments, for a combined total of 437. Between June and September, the number of actions reached 1,144. The department issued 1,402 notices, permanently cancelled 288 licences and suspended 856 licences during the four months.

The action included cases involving the possession and sale of medicines without licences. Of the reported enforcement actions, 43 were linked to unlicensed medicine stock and sales. The department also acted in 31 cases involving objectionable advertisements, 14 cases involving counterfeit medicines and cosmetics, and 10 cases involving incorrect branding of cosmetics.

Other cases covered alleged violations under laws governing narcotic and psychotropic substances, medical devices, similar brand names and product labelling. The reported figures listed nine actions under the law governing narcotic and psychotropic substances, three involving medical devices, three involving similar brand names and two involving labelling rules.

The figures indicate a concentrated regulatory effort across the pharmaceutical supply chain, from manufacturing units to retail establishments. Licence cancellations and suspensions affect whether establishments can legally continue operations, while seizures and criminal cases represent more serious enforcement measures under the applicable laws.

The reported data does not specify the individual establishments involved, the locations of the seizures, the names of the medicines or the final status of the 33 criminal cases. The next stage of the enforcement process will depend on investigations, legal proceedings and decisions by the relevant authorities.


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