The Maharashtra Food and Drug Administration has cancelled the drug sale and distribution licences of Cadila Pharmaceuticals Ltd’s distribution centres in Pune, Thane and Nagpur after finding that medicines with different active ingredients were marketed under similar brand names and that prescribed pack sizes were violated.
The action followed hearings conducted under directions from the Bombay High Court after complaints that wholesalers who ordered one medicine were supplied another. The FDA said its findings raised the risk of confusion among doctors, pharmacists and patients and could lead to the wrong medicine being dispensed.
The medicines at the centre of the action were sold under the Aciloc brand. According to the FDA, Aciloc 150 and Aciloc 300 were available with ranitidine at 150 mg and 300 mg respectively. Products carrying the same names with a “Plus” addition contained famotidine at 20 mg and 40 mg respectively.
The regulator said the investigation found that some wholesalers in the Pune division had ordered Aciloc 150 and Aciloc 300 containing ranitidine, but invoices showed that they were supplied versions containing famotidine instead. The FDA subsequently prohibited the stock in question from sale and distribution.
Inspections were conducted in July 2026 at Cadila’s warehouses in Wadki in Pune, Bhiwandi in Thane and Nimji in Kalmeshwar, Nagpur. The inspections also found that famotidine tablets, which the FDA said were required to be sold in packs of 14 under the Drugs and Cosmetics Rules, were distributed as Aciloc 150 in packs of 30 tablets and Aciloc 300 in packs of 20 tablets.
The Maharashtra FDA also recorded a regulatory development in Gujarat. Gujarat’s Food and Drug Control Administration had cancelled manufacturing permissions for famotidine 20 mg and 40 mg products on September 29, 2026, with retrospective effect from June 2, 2026. Maharashtra officials noted that Cadila had not brought this development to their notice during the show-cause notice and hearing process.
Cadila had earlier challenged the Maharashtra FDA’s action before the Bombay High Court. Following the court’s August 11, 2026 order, fresh show-cause notices were issued to the three distribution centres. The company was given 21 days to submit a written explanation and was subsequently granted personal hearings.
The licensing authorities said the company’s explanations and submissions were unsatisfactory before passing reasoned orders cancelling the licences. The FDA also cited other inspection lapses, including the non-availability of inspection books, failure to display a “Not for Sale” notice for expired medicines, the absence of a competent person and the issuance of sale invoices without the required signature.
The regulator said the action was intended to prevent confusion in the medicines supply chain and ensure compliance with drug safety and distribution requirements.
