FDA Cancels Cadila Pharma Licences in Pune, Thane, Nagpur Over Drug Mix-Up and Pack-Size Violations

Pune, 8th October 2026: The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale and distribution licences of Cadila Pharmaceuticals Ltd’s distribution centres in Pune, Thane and Nagpur for allegedly marketing medicines containing different active ingredients under the same brand name and violating prescribed pack sizes.

The action was taken after hearings conducted in accordance with directions of the Bombay High Court following complaints that wholesalers who ordered one medicine were supplied another.

During its investigation, the FDA found that Cadila Pharmaceuticals had marketed medicines under the common brand name Aciloс despite the products containing different active ingredients. According to the FDA, Aciloc 150 and Aciloc 300 were available with ranitidine at 150 mg and 300 mg respectively, while products carrying the same names with a “Plus” addition contained famotidine at 20 mg and 40 mg respectively.

Officials said the change in the principal active ingredient while retaining a similar brand name could create confusion among doctors, pharmacists and patients and increase the risk of dispensing the wrong medicine.

In July 2026, the FDA inspected the company’s warehouses at Wadki in Pune, Bhiwandi in Thane and Nimji in Kalmeshwar, Nagpur. The stock of the medicines in question was subsequently prohibited from sale and distribution.

The FDA found that some wholesalers in the Pune division had placed orders for Aciloc 150 and Aciloc 300 containing ranitidine. However, examination of invoices showed that they were supplied Aciloc 150 and Aciloc 300 containing famotidine instead.

The regulator also found violations relating to pack sizes. Under the Drugs and Cosmetics Rules, famotidine tablets are required to be sold in a pack of 14 tablets. However, Aciloc 150 was found to be distributed in packs of 30 tablets and Aciloc 300 in packs of 20 tablets.

The FDA noted that Gujarat’s Food and Drug Control Administration had cancelled the manufacturing permissions for famotidine 20 mg and 40 mg products on September 29, 2026, with retrospective effect from June 2, 2026. The Maharashtra FDA also noted that this regulatory development had not been brought to its notice by the company during the show-cause notice and hearing process.

The company had earlier challenged the FDA 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, followed by personal hearings.

The licensing authorities found the company’s explanation and submissions during the hearings unsatisfactory and subsequently passed reasoned orders cancelling the licences.

The FDA also found other lapses during inspections, including non-availability of inspection books, failure to display a “Not for Sale” notice for expired medicines, absence of a competent person and issuance of sale invoices without the required signature.

The regulator said the action was taken to prevent confusion and ensure compliance with drug safety and distribution requirements.