FDA cancels licences of three Cadila warehouses over Aciloc drugs with different salts under one name

The Food and Drug Administration (FDA) has taken stringent action against Cadila Pharmaceuticals Limited. It has cancelled the drug sale and distribution licences of the company's central distribution warehouses in Pune (Wadki), Thane and Nagpur. The action follows serious irregularities in the sale and supply of medicines with different salts under the brand name 'Aciloc'.

The FDA's inquiry found that some wholesalers in Pune city had ordered ranitidine-based 'Aciloc 150' and 'Aciloc 300'. They were instead sent famotidine-based 'Aciloc 150+' and 'Aciloc 300+'.

According to the FDA, the main ingredient of the drug, the salt, was changed merely by adding a '+' sign to the brand name. The FDA said this could have caused serious confusion about the medicine among doctors, chemists and patients. It has treated the supply of drugs with different salts under a single brand name as a serious irregularity.

The inquiry also found a packing irregularity. As per the rules, the pack should have contained 14 tablets, but a pack of 30 tablets was supplied. According to the FDA, such discrepancies in packing and labelling can confuse patients and drug sellers.

In addition, the inspection book was not available during the FDA's inquiry. Keeping proper records of storage and distribution of medicines is an important part of the regulatory system, so the absence of inspection-related documents also became a ground for the action.

After examining these matters, the FDA cancelled the sale and distribution licences of Cadila Pharmaceuticals' central distribution warehouses at Wadki in Pune city, in Thane city and in Nagpur. The action sends a clear message to drug companies and distributors that violations of rules on brand names, salts, packaging and distribution will be treated seriously.