Maharashtra Fda Restricts Disprin Sales

The commissioner, Food and Drugs Administration (FDA) of Maharashtra, is learnt to have issued orders to stockists restricting them from marketing Disprin tablets in the state.

The order comes in the wake of reports that Reckitt Benckiser, the manufacturer, is marketing paracetamol and aspirin-based formulations under the same brand name.

Reckitt Benckiser used to manufacture an aspirin-based formulation under the brand name Disprin, but later discontinued the product and started marketing a paracetamol-based formulation under the same brand name.

Subsequently, Reckitt Benckiser also introduced the original aspirin-based formulation under the same name, creating confusion in the market.

Legal experts have argued that marketing two entirely different formulations under the same brand name is against the prevailing laws of the land.

They pointed out that Reckitt Benckiser had launched Acetyl Salicylic Acid (Aspirin) under the brand name Disprin globally in 1948.

It was initially launched as a pain killer, but after researchers confirmed its utility in dilating blood vessels for heart patients, it was promoted as such.

The US Food and Drugs Administration department sought public opinion before approving it as a useful cardiovascular drug.

Further, research confirmed its utility in cerebro-vascular disorders and also in rheumatoid arthritis.

The US FDA thus approved the drug aspirin under the brand name Disprin with different labels having different colours and specifications for use in cardio-vascular, cerebro-vascular and rheumatoid diseases.

In India, the same company launched aspirin as Disprin, but recently changed the formulation to paracetamol.

The Maharashtra FDA has expressed surprise that the Drug Controller of neighbouring Karnataka, where the manufacturing unit of Reckitt Benckiser is based, is allowing the manufacture of different formulations under the same brand name.

Commissioner FDA, Maharashtra, Uttam Khobragade, confirmed that stockists have been asked to hold back stocks of Disprin until the matter is resolved.

He said he had also written to his counterparts in Karnataka and asked them to look into the issue.