The Worry Over Combo Drugs

Among the recently banned drug combinations, certain ingredients had no proven advantage. So why were they permitted?

- Namita Kohli

On September 12, as news of a Supreme Court ban on over 300 combination drugs broke, a section of social media users went into a tizzy. For them, in an otherwise mindboggling list of 328 fixed drug combinations (FDC), one particular cocktail stood out. This concoction is more commonly sold under the brand name Saridon—the omnipresent headache pill, so popular that the makers even have a dedicated website for it.

For many, the connect to the brand went beyond its pain-relieving properties. The famous Saridon jingle, for instance, will still trigger memories of a bygone era. So how did a drug that people had been having for years, and was stocked in household first aid kits, suddenly become unsafe? Was it really harmful?

According to a 700-page report by a sub-committee appointed under the Drugs Technical Advisory Board, the combination of paracetamol, propyphenazone and caffeine, or, Saridon, was one among the 300-odd combinations for which the makers could offer no “convincing scientific/ clinical/ justification” for the indications that the drug claimed to address. The list also included several common antibiotics, painkillers, cough syrups, and even anti-diabetic combinations that were not effective.

In the case of Saridon, the problem, said experts, lies in propyphenazone that poses a risk of “adverse reactions such as skin rashes, erythema (skin redness), leukopenia (low count of white blood cells), asthma precipitation” among other serious conditions. Although uncommon, the experts examining these drugs concluded that these reactions can be “severe and potentially fatal”. “It is also why the ingredient has been withdrawn from other countries,” they wrote in the report. Piramal Enterprises Limited, manufacturers of Saridon, did not respond to the queries about the drug sent by THE WEEK.