Popular cough syrups pulled off shelves after India bans 14 fixed dose drug combinations

While the advantage of fixed dose combinations is that it is easier to administer and makes the medicines more affordable, there can be irrational combinations. Hence, the combination drugs can not only result in misuse especially, say, for codeine based medicines which have narcotic properties but also build resistance to certain molecules present in the drug.

According to industry sources, a total of around Rs 500 crore worth of products have been impacted. Companies such as Abbott, the private arm, and Mankind have seen significant impact. Abbott’s Phensedyl cough linctus, expected to be Rs 50-60 crore brands, Mankind’s Codistar, a Rs 140 crore brand with 25 percent market share and pediatric syrup Teddykof, will all be impacted.

Glenmark’s Asocril C, generating Rs 19-20 crore of sales annually, has been impacted while Dr Reddy’s has indicated none of the Zedex brands are under the scanner and have not been promoting Dialex DC, which is on the list.

The reason the impact might be limited is because after the government banned 344 fixed dose combinations in March 2016, companies became wary of fixed dose combinations. More so, they were aware of the government’s thinking on the FDCs in question hence not only changed combinations in time but stopped marketing drugs that could be impacted.

Lastly, doctors have lauded the move as they believe while many of these combination drugs, though having been used for years, saw a sudden spurt in usage for children during and post COVID-19 with many of them available over the counter or easily accessible without a prescription. ​