Exposing the dark side: The story behind the ban on 14 FDC drugs

What are FDC drugs? What are their risks?

An FDC is a cocktail of active ingredients used in a fixed ratio in a single pill or syrup. Such combinations can reduce the ‘pill burden’, improve adherence to therapy and bring down costs. Thousands of FDC drugs are available in India and have been sold for decades. Many FDCs are considered safe—for instance, in the treatment of tuberculosis or HIV. However, there are certain combinations that can be pharmacologically incompatible, have abuse potential and could lead to antibiotic resistance in the population. A drug that has both acidic and alkaline ingredients would be ineffective.

What are ‘irrational’ FDCs?

FDCs using a combination for the first time are deemed “new" drugs and, hence, require prior approval from the Drugs Controller General of India (DCGI) before being licensed by the state licensing authorities (SLAs). However, many FDCs were licensed by SLAs without prior approval of DCGI, leading to an influx of drugs with little evidence on safety and efficacy. In 2016, after a panel found many of these FDCs “irrational", the government banned 344 FDCs. However, this ban was stayed by the Delhi high court. The Centre then moved the Supreme Court against the stay order.

What happened after that?

The apex court referred the issue to the government’s expert body, the Drugs Technical Advisory Board, in an order in December 2017 for a fresh review. The apex court, however, kept 15 FDCs licensed prior to 1988 outside the purview of its order, but allowed the government to carry out an inquiry. In September 2018, the government banned the remaining 329 FDCs.

What’s behind the latest ban?

The ban on 14 FDCs (for instance, Nimesulide + Paracetamol dispersible tablets) licensed prior to 1988, was recommended by an expert committee constituted by the union government. Around 40-50 brands currently available in the market could be affected by the ban. These drugs are used for cough, fever, pain and common infections. Paediatricians have welcomed the move, calling many of these combinations harmful. But many want to ban Nimesulide for single dose use as well, citing risks to the liver.

Should we be cautious about cough syrups?

One of the most pervasive use of FDCs is in cough syrups. Many experts argue that the ingredients used in them often work against one another, nullifying the effect. The evidence that cough syrups reduce the natural course of cough is weak. The USFDA has warned against their use for children. However, expectorants which ease the release of mucus is okay to use. Even among adults, cough suppressants should not be used without prescriptions, for it can pose risks to those with lung problems.