Playing Cat And Mouse

The recent government notification to ban some 344 fixed dose combination (FDC) drug formulations and the reaction, including legal disputes, are nothing new to the Indian pharmaceutical industry. For a predominantly branded generic drug market, FDCs are inevitable. But since the rationality of these combination drugs has always been a debatable issue, the ban and the industry opposition to it has become a routine.

Several expert committees appointed by the Drug Controller General of India (DCGI) in the past have recommended controlling irrational drug combinations. But, no ban has lasted under pressure from industry.

This situation is unique to India, where sales growth of companies is closely connected to brand launches. A company can only launch as many single drug brands as the total number of molecules available in the market. So, once the single drug brands are matured, the companies have to depend on combination brands for new launches to keep their sales growing.

To put it simply, the market can have only so many brands of ibuprofen, atorvastatin, metformin, rabeprazole and nimesulide, among others, and once the sales of these single brands slow down, the companies combine them for fresh launches.

While FDCs are mainly a way to increase sales, these also often help companies in skipping drug price control order in India, where the National Pharmaceutical Pricing Authority announces the price control on specific molecules. So, combining multiple drugs can actually help evade the price ceiling.

Be that as it may, combination drug brands are flooding the market. The industry justifies FDCs by citing better patient comfort and compliance. The therapeutic rationality — whether such drugs still function as efficiently as in single dosage or if they react to each other to kill the potency or create good/bad effect in combination — often takes a backseat in the race to increase sales.

The regulatory officials are constantly trying to contain the deluge, but apparently, the industry knows how to get away. There was a similar situation in 2007 when the Drug Technical Advisory Board advised all drug makers to voluntarily withdraw some 1,100 FDC brands from the market. The then DCGI M. Venkateswarlu ordered a ban of these combinations using a special provision in the Drugs and Cosmetics Act. But the drug makers and their lobbies used their industry protection and injunction tactics to overcome the ban. It is the same game again. And we hope ethics will win at least this time.