The Dehi High Court has quashed the ban of over 300 fixed dose combinations (FDCs) announced by the Indian government in March this year. This has left health activists and other drug safety proponents sorely disappointed. The Union Ministry of Health’s decision to ban what it termed “irrational” drug combinations – drugs that either need not or should not be combined into a single formulation – counts as one of its most sweeping, and decisive actions on drug safety in recent memory. However, judging by news reports, it appears to have stumbled on procedural grounds – on mere technicalities.
It is in human nature to look for silver linings to clouds. Or at least, it is in mine. So I tweeted that at least many FDCs had gone off the market after this notification. Then, I reckoned to myself that perhaps doctors might now think twice before prescribing dodgy FDCs. And I am sure, there are others thinking, “Well, at least the government tried.” (Including the government itself).
But then, I stopped short and went back and mentally obliterated all the silver linings. For, when it comes to fighting for drug safety, you have to win.
One, it’s true that many FDCs have gone off the market. The most famous one is Pfizer’s Corex cough syrup in its current avatar. But what goes off, can come back. If not from the same marketer, then from someone else. The Indian pharma market knows no vacuum. If there is demand in some pocket somewhere, some small-time manufacturer will rise to fulfil it. And once the market is large enough, the big guys will waltz in. And without an outright ban, the law will be on their side.
Two, we still have no real idea whether the average Indian doctor has entirely understood the need for an FDC ban to begin with. The government announced – it did not communicate. In fact, it is likely that many doctors trust the medical representative of the pharmaceutical company more than they do the regulator. For unlike the latter, a rep is approachable, visible, and open to questioning. Also, there are doctors for whom the rep is the primary source of information. So, for all you know, the High Court decision will be seen as another instance of the judiciary coming down on executive high-handedness (hamfistedness?), and nothing more. Doctors also tend to go with their clinical experience (which is logical), and if they have not received any patient complaints – and joined the dots – then they will just, well, ‘Ct all’.
Three, the “at least they tried” argument. This is not high school elocution. When a government department meets the pharma industry head-on, it had better be prepared. It is not just safety at stake here, but also credibility. (Remember Maggi?) Besides, if you’re going to be spending the taxpayer’s money fighting the industry in court, the least you can do is be on rock solid ground procedurally. Which it does not appear to have done. Or at least, it could not convince the judge. To quote the newspaper Mint : “(Justice) Endlaw clarified that the verdict did not decide on the issue of the FDC drugs being risky to consumers. It only found that proper procedure had not been followed for imposing the ban.”
A government department stumbling on “proper procedure”? That’s like Amartya Sen failing a 12th grade Economics paper. You cannot say, “at least he tried.”
Four, “the consumer is more aware, now” argument. Let’s not even go there. The consumer is more paranoid now, for sure. But whether this will translate into actual change in consumption without the backing of the medical fraternity is doubtful.
So to sum up, this is a fight that the government needs to win on appeal. There are no consolation prizes here.