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. Continue reading
I’ve been quite vocal in my views about the ban on fixed dose combinations on Twitter. So here’s a selection of my key tweets (and some retweets) on the subject. Good way to get a quick summary of the subject while I hem and haw over a longer article (if it ever gets written). Latest tweets on top. Continue reading
The Indian Express edit page today carries a column I wrote on fixed dose combinations (FDCs) post the Lancet article. For the record, the Lancet shone the light on a plethora of FDCs of the diabetes drug metformin with others that, they believe, have no rationale to be on the market. I have used the FDCs issue as a springboard to comment on the larger state of drug regulation and call for its rehaul.
The Express is usually prompt in publishing my opinion pieces. This one, for some reason, they carried after several weeks of me having filed it. So those of you who are wondering why I chose to react to the Lancet article now, wonder no more.
If it sounds as if this piece of commentary would hold true in any year that is because, unfortunately for the Indian patient, some health issues never go out of fashion. Read on. The headline is a bit too dramatic for my taste but if that’s what it takes to grab eyeballs then so be it. I want to add here that I hope someone in New Delhi with the power to effect change is reading these pieces I do for the Express because they sure as hell aren’t reading my blog.
Come September 30, a new deadline that the Indian drugs regulator, Drugs Controller General of India, has set for state food and drug administrations to produce safety and efficacy data on scores of marketed fixed dose combinations – two or more molecules combined in specific ratios – from manufacturers, will lapse.
This is the latest effort by the DCGI to weed out a number of drug combos that, at best, have no scientific reason to exist and at worst, can cause harm. Will it work? Continue reading