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
India seems to be making slow but sure progress towards reversing its abysmal track record in pharmacovigilance – medical jargon for monitoring the safety of marketed medicines. The country has reported 33,702 adverse drug reactions (ADRs), side-effects arising from a host of marketed drugs, Continue reading
So here’s the thing. While I was waxing eloquent about how Januvia and Galvus were proof that India’s patent laws work, and of differential pricing blah, blah, blah I got a call that spun me around a bit..
A very senior drug safety expert based in New Delhi seemed rather disturbed by the popularity of these medicines. He felt it was alarming that two new drugs with a safety and efficacy track record that is still being established in clinical practice should be so well-received by the medical community. He also believed that in the absence of a pharmacovigilance system in India that keeps tabs on drug side-effects, doctors will know little about the side-effects that may surface once the drugs are widely-marketed.
For instance, he referred to the fact that the US FDA had reported receiving 88 reports of pancreatitis between October 2006 and February 2009 from Januvia users. (Merck dismissed any cause-effect relationship). He wanted to know whether the DCGI had reacted to this piece of information by requiring its marketer to inform doctors. I don’t know that it has. (Merck -called MSD Pharma in India – has probably reached out in order to quell any fears, though I haven’t checked).
Of course, he also admitted that this has been historically true with a number of new drugs in India.
In deferrence to his very valid concerns, I thought it is fit to make a quick note of them here, just after my previous post on the gliptins’ sucess.