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
Correct me if I am wrong but I do believe that the Union Ministry of Health and Family Welfare just acknowledged that when prices of a product are fixed, manufacturers are discouraged from entering the market. And that competition brings down prices. Yes, you read that right, competition, and not price control. 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 abnormally high margin that trade channels are believed to earn on a relatively small portion of the Indian pharmaceutical market has become the latest painpoint for the central government. The margins in question even cross 1000 per cent in some cases, according to a new report by a committee set up by the Department of Pharmaceuticals (DoP) in the Union Ministry of Chemicals and Fertilizers to investigate the matter.
The committee has now recommended capping trade margins on not just such meds which go by the moniker of ‘trade generics,’ but all drugs.
A cap on trade margins is not only difficult to implement but will do precious little to lower the price that the consumer pays. It might even lead to disputes and litigation between companies, trade, and the government. Besides, trade generics constitute not more than 15 per cent of the overall pharmaceutical market – and that is an outside estimate. Yet, this is being done in the name of the consumer. Continue reading
The Competition Commission of India (CCI) recently slapped a Rs 63.5 crore fine collectively on GlaxoSmithKline Pharmaceuticals (GSK) and Sanofi Pasteur for attempting to collude to share a Union Ministry of Health tender for a meningitis vaccine and inflate prices. Indian health authorities have been immunising Indians performing Hajj, or the annual pilgrimage to Mecca, against meningitis since 2002. The case, which dates back to 2011, appears to be a great lesson in how not to tender.
What should’ve been a straightforward process for a single product with the same three suppliers year after year, took on the appearance of a farce with the tender being floated thrice over, more than one lawsuit, a disgruntled local producer and two vilified multinationals protesting their innocence. And to top it all, the guilt or lack of it of the Union Ministry of Health appears still open to question. Continue reading
You can imagine the trepidation of a pharmaceutical company when the US Food & Drug Administration (FDA) comes calling. Given the demanding nature of inspections, recent enforcement actions and the public scrutiny that each warning letter is subjected to, even a battle-ready manufacturing site with the most stouthearted management can’t help but feel a ripple of nervous tension.
Now, consider the situation if the visit were wholly unexpected. Continue reading
The media, it appears, cannot have enough of Dilip Shanghvi, the 60-year old founder and controlling stakeholder of Sun Pharmaceutical Industries. That’s not surprising if you consider that on March 4 he overtook Mukesh Ambani, the second-generation oil-to-telecoms tycoon and arguably India’s most influential businessman, to become the richest Indian.
Of course, just because Shanghvi went from number two to number one among wealthy Indians that day does not suddenly make him a new-improved version of himself nor does it throw up hitherto unknown facets of his personality (unless you go dig really deep and if you want to do that why wait for him to grow a shade wealthier, right?)
What it does, however, is generate curiosity. So when Outlook magazine reached out, my job was cut out for me. Here’s the link. Alternatively, you can click here and here for the PDF documents of the story as it appeared in the magazine, since the web edition seems to be missing some stuff.
The headline is not mine – as far as I am concerned, this ‘Sun’ arrived a while ago.
As an aside, this is the second time I’ve been warned by a commissioning editor to keep it simple. Do not badger the unsuspecting reader with big drug names, I was told categorically. (Seriously, I must be a pretentious bore). So I haven’t. That does not mean Shanghvi’s Sun Pharma does not make them. Try saying levetiracetam five times over without tripping over your tongue. Why? Because that barely pronounceable drug is one the reasons he upstaged Ambani.
Pic source : Sun Pharma
This post was altered to include more links to the article
Apothecurry welcomes back guest columnist Dr Kristina Lybecker. Her latest column is an elegantly simple “where the rubber hits the road” exposition of the recent rejection of patents on US biopharma company Gilead’s Hepatitis C drug Sovaldi in India. Coincidentally, Gilead’s European patent on Sovaldi was challenged yesterday by charity Medicins du Monde marking yet another interesting turn of events in this breakthrough drug’s eventful life. Read on as Dr Lybecker explains how the Indian Patent Office’s decision rather than aiding clarity in the understanding of India’s patent rules has only muddied the waters. Continue reading
The latest round of price interventions imposed on the drug industry by India’s National Pharmaceutical Pricing Authority (NPPA) has the industry fulminating. Just when it was recovering from being all but snubbed in the Union Budget, it finds that the NPPA has quietly pulled the rug from under its feet leaving it sprawled on the floor.
After the initial shock, industry captains have probably dusted themselves off and regrouped to figure out if they can sue the NPPA to oblivion. In their position, I would. Continue reading