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
The central government, through the office of the Indian drugs regulator, has done away with the cap on the number of clinical trials per investigator. This is after it was pointed out by clinical research stakeholders such as sponsors and investigators, that this could lead to under-utilisation of clinical trials infrastructure, and investigator expertise.
The decision is now left to the Ethics Committe (EC) of the institution where the trial is to be conducted as was recommended by the Expert Committee set up by the government under the late Ranjit Roy Chaudhury. This is clearly a great relief to those involved in the conduct of clinical trials.
But at the risk of sounding like a wet blanket, I have to say – this sounds suspiciously like one of those on-again, off-again decisions that pretty much leave you where you started off with, wondering what really was achieved. Continue reading
Last June, I wrote about the burgeoning online pharmacy business on this blog.
Taking off on a column that I had authored for the Indian Express, I pointed out that while India’s regulation of brick-and-mortar pharmacies (or chemist shops) has been slack, online pharmacies would be held to higher standards. That in the absence of a clear-cut legal pathway for online pharmacies to follow, friction with regulators could not be ruled out. And that these uncertainties would adversely impact e-pharmacies’ ability to raise funds from investors.
At a recent event organised by the Indian Internet Pharmacy Association (IIPA), it became clear that all this and more had come to fruition.
What intrigued me is that the e-pharmacy’s enemy number one appears to be India’s foremost chemist association AIOCD. IIPA members allege that they have had to endure regulatory harassment triggered by complaints from AIOCD members. These complaints have led to police investigations, regulatory raids, and the cancellation of licences of chemist shops supplying Internet pharmacies culminating in the IIPA openly accusing AIOCD members of instigating the administration to launch unnecessary probes against them. And of pressuring those chemists who do supply e-pharmacies to back off. Continue reading
Clinical trials, that hot-button subject hogging headlines up until a year ago, appears to have quietly slipped into the realm of business-as-usual. However, there are still some knotty issues to be resolved. Chief among them is the oversight of Ethics Committees (ECs) as was evident at a recent event I attended.
ECs – which are a mix of experts and lay persons – are the gatekeepers of ethics within their institutions. Just as a strong EC can blow the whistle on unethical behaviour, a weak or careless one might inadvertently abet it. 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
Last week, the Indian Express published my column on the urgent need for hospitals – big and small – to follow infection control norms. Click here to read.
While researching the column, I spoke to officials at the National Board for Accreditation of Hospitals and Healthcare Providers (NABH) to understand how the issue might be addressed. While hospital-acquired/associated infections (HAIs) have been a concern for some years now, the spectre of drug resistance makes addressing their occurrence that much more of an imperative. For that, hospitals need to take infection control seriously.
NABH, as its name suggests, sets up and operates accreditation programmes around quality-of-care at Indian hospitals. One of the things that piqued my interest was Safe-I, a handholding programme for hospitals, that is focused on infection control. Since 2012, NABH runs this in partnership with the healthcare company Becton Dickinson. Safe-I hopes to eventually become a robust source of HAI data through a network of participating hospitals. Excerpts from an e-mail interaction with NABH CEO Dr K K Kalra. 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
A recent article in the Indian Express reported statistics from India’s National Health Mission to highlight what it called “a debilitating shortage” of health specialists in the country. In doing so, it only reaffirmed what several experts, committees, and policy wonks have said all along: India needs more doctors.
For the longest time, India’s healthcare problem has been defined as one of numbers. Doctor demand outstrips supply, we are told. The accent has been on creating supply (predominantly in the private sector) to address this perceived shortage. I use the word “perceived” because the problem does not lie in numbers alone. What India faces is a full-blown leadership crisis caused by the systematic undermining of primary care physicians and the disproportionate clout wielded by super specialists in medical regulation against the backdrop of a lacklustre public health system. 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