Is self-regulation in #medtech doomed to fail?

27 Dec

The offer by needle and syringe manufacturers to voluntarily cap trade margins at 75 per cent after meeting with the National Pharmaceutical Pricing Authority apparently validates the view that without the actionable threat of price control, the healthcare sector cannot be trusted to self-regulate.

“The NPPA advised manufacturers to consider regulating price themselves; otherwise, the government would be forced to take steps as they have done to cap prices in the past for items like stents and orthopaedic implants,” reported the newspaper Mint quoting a person aware of the matter who spoke on condition of anonymity.

I asked, Rajiv Nath, President, AISNMA, the association of homegrown manufacturers that made this offer, in an e-mail : why wait for an NPPA ultimatum? If a cap was implementable, why not just go ahead and do it? I have published responses to these and other queries in their entirety in the interest of clarity. But before that, my take based on these responses and the media coverage on the issue. Continue reading

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My #pharma #GST story : A study in customer satisfaction

4 Jul

I don’t usually get too personal in my blogposts but this, I had to write.  A month ago, my chemist suddenly stopped supplying my preferred brand of iron pills. Each time I asked, the reply would be, “Supply nahin aa raha hai.”

Now, I am very particular about my brand of iron for two reasons. One, not all salts of iron agree equally well with all women. The wrong salt can cause a digestive side-effect that I’d rather not go into. This is the reason why many women, in the past, would abandon their iron supplements – they couldn’t tolerate the side-effects. These days, there are several more options.This brand contained a salt that agreed beautifully with me. Two, it was effective. I could seriously make out the difference when I wasn’t taking it regularly. There were probably other brands of the same salt but as my doctor had prescribed this and it worked, I stuck to it religiously.

Given this background, and of course my own former profession, I decided to take matters into my own hands. I called the closely-held, probably small-to-mid-sized, drug company, based in Mumbai which owned the brand and asked to speak to the brand manager. Continue reading

Is India Pharma turning to exports because of price control?

29 May

The Financial Express published an infographic today that showed that the Indian pharma industry’s turnover from exports was up to 65.8 per cent in FY16 from 57.1 per cent in FY11. The newspaper was quick to lay this at the door of enhanced government price controls though the graphic itself proved no such thing. The government “needs to ponder” over whether this was proving helpful to consumers, it said.

While I’m no great fan of price control as a long-term, sustainable solution for the affordability problem, I felt this claim was not rooted in sufficient research or at least not based on this particular infographic that was being used to back it. You can say a lot of things about India’s price control regime, but if India Pharma is enamoured of exports, price controls are only marginally, if at all, responsible. Continue reading

#FDCban : No consolation prizes being awarded here

2 Dec

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

“Come into my parlour..” India’s strange #medtech pricing decisions

18 Oct

webCorrect 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

Guest column : The UN High-Level Panel on #accesstomedicines is a wolf in sheep’s clothing

3 Oct

Dr Kristina LybeckerIn 2015, the United Nations Secretary-General Ban Ki-moon convened a High-Level Panel on Access to Medicines. Its charge was to recommend solutions to the fallaciously described “policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” Unfortunately, their starting point was misguided, and – not surprisingly – the resulting report is dangerous nonsense.  Continue reading

Why did India remove cap on number of #clinicaltrials per investigator?

5 Aug

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

Why do chemists hate e-pharmacies so much?

23 Jun

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

Guest column : What’s up with Practo?

15 Jun

As a doctor , I was very hopeful when digital health start-ups entered India a few years ago. I am a big believer in Information Therapy, and I felt that these start-ups would use technology to help connect patients directly with doctors. They would remove the middleman and reduce information asymmetry, thus making it easier for patients to find a doctor who’s right for them.

This is one of the reasons I’ve been an angel investor in health start-ups, and have followed Practo closely, since it is the poster boy of a successful digital health start-up in India. I was optimistic that once they had raised so much money, they would be able to make a dramatic difference to the way medicine is practised in India. Unfortunately, it’s been a long time and I’m extremely unimpressed by what they accomplished so far. Continue reading

#Clinicaltrials : Are India’s Ethics Committees weak links in the chain?

7 Jun

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

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