It’s been a while since I put those long-form writing skills to work, and whatever you may think about the result, I really enjoyed myself. A few weeks ago, Shaastra, a new science and technology magazine by IIT Madras published my piece on emerging new drug discovery start-ups in India in the May-June issue, their first. You can read the article here. When I began researching this article, I was more curious than hopeful. I had been among those who chronicled the audacious foray into completely new drugs of a clutch of publicly-listed Indian generic pharmaceuticals companies in the late nineties and early 2000s, the initial euphoria and subsequent disenchantment of the stock market, followed by a quieter but telling restructuring of some, if not all, of these efforts.
What I found now gives rise to some cautious optimism. Of course, we are nowhere close to the Indian government’s Pharma Vision 2020 of being among the world’s top five pharma innovation hubs or even a global leader in end-to-end drug discovery and development. It doesn’t even seem likely in the foreseeable future for Indian drug discovery. But what has changed over several years is firstly, the creation of an ecosystem – with elements such as avenues of seed funding and incubation – that was almost entirely absent when generics companies first ventured into drug discovery. This has ensured that, at least to start work, you don’t need deep pockets i.e. substantial upfront capital expenditure in labs and equipment. The result is discovery start-ups founded by professionals – scientists and engineers, including some who worked in the labs of generics companies – who would, otherwise, likely not have turned enterpreneurs in such a high-risk field in India.
Secondly, the emergence of a contract research industry – set up to cater to foreign innovators – is now available to these start-ups to tap into, for a fee. Thirdly, the world is their oyster – from development to funding and commercialisation, many of these companies are thinking global from the get-go. Some of them are adopting a hybrid model that straddles continents to monetize their assets better.
But they are still relatively small in number. And they continue to fight an uphill battle as described in the article. Funding continues to be a major challenge, and unsurprisingly, there are calls for generics companies to take a more active interest in partnering with them. But the important thing is that they exist. In doing so, and in their quest to keep moving their assets further into development, they are building skills and exploring new pathways of development and funding, thus keeping the door open for others to follow. India is not even close to leading in drug discovery like the US or parts of western Europe, but the pandemic has under-scored that the associated knowledge and skills are a must-have for the country. Every effort must be taken to build them.
The government appears to have prevailed in its bid to ban over 300 Fixed Dose Combinations (FDCs). But in the most inefficient way possible. It has let the problem get out of hand, then fought the industry in more than one court, constituted two different committees to weigh in on the issue and culminated with a relatively small, but valuable, number of drugs from its 2016 list still awaiting further study. In the interim, it has drawn global criticism for its lax attitude towards safety. Read my quick take published yesterday on money control here. The ban comes a decade after the first attempts made to tackle the issue by the then Drugs Controller General of India, and 6 years after a Parliamentary Standing Committee strongly criticised the office of the drugs regulator for jeopardising patient safety.
As the National Pharmaceutical Pricing Authority (NPPA) gets down to revisiting the prices of stents and discussing their makers’ grievances in February, here are five reasons why multinational stent companies selling relatively high-end products can still hope. Continue reading “Stent price control: 5 reasons why ‘high-end stent’ companies might still hope”
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 “Is self-regulation in #medtech doomed to fail?”
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 “My #pharma #GST story : A study in customer satisfaction”
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 “Is India Pharma turning to exports because of price control?”
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 “#FDCban : No consolation prizes being awarded here”
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 ““Come into my parlour..” India’s strange #medtech pricing decisions”
In 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 “Guest column : The UN High-Level Panel on #accesstomedicines is a wolf in sheep’s clothing”
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 did India remove cap on number of #clinicaltrials per investigator?”