Indian drug discovery : an ecosystem. And green shoots.

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.

Is India Pharma turning to exports because of price control?

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?”

Why the government wants to cap trade margins on drugs and why it shouldn’t

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 “Why the government wants to cap trade margins on drugs and why it shouldn’t”

Guest column : The ‘sin’ that led to an #FDA inspection #pharma #quality

Ajit KamathYou 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 “Guest column : The ‘sin’ that led to an #FDA inspection #pharma #quality”

India #Pharma 2014 : A quick look back. Part Three #pricing #nppa

The holiday season approaches, so here’s a quick look at the year that was for Indian Pharma, before we disappear into a haze of year-end festivities. It’s a mixed bag (what year isn’t?) including stuff that could influence the way things work in the years ahead. For convenience, I’ve divided up what I think are key developments into posts rather than stick to any specific chronology of events. The first post was on the regulation of Indian manufacturing and the second on clinical trials and pharmacovigilance. This one is about drug pricing. Continue reading “India #Pharma 2014 : A quick look back. Part Three #pricing #nppa”

India #Pharma 2014 : A quick look back. Part Two #clinicaltrials #pharmacovigilance

The holiday season approaches, so here’s a quick look at the year that was for Indian Pharma, before we disappear into a haze of year-end festivities. It’s a mixed bag (what year isn’t?) including stuff that could influence the way things work in the years ahead. For convenience, I’ve divided up what I think are key developments into posts rather than stick to any specific chronology of events. The first post was on the regulation of Indian manufacturing. In this second post, I look at developments in the regulation of clinical trials. Continue reading “India #Pharma 2014 : A quick look back. Part Two #clinicaltrials #pharmacovigilance”

India #Pharma 2014 : A quick look back – Part One #quality

The holiday season approaches, so here’s a quick look at the year that was for Indian Pharma, before we disappear into a haze of year-end festivities. It’s a mixed bag (what year isn’t?) including stuff that could influence the way things work in the years ahead. For convenience, I’ve divided up what I think are key developments into posts rather than stick to any specific chronology of events. In the first post, I look at developments in the regulation of Indian manufacturing. Continue reading “India #Pharma 2014 : A quick look back – Part One #quality”

India’s logic-defying drug pricing moves : My column in Quartz India

Just when I thought things were getting a bit dull, they go and do this.

Indian #pharma policy : Missing the wood for the trees

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 “Indian #pharma policy : Missing the wood for the trees”

Stop tinkering with FDI norms : my column in the Indian Express

Today’s edition of the Indian Express has an edit piece that I have authored on why the government should stop repeatedly tinkering with India’s foreign direct investment (FDI) policy for pharmaceuticals.

In this piece I have argued that there is no connection between the availability of essential medicines and the FDI policy and that this repeated hullabaloo around foreign investment is taking away the focus from those factors that do, in fact, have an impact on essential medicines. Not to mention the blatant double standards that it displays towards foreign-owned companies. You can read the column hereContinue reading “Stop tinkering with FDI norms : my column in the Indian Express”