Tag Archives: india pharma

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

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

11 Mar

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

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

17 Apr

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

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

19 Dec

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 Two #clinicaltrials #pharmacovigilance

18 Dec

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 One #quality

16 Dec

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

25 Sep

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

Indian #pharma policy : Missing the wood for the trees

22 Jul

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

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

4 Dec

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

India & drug pricing : Now, list of essential meds questioned

23 Oct

In continuation of the challenges arising from the roll-out of India’s new drug pricing policy, a question has now been raised on the current National List of Essential Medicines (NLEM) that specifies the universe of drugs under price control.

“Some may argue that the NLEM is not appropriately designed,” said Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals (DoP) which administers the policy, addressing CEOs and senior executives at the annual general meeting of industry body OPPI three weeks ago. Continue reading

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