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
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
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
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
Just when I thought things were getting a bit dull, they go and do this.
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
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 here. Continue reading
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
Come September 30, a new deadline that the Indian drugs regulator, Drugs Controller General of India, has set for state food and drug administrations to produce safety and efficacy data on scores of marketed fixed dose combinations – two or more molecules combined in specific ratios – from manufacturers, will lapse.
This is the latest effort by the DCGI to weed out a number of drug combos that, at best, have no scientific reason to exist and at worst, can cause harm. Will it work? Continue reading