#FDC ban fiasco: Regulatory weakness and business opportunism brew dangerous cocktail

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 …

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Stent price control: 5 reasons why ‘high-end stent’ companies might still hope

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. 'All stents made equal' argument reopened to debate? According to a Mint newspaper report, the NPPA  requested a …

Is self-regulation in #medtech doomed to fail?

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 …

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 …

#FDCban : No consolation prizes being awarded here

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 …

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

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 …

Why do chemists hate e-pharmacies so much?

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 …

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

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 …

The ban on fixed dose combinations : Quick take #FDCban

I've been quite vocal in my views about the ban on fixed dose combinations on Twitter. So here's a selection of my key tweets (and some retweets) on the subject. Good way to get a quick summary of the subject while I hem and haw over a longer article (if it ever gets written).  Latest …

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 …