Tinderbox : How a meningitis vaccine tender singed GSK, Sanofi in India #UHC

23 Jun

The Competition Commission of India (CCI) recently slapped a Rs 63.5 crore fine collectively on GlaxoSmithKline Pharmaceuticals (GSK) and Sanofi Pasteur for attempting to collude to share a Union Ministry of Health tender for a meningitis vaccine and inflate prices. Indian health authorities have been immunising Indians performing Hajj, or the annual pilgrimage to Mecca, against meningitis since 2002. The case, which dates back to 2011, appears to be a great lesson in how not to tender.

What should’ve been a straightforward process for a single product with the same three suppliers year after year, took on the appearance of a farce with the tender being floated thrice over, more than one lawsuit, a disgruntled local producer and two vilified multinationals protesting their innocence. And to top it all, the guilt or lack of it of the Union Ministry of Health appears still open to question. Continue reading

My take on online drug retail for Indian Express

9 Jun

A couple of weeks ago, I met senior executives from Bengaluru start-up PM Health & Life Care. The company is getting ready to fire off an online marketplace for prescription drugs that connects chemists to consumers. I was surprised with the timing; that they would choose to reach out when just a little before, the Maharashtra Food & Drugs Administration cracked down on Snapdeal for allowing vendors to sell drugs online. More on why they felt emboldened, later.

Intermediaries for online drug retail will have to shoulder a far greater responsibility for what passes through their channels than they would say, for clothes or shoes. Read why in this column that I wrote for Indian Express published today. And yet, given the far from well-governed nature of drug retail in the country – where drugs are routinely sold without prescription and laws flouted – the intermediary can only be as good as its partner on the ground. Continue reading

Guest column : Doctor ‘scarcity’ a crisis of numbers or leadership? #UHC

27 Apr

Dr Raman KumarA recent article in the Indian Express reported statistics from India’s National Health Mission to highlight what it called “a debilitating shortage” of health specialists in the country. In doing so, it only reaffirmed what several experts, committees, and policy wonks have said all along: India needs more doctors.

For the longest time, India’s healthcare problem has been defined as one of numbers. Doctor demand outstrips supply, we are told. The accent has been on creating supply (predominantly in the private sector) to address this perceived shortage. I use the word “perceived” because the problem does not lie in numbers alone. What India faces is a full-blown leadership crisis caused by the systematic undermining of primary care physicians and the disproportionate clout wielded by super specialists in medical regulation against the backdrop of a lacklustre public health system. 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

Here I go again. My column on fixed dose combos for the Indian Express #pharma #safety

8 Apr

The Indian Express edit page today carries a column I wrote on fixed dose combinations (FDCs) post the Lancet article. For the record, the Lancet shone the light on a plethora of FDCs of the diabetes drug metformin with others that, they believe, have no rationale to be on the market. I have used the FDCs issue as a springboard to comment on the larger state of drug regulation and call for its rehaul.

The Express is usually prompt in publishing my opinion pieces. This one, for some reason, they carried after several weeks of me having filed it. So those of you who are wondering why I chose to react to the Lancet article now, wonder no more.

If it sounds as if this piece of commentary would hold true in any year that is because, unfortunately for the Indian patient, some health issues never go out of fashion. Read on. The headline is a bit too dramatic for my taste but if that’s what it takes to grab eyeballs then so be it. I want to add here that I hope someone in New Delhi with the power to effect change is reading these pieces I do for the Express because they sure as hell aren’t reading my blog.

Unassuming billionaire : I profile Dilip Shanghvi for Outlook magazine

16 Mar

Dilip ShanghviThe media, it appears, cannot have enough of Dilip Shanghvi, the 60-year old founder and controlling stakeholder of Sun Pharmaceutical Industries. That’s not surprising if you consider that on March 4 he overtook Mukesh Ambani, the second-generation oil-to-telecoms tycoon and arguably India’s most influential businessman, to become the richest Indian.

Of course, just because Shanghvi went from number two to number one among wealthy Indians that day does not suddenly make him a new-improved version of himself nor does it throw up hitherto unknown facets of his personality (unless you go dig really deep and if you want to do that why wait for him to grow a shade wealthier, right?)

What it does, however, is generate curiosity. So when Outlook magazine reached out, my job was cut out for me. Here’s the link.  Alternatively, you can click here and here for the PDF documents of the story as it appeared in the magazine, since the web edition seems to be missing some stuff.

The headline is not mine – as far as I am concerned, this ‘Sun’ arrived a while ago.

As an aside, this is the second time I’ve been warned by a commissioning editor to keep it simple. Do not badger the unsuspecting reader with big drug names, I was told categorically. (Seriously, I must be a pretentious bore). So I haven’t. That does not mean Shanghvi’s Sun Pharma does not make them. Try saying levetiracetam five times over without tripping over your tongue. Why? Because that barely pronounceable drug is one the reasons he upstaged Ambani.

Pic source : Sun Pharma

This post was altered to include more links to the article

Thermometers, BP monitors and other vital stuff that India DOES NOT regulate #MedTech #safety

16 Feb

Dr Ravindra GhooiThe Indian medical devices sector has lately been in the news for the government’s decision to liberate foreign direct investment controls on it. There is also some movement on the regulatory front with a decision to set up government-recognised medical device testing laboratories in the country. Apothecurry’s guest columnist Dr Ravindra Ghooi revisits the one issue that needs immediate attention but for some reason continues unaddressed. The sector’s appallingly unregulated state. Read on.

Whether it is pacemakers, bone implants or cardiac stents, patient lives hinge on the safety and effective functioning of devices. It is assumed that like other governments, India has strict laws concerning the manufacture, quality and testing of these. It may therefore come as a shock to those unfamiliar with the Indian regulatory landscape that the government seemingly does not consider many of these devices important enough to regulate. Continue reading

India and drug #patents : The Ghost of #Glivec haunts #Sovaldi

11 Feb

Dr Kristina LybeckerApothecurry welcomes back guest columnist Dr Kristina Lybecker. Her latest column is an elegantly simple “where the rubber hits the road” exposition of the recent rejection of patents on US biopharma company Gilead’s Hepatitis C drug Sovaldi in India. Coincidentally, Gilead’s European patent on Sovaldi was challenged yesterday by charity Medicins du Monde marking yet another interesting turn of events in this breakthrough drug’s eventful life. Read on as Dr Lybecker explains how the Indian Patent Office’s decision rather than aiding clarity in the understanding of India’s patent rules has only muddied the waters. Continue reading

Apollo Hospitals’ takeover of Nova Specialty : what it means #indiahealth

19 Jan

Earlier this month, Apollo Health and Lifestyle Limited (AHLL), owned by the Chennai-based Apollo Hospitals group, acquired Nova Specialty Hospitals, a chain of short-stay surgery hospitals, from Nova Medical Centres. The deal piqued my interest for more than one reason. I spoke to Neeraj Garg, CEO, of AHLL, and Mahesh Reddy, co-founder and director of Nova Medical Centres about the deal. Here’s the takeaway. Continue reading

Will India’s new #FDI policy in #MedTech have the intended effect?

7 Jan

India has decided to liberate foreign direct investment (FDI) in the medical devices sector from the conditions imposed on its pharmaceutical cousins. This begs the question : to what end? To recap, from January 21, FDI in medical devices will qualify for automatic approval of up to 100 per cent. Notably, this is irrespective of how the FDI flows into the country – via new investments in manufacturing/research (‘greenfield’) or the buyout of existing assets (‘brownfield’). This is unlike the pharma sector where brownfield investment is conditional, not automatic. Until now, medical devices were bound by the same FDI rules as pharma.

A Press Information Bureau (PIB) release evinces the fond hope that the move will encourage FDI inflows into medical devices thereby strengthening the hand of a “huge pool of scientists and engineers” who have the “potential to take the medical device industry to a very high level.” It says rather dismissively that the “domestic capital market is not able to provide much needed investment in the sector.”

Uninformed observers can be forgiven for inferring that a misguided FDI policy was a key obstacle that stood between India’s medical device sector and greatness.

Not true. Continue reading

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