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 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.
The 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
The 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
Apothecurry 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
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
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
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