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
India’s latest healthcare shame is a shoddily-conducted government sterilisation drive that proved fatal for 13 women in rural Chhattisgarh. The tale that unfolded in Bilaspur has more than its share of dystopic elements : unhygienic surgical instruments, tainted drugs and women reportedly herded like cattle (or lured like prey) onto the operating table, surgeries completed at alarming speed, and the women sent home with little or no post-operative care, only to fall sick. Or die.
In the media, the spotlight is on a range of pertinent issues such as medical negligence, corruption and the unfairness of letting women bear the entire burden of family planning.
What’s come out looking really worse for wear, though, is the public healthcare system. Once again. The drive was government-funded, was ostensibly working towards targets set by the government, and used drugs reportedly bought through the public procurement machinery. Continue reading
Just when I thought things were getting a bit dull, they go and do this.
A few weeks ago, I got a call from the Editor of Quartz India. Sruthijith was surprised (shocked?) that his go-to-drug for cold was actually withdrawn elsewhere for safety reasons. Could I explain why it was okay for Indians to consume medicines that other countries balked at?
Now drug safety as some of you might have noticed over the years, is a bit of a pet peeve with me. But after working myself up time and again over it, I began to feel a bit like a stuck record. Now I only keep my fingers crossed and pray. (No, an activist I most definitely am not). I almost visibly slumped when I heard what he wanted. But then I roused myself. Surely, this was an opportunity for many reasons. The most important : more people read Quartz India than they do Apothecurry. But seriously, it was great that a general news website was interested in carrying an explanatory piece on drug safety. And without any horrifying news trigger like deaths or disabilities. Just because it is an important issue.
So I tried. I was warned, in no uncertain terms, to keep it simple and easy to understand for a lay audience. Now, as Somerset Maugham pointed out “To write simply is as difficult as to be good.” To my rescue came the words of Fortune magazine writer Sheridan Prasso whose writing workshop I once attended. “Write so your mother-in-law can understand.”
The result is here. It is lengthy and my thanks to Sruthijith for sparing the cuts. Many of you are from the drug industry and so won’t find any surprises here. But perhaps you could share this with your moms or mothers-in-law. Don’t give me their feedback though. I am a coward and experience has taught me they are ruthless.