The promise and perils of exhaled breath for early diagnosis and precision medicine

My lead story for the latest issue of science and technology magazine Shaastra is on the potential of exhaled breath in the early detection of killer diseases and to aid precision medicine. You can access it here.

I interviewed researchers from India, China, Israel and the US and was amazed at how far the science has come. Yet, more ground still needs to be covered. From the Indian perspective, with the country’s high disease burden in both infectious disease and NCDs, and the chronic under-investment in diagnosis and healthcare, exhaled breath could be liberating and gamechanging for both patient and provider. As an individual, it was refreshing to think of a future outside of what I like to call the ‘prick-prod-pee-poo’ modality.

Even as the story was being written, the first breath-based screening tests for COVID-19 were being deployed in Asia and Europe. Whether they prove their worth in real world settings or not, these are likely to yield important learnings for researchers and companies. As Hari Pulakkat, Editor, Shaastra writes in his letter, “there is another compelling reason why we believe this story merits your attention. It illustrates the recent change in the Indian science and technology landscape. More and more Indian researchers now work on contemporary problems, and diagnosis using breath is a case in point.” You can read more on why the magazine chose to lead the issue with this story here.

Start-up interest gives boost to development of #point-of-care solutions #medtech

The pandemic has underscored the need for rapid, accurate and affordable screening and diagnostic tools that are as close to the patient as possible. In the latest issue of Shaastra, I have profiled a clutch of companies that are using a wide range of technologies to come up with solutions. You can read the story here. India definitely needs local solutions. The traditional model of importing high-cost western technology has shown itself for what it is : an expensive, inefficient model that caters to a relatively small private market. Then, for a slew of tests, the mode of fulfillment – through well-capitalised, central/referral labs – also has its limitations as was amply demonstrated during the pandemic. RT-PCR testing for Covid-19 was marked by long wait times for testing and results, a shortage of trained staff and consumables thus constraining efforts to curb spread.

This story looks at companies trying to tackle both kinds of challenges – of the need for local solutions and of bridging the distance between the testing and the patient – at once, and for a range of diseases.. Diagnostics has been an area of under-investment for India but the worm is now turning. The question is how quickly and efficiently it does so.

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. Continue reading “Stent price control: 5 reasons why ‘high-end stent’ companies might still hope”

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 government would be forced to take steps as they have done to cap prices in the past for items like stents and orthopaedic implants,” reported the newspaper Mint quoting a person aware of the matter who spoke on condition of anonymity.

I asked, Rajiv Nath, President, AISNMA, the association of homegrown manufacturers that made this offer, in an e-mail : why wait for an NPPA ultimatum? If a cap was implementable, why not just go ahead and do it? I have published responses to these and other queries in their entirety in the interest of clarity. But before that, my take based on these responses and the media coverage on the issue. Continue reading “Is self-regulation in #medtech doomed to fail?”

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

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

#MedicalDevice pricing in India:”Don’t use a shotgun to kill an ant,”says industry veteran

Ajay PitreLate last month, the Maharastra Food & Drug Administration wrote to the National Pharmaceutical Pricing Authority (NPPA) to include medical devices in the Drug Prices Control Order (DPCO) which gives the NPPA its power to fix drug prices. Since the NPPA has been on overdrive, recently adding 108 drug formulations to the list of 348 already under price control, this sort of development can no longer be dismissed.

Medical devices are definitely a not-insignificant part of overall healthcare cost but should their prices be fixed by the government and should it be under the same set of rules as drugs? I spoke to Ajay Pitre to understand this issue better. Continue reading “#MedicalDevice pricing in India:”Don’t use a shotgun to kill an ant,”says industry veteran”

Sushrut’s sale to Smith & Nephew : what it says, and what it doesn’t

On May 2, UK-based trauma care products company Smith & Nephew said it would acquire Pune-based Sushrut Surgicals, a homegrown closely-held maker of orthopaedic implants such as bone plates and screws used to correct fractures and deformities, for an undisclosed sum, from the Pitre family.

The move took me by surprise. After all, Ajay Pitre, MD, Sushrut was the man who, six years ago, goaded me to write about India’s homegrown medical devices sector and its potential. Continue reading “Sushrut’s sale to Smith & Nephew : what it says, and what it doesn’t”

Medical technology in India: Is the worm turning?

Biosense's device represents rare product innovation in the Indian med tech sector
Pic sourced from http://www.biosense.in

A recent edition of TED Talks featured Myshkin Ingawale a co-founder of Mumbai-based Biosense which has invented a needle-free, handheld haemoglobin measuring device. This is big for a country where anaemia or low haemoglobin count is the leading cause of maternal mortality even though iron supplements are cheaply and plentifully available.

Many of these deaths can be averted with early diagnosis but women often lack adequate and timely access to healthcare facilities and don’t know they need iron supplements. Continue reading “Medical technology in India: Is the worm turning?”