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.

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?”

“Come into my parlour..” India’s strange #medtech pricing decisions

webCorrect me if I am wrong but I do believe that the Union Ministry of Health and Family Welfare just acknowledged that when prices of a product are fixed, manufacturers are discouraged from entering the market. And that competition brings down prices. Yes, you read that right, competition, and not price control. Continue reading ““Come into my parlour..” India’s strange #medtech pricing decisions”

Guest column : The UN High-Level Panel on #accesstomedicines is a wolf in sheep’s clothing

Dr Kristina LybeckerIn 2015, the United Nations Secretary-General Ban Ki-moon convened a High-Level Panel on Access to Medicines. Its charge was to recommend solutions to the fallaciously described “policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” Unfortunately, their starting point was misguided, and – not surprisingly – the resulting report is dangerous nonsense.  Continue reading “Guest column : The UN High-Level Panel on #accesstomedicines is a wolf in sheep’s clothing”

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 a clear-cut legal pathway for online pharmacies to follow, friction with regulators could not be ruled out. And that these uncertainties would adversely impact e-pharmacies’ ability to raise funds from investors.

At a recent event organised by the Indian Internet Pharmacy Association (IIPA), it became clear that all this and more had come to fruition.

What intrigued me is that the e-pharmacy’s enemy number one appears to be India’s foremost chemist association AIOCD. IIPA members allege that they have had to endure regulatory harassment triggered by complaints from AIOCD members. These complaints have led to police investigations, regulatory raids, and the cancellation of licences of chemist shops supplying Internet pharmacies culminating in the IIPA openly accusing AIOCD members of instigating the administration to launch unnecessary probes against them. And of pressuring those chemists who do supply e-pharmacies to back off. Continue reading “Why do chemists hate e-pharmacies so much?”

#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 a mix of experts and lay persons – are the gatekeepers of ethics within their institutions. Just as a strong EC can blow the whistle on unethical behaviour, a weak or careless one might inadvertently abet it. Continue reading “#Clinicaltrials : Are India’s Ethics Committees weak links in the chain?”

Guest column : How to leverage a global policy revival in traditional medicine

Ashwin NaikOn Friday, May 13, India committed close to a million dollars to help create a benchmark document for training and practice of Ayurveda, Yoga, Unani, Siddha and Homeopathic medicine. It is indeed a significant commitment and the reinforcement of ongoing efforts by the World Health Organisation (WHO) to promote traditional health systems strengthening around the world.

What started with the Delhi declaration in 2012-13, with a consortium of South-East Asian countries is now slowly growing into an international collaboration. The Indian government used a country-by-country approach to sign bilateral agreements, starting with information centres in Mexico, Nepal, Malaysia, Russia among others. Continue reading “Guest column : How to leverage a global policy revival in traditional medicine”

Hospital infection big problem in India: NABH #indiahealth #nosocomialinfections

Last week, the Indian Express published my column on the urgent need for hospitals – big and small – to follow infection control norms. Click here to read.

While researching the column, I spoke to officials at the National Board for Accreditation of Hospitals and Healthcare Providers (NABH) to understand how the issue might be addressed. While hospital-acquired/associated infections (HAIs) have been a concern for some years now, the spectre of drug resistance makes addressing their occurrence that much more of an imperative. For that, hospitals need to take infection control seriously.

NABH, as its name suggests, sets up and operates accreditation programmes around quality-of-care at Indian hospitals. One of the things that piqued my interest was Safe-I, a handholding programme for hospitals, that is focused on infection control. Since 2012, NABH runs this in partnership with the healthcare company Becton Dickinson. Safe-I hopes to eventually become a robust source of HAI data through a network of participating hospitals. Excerpts from an e-mail interaction with NABH CEO Dr K K Kalra. Continue reading “Hospital infection big problem in India: NABH #indiahealth #nosocomialinfections”

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

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