The Compound Eye

Policy Focus

Nanopharmaceuticals to the Rescue: 

The Department of Biotechnology, Government of India in collaboration with Indian Society of Nanomedicine have released draft guidelines for evaluation of nanopharmaceuticals in India. The formation of the guidelines has involved members from AIIMS, CDSCO, THSTI, CDRI, DBT, DST, ICMR and many other organisations.  These guidelines provide the first set of rules intended to provide transparent, consistent and predictable regulatory pathways for nanopharmaceuticals in India. The use of nanopharmaceuticals particularly for improving targeted drug delivery would be valuable for Indian healthcare. These guidelines apply to the nanopharmaceuticals in the form of finished formulation as well as API of a new molecule or an already approved molecule with altered dimensions, properties or phenomenon associated with the application of nanotechnology intended to be used for diagnosis, treatment, mitigation or prevention of diseases in human. They do not apply to conventional drugs or medical devices or cell-based therapies involving nano-particles.

The major recommendation in the guidelines is to assess each application on its own merit of the data submitted using scientific judgement and logical argument. The guidelines recognize various types of nanoparticles on basis of degradability of nanomaterial, nature of nanomaterial, nanoform of the ingredient and approval status of the drug and nanomaterial. The guidelines lay the foundation for safety and efficacy studies, animal toxicology studies and clinical trial data requirements.

These guidelines are an excellent starting point, bringing clarity to a field where India lacked specific guidelines. The case-by-case approach brings flexibility in approving applications. However, similar to other guidelines, this document also distinguishes efficacy and safety studies as two different forms of interrogation. In addition to looking at maximum tolerated dose and minimum effective dose, a study design that investigates the ratio of efficacy and toxicity would be helpful in understanding relevant doses.

It's Controversial

Reawakening of the Brain

In a study published in Nature on 17th April, Vrselja et al describe an extracorporeal pulsatile-perfusion system that can support certain brain functions. The application of the system to brains of pigs led to preservation of cellular architecture, synaptic activity and active cerebral metabolism. The pigs being experimented on had been dead for 4 hours and the brains had been separated from the bodies. The study has raised questions in two broad areas:

The first area is philosophical: In the study, Electrophysiological monitoring did not detect any kind of neural activity thought to signal consciousness, such as any evidence of signalling between brain regions. The researchers deliberately prevented the pig brains from regaining consciousness, by using chemicals to block neurons from firing. But the results do raise questions of the origin and manifestation of consciousness in brains.

The second area is of a medical and bioethical nature. Brain-dead patients are usually kept on life support with familial consent. However, bioethicists and transplantation-policy researchers have had to wrestle with the question of when to switch from trying to save someone’s life to trying to save their organs for the benefit of another person. But with this study the possibility of new age technologies resuscitating a brain-dead person need to be also considered when making such decisions. An inclusive conversation is required between doctors, patient groups and bioethicists regarding emerging technologies and the ethical challenges they bring to our understanding of human biology.

Science in India

India's preprint repositories

India will soon host a preprint repository where authors from any discipline can post their manuscripts. The repository joins a growing number of preprint servers hosting research from a particular region, including Indonesia’s INA-Rxiv and Africa’s AfricArxiv.

The effort is being led by Sridhar Gutam who founded the Open Access India advocacy group. Authors can submit original research, case studies, conference proceedings and data sets in English or more importantly, any Indian language.

However several policies in India do not support preprint journals – any publications in these repositories are not recognised in government assessment criteria and many Indian journals do not accept articles already published in pre-print repositories. Consequently, an analysis of 69 Indian repositories found that a quarter received no uploads in the year leading up to June 2016. 

There are obvious advantages to pre-print repositories – a quick way to stake claim to an idea being the primary one. Worldwide, preprinting is gaining acceptance - The number of authors posting a preprint for the first time increased from 3,873 in 2014 to 84,339 in 2018. The total number of bioRxiv preprint authors rose from 4,012 to 106,231 over the same period. Two-thirds of the preprints posted on bioRxiv in or before 2016 were later published in peer-reviewed journals, most within six months of their initial posting to the site. Preprints that are downloaded more often on bioRxiv tend to be published in journals with higher impact factors than preprints that are not downloaded as much. Preprinting is a great platform for discussing ideas, getting peer reviews and communicating your work; particularly for those who may not be able to afford high publication charges.

With language no longer a barrier, let us hope that this preprint initiative facilitates discussion of science and scientific ideas throughout India.

Meanwhile, here is an ode to Star Wars

A New Hope: A new form of gene therapy - utilising HIV as a delivery vector – has brought hope to those suffering from SCID-X1, also known as the bubble boy disease. The gene therapy has been tested in 10 babies, with immune function having been restored in all of them. Another variant of gene therapy trialled a few years ago had resulted in leukemia in 2 out of the 10 participants. The babies that have received the therapy this time have not developed leukemia, but with only 25 months of monitoring period so far, we will have to wait for a long-term study to finish. For a quick conversation on the study and what it represents for gene therapies in India, do listen to this podcast from Takshashila Institution.

The Fabella Strikes Back: A tiny bone in the knee – the Fabella – which was thought to have been rapidly dwindling in humans is making a comeback. In monkeys the fabellae can act as a secondary knee cap, increasing the potential leverage and mechanical force, but it began to disappear in apes and early humans. The findings, published in the Journal of Anatomy come from over 21,000 scientific articles, detailing the physiology of 21,676 knees in in 21 countries over the past 150 years. It shows that in 1918, 11.2 per cent of the world’s population had fabellae, but today that has risen to 39 per cent – a 3.5-fold increase.

The authors speculate that it could be the shifting forces on the knee cap (read: better food, stronger muscles) that are behind its comeback. Interestingly, People with osteoarthritis of the knee are twice as likely to have a fabella, and its presence can interfere with joint operations, but it is not clear if the tiny bone is the cause – or a symptom – of joint problems.

The Return of the Horse: A frozen fossil of the Lena Horse has been found in the Siberian region of Yakutsk. The fossil is in excellent condition and efforts are on to possibly clone the animal. This is the first time liquid blood has been found in a fossil; however, since red blood cells do not carry DNA, they cannot be used as a template for the cloning process. But could we have a 42000 years old species running around us again and what would it unveil about a world gone by? Sci-fi alert! The days of a new force awakening may not be far away. 

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Shambhavi Naik Research Fellow
shambhavi@takshashila.org.in
080 4372 5304

Takshashila Institution

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