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. (Read more)
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.(Read more)
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. (Read more)
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. (Read more)