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Human Challenge Trial – Need, Benefits and Challenges

As Companies race to bring out a vaccine against the Covid-19, Experts are divided on whether the challenge model for vaccine trials should be put to use in the current pandemic. Many people have volunteered to take part in the Human Challenge Trials (HCTs) which involves intentionally infecting volunteers with the novel Coronavirus, in order to speed up the vaccination development. Initiatives like 1DaySooner have seen massive registration of people in many countries who had signed up for such trials voluntarily. Clinical trials are essential to test the safety and efficacy of new treatments in any population. Advocates of  HCT believe that such trials could save valuable time in developing vaccines like a Covid-19 vaccine, as researchers would not have to wait for participants to contract the infection under real-world conditions. A paper in The Journal of Infectious Diseases has proposed replacing Phase 3 with human challenge trials which may subtract many months from the licensure process, making efficacious vaccines available more quickly. However, human challenge studies are ethically sensitive and raise several controversial and unresolved issues in research ethics.

Rare Diseases in India and Policy

The Government of India has recently notified the National Health Policy for Rare Diseases allocating Rs 4 crore to the All India Institute of Medical Sciences (AIIMS) while approving an estimated Rs 25 crore for the year 2021-22 exclusively dedicated to rare diseases. Rare diseases cumulatively affect around 350 million people worldwide of which 70 million people are from India. There has always been concern regarding India’s policy towards rare diseases and its lack of commitment towards finding a solution to this problem which can be seen through the meagre budgetary allocations for the health sector, especially for rare diseases. The absence of a public policy for the research and development of Orphan drugs adds to the problem. The new policy may come as a relief to those who need it yet India has a long way to go concerning its efforts and policies towards dealing with this issue.

Stem Cells – Sources, Types, Applications, Concerns & Regulations

Stem cell research and its use in therapy are at the frontiers of biomedicine. It is being explored as a panacea for a wide range of diseases from tissue damages to serious conditions like neurodegenerative diseases and cancer. Most recently, it is being explored as a possible tool to treat patients with severe cases of COVID-19 in China. While it is a high potential tool, it also has its share of associated risks.

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