Article Title: Opinion | The importance of trials in stem cell drugs
This article talks about the importance of trials in stem cell drugs. There are self-styled clinics in India offering a range of untested and unproven stem cell drugs but they will now come under clinical trials to regulate stem cell-based products as drugs. The author welcomes the new amendments to the Drugs and Cosmetics Rules of India. This is a good step because at present only 1.4% of the world’s total clinical trials are carried out in India, despite the country having 17% of the population and 20% of the disease burden of the world. The positive outcome is that there are maybe around 300 self-styled clinics offering a range of untested and unproven stem cell drugs in India and now, they will have to first be backed by clinical trials to prove the safety and efficacy of the drugs.
The article further explains the history of stem cell research. Also, a pharmaceutical company needs to conduct a clinical trial and satisfy the regulatory body of the country concerned with the result in order to get permission to market a new drug. The article has explained the different phases of a clinical trial. The author has also touched upon the potential of stem cell drugs market in India. The conclusion is that with the help of this positive move safe and efficacious therapies will evolve more efficiently, and potentially unsafe and non-efficacious ones will vanish from the market. The desired ethical purpose would be served.
Words to learn from this Article:
Stumbling block: Obstacle
Overhaul: a thorough examination of machinery or a system, with repairs or changes made if necessary.
Efficacy: the ability to produce a desired or intended result.
Injunction: a judicial order restraining a person from beginning or continuing an action threatening or invading the legal right of another.
Placebo: it is a substance or treatment of no intended therapeutic value.
Nascent: just coming into existence and beginning to display signs of future potential.
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