Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection assessment, monitoring and prevention of adverse effects with pharmaceutical products. The latest news is the outbreak of coronavirus which has been declared as the global emergency, by WHO, as it could spread to countries with fragile health systems. The scientists from china isolated the virus but didn’t share the sample, but the virus genetic sequence has been made available to the international researchers. However, researchers from Melbourne has isolated the virus from the first diagnosed person with infection in Australia. Now, this sample has been shared to the research labs around the world (recommended by WHO) to develop the accurate diagnostic tests and vaccines. This infection can be treated in two ways: antivirals and antibody vaccines but the most reliable method (in aspect of time and efficacy) vaccines are more preferable. Many companies are ready and agreed to perform the trails and produce the medicines to forbid the virus becoming an endemic infection.
And according to the latest news as on 31 January 2020, a doctor from Tamil Nadu state claims that his knowledge in siddha and Ayurvedic medicines can help in curing the corona virus fever with the herbal extract which is used to treat dengue, multi-organ fever and acute liver fever.” “We want to tell the World Health Organization (WHO) and the Chinese government that our medicine is very effective in treating multi-organ failure in corona fever condition,” he said.
New rules for clinical trials and their effect:
India’s Ministry of Health and Family Welfare (MoHFW) has published the final version of New Drugs and Clinical Trials Rules, 2019. The new regulations cover provision for promoting clinical research as well as complex topics such as orphan drug, post-trial access, and pre and post-submission meeting. The new rules appear comprehensive, well-balanced, and likely to improve the ethical and quality standards of clinical trials in India, which will further benefit patients and industry.
These rules will help, to provide patients with earlier access to drugs and also speed up the trial process and encourage local drug development. Provision for accelerated product approval under some conditions, especially pre and post-submission meetings with authorities, may add increased predictability and confidence in the system.