Clinical trials

A regulatory process of drug approval is very important in ensuring that new pharmaceutical products are safe, effective and produced without quality standards. In this review, the approval procedures in India, The US and Canada are compared. This also involves an organized evaluation that is supported by scientists. The three systems aim to safeguard the well-being of the masses by ensuring that medicines reach the patients only when they are well characterized, evidence based, and of the highest quality, irrespective of the system structure, documentation requirements, reviewing period and the regulatory authority roles. This comparative study outlines similarities and specific regulatory aspects to define Indian, U.S., and Canadian drug-approval process. Keywords: Drug approval process, Regulatory affairs, Pharmaceutical regulations, New drug approval, CDSCO, USFDA, Health Canada, Clinical trials, Regulatory authority, Drug safety and efficacy.

ABSTRACTHydroxychloroquine is used in the treatment of malaria due to its pharmacological activity and with minimal adverse effects. Hydroxychloroquine is used in treatment of the diseases like rheumatoid arthritis and lupus erythematosus. In some countries, it is also indicated in the prevention or treatment of malaria. It has been developed in the 1950s from chloroquine, an old anti-malarial drug. COVID-19 is a highly contagious disease, transmitted through respiratory droplets by affected person through sneezing, coughing, talking, which also spread by touching a contaminated surface or may object. The person infected with the disease shows flu-like symptoms such as fever, muscle pain, cough and sore throat in five to six days after infection, while some patients may remain asymptomatic carriers. The disease further develops severe pneumonia in the patients. The mortality rate is high in patients with underlying conditions and those aged 60 years and above. This review complies about the mechanism, precautions, toxicity, ongoing trials of hydroxychloroquine and their medicinal usage. Keywords: Chloroquine, Clinical trials, COVID-19, Hydroxychloroquine.