Fast Track Procedure and Outcome of Novel Drugs During Pandemic– A Holistic Review
- Prof Rama Chandra Reddy
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Department of Biochemistry, Yogi Vemana University College, Kadapa-516005.
The mediocre time required for a drug from the laboratory to a patient will take a tenure of approximately 10 to 12 years. For this, pharmaceutical companies need skilled professionals to provide clearance for manufacturing cost-effective drugs without side effects, including in pandemic situations. Hence, considering the pandemic, approval clearance time (ACT) shall be reduced because of an emergency without compromising the quality and safety of the product. The emergency usage authorization plays a key role, and concern regulatory agencies will fasten the procedure without compromising the protection, identity, strength, transparency, and quality (SISPQ) of the novel product. In this view, to release the newly invented drug into the market, timelines will be reduced to avoid damage to human welfare. During the pandemic, research has taken place in a short time, and the formulated drug product reaches the required persons/patients to avoid mortality without compromising the stability of the drug. Immuno-bridging studies are required to prove the new drug’s efficacy in several aspects. Several firms work on novel drugs/vaccines, but the success rate is 0.8%. This is the first comparative review article on fast-track procedures and the approval of emergency drugs during pandemic situations.