Regulatory affairs play a significant role in the pharmaceutical industry, it is “the process of gathering, reviewing, and monitoring the existing regulatory environment and creating regulatory plans and gaining a competitive edge for securing regulatory approvals required more than just acquiring facts”. A medical device is a treatment instrument that "does not work on or in the human body in a way that is primarily intended by pharmacological, immunological, or metabolic mechanisms”. In other words, a medical device is essentially any medical product, not a medicine or biological product. By the Drugs and Cosmetics Act, Central Drugs Standard Control Organization (CDSCO) oversees approving drugs, conducting clinical trials, setting standards for drugs, monitoring the quality of drugs imported into the nation, and coordinating the efforts of state drug control organizations by offering professional advice to ensure uniformity in the application of the Drugs and Cosmetics Act. The US Food and Drug Administration (FDA), a single agency, oversees the regulation of a trillion dollars’ worth of goods, or about 25 cents of every dollar spent, including 80 percent of the food supply in the US, all medical devices, and prescription drugs, animal products, cosmetics, and even the production of tobacco products. The FDA's Center for Devices and Radiological Health regulates companies that produce, repackage, re-label, and/or import medical devices sold in the United States (CDRH). Also, CDRH is in charge of overseeing the regulation of lasers, x-ray machines, ultrasound equipment, microwave ovens, and color televisions, among other electronic gadgets that generate radiation for both medical and non-medical purposes. The IMDR, which was published in January 2017 and became effective in January 2018, was produced by the Medical Devices and Diagnostics Division of CDSCO and is a set of structured regulations for medical devices. In February 2020, the "Medical Devices (Amendment) Regulations, 2020" were established, and they became effective in April 2020. The 2020 amendment now includes a new clause called "registration of specific medical equipment."

Novel coronavirus disease caused by the SARS-CoV-19 virus enters the host cell through the S-spike protein by binding to ACE-2. In December 2019, an outbreak of coronavirus originated from Wuhan, China and by the end of 2020, it was recorded in almost every part of the world including Italy, Germany, Iran, Spain, and also United states. This led to a Pandemic which was declared by World Health Organization on 11th March 2020. SARS-CoV-19 causes mild to moderate illness which leads to acute respiratory syndrome, by causing infection in the nose, sinuses, or upper throat. It can also affect the upper or lower respiratory tract and has caused millions of cases and deaths. Many diagnostic tests have been authorized by the WHO including Direct and Indirect tests. Due to the increase in the number of covid 19 cases, many medications were introduced as per the demands like anti-malarial drugs, anti-viral drugs, antibiotics, anti-inflammatory drugs, steroids, biological agents, etc. The SARS-CoV-2 has a spike protein on its surface that aids in the virus's attachment to and entry into human cells. To attach to the protein of SARS-spike-CoV-2 and stop the virus from infecting human cells, many monoclonal antibodies like Casirivimab, imdevimab, Tocilizumab, Sarilumab, Itolizumab, Siltuximab have been created. As monoclonal antibodies prevent viruses from entering cells and continuing to proliferate, as well as lowering viral loads and lowering the frequency of hospital visits, they can be used as an alternative to conventional therapies. Hence monoclonal antibody treatment can be considered an effective alternative treatment for treating SARS-CoV-2.