ABSTRACT
Medical gases are those that are made, packaged, and intended for delivery to a patient in the context of anaesthesis, therapy, or diagnosis. Medical gases may also be referred to as therapeutic gases. Oxygen, helium, carbon dioxide, nitrous oxide, medical air, and nitrogen are officially classified as therapeutic gases. These gases are often administered to patients before surgery, during surgery, and after surgery. In the event of an emergency, however, they may be administered to patients at any point in the treatment. These gases are delivered either in a container that is leak-proof, colour-coded, and clearly labelled in accordance with the mandates of the regulatory authorities in each nation, or through a central line that is connected to every area of the hospital. Even with all of the restrictions and safety procedures that have been laid out by the regulatory authorities, there are still incidents of medical gas mix-ups that have even resulted in the deaths of patients. The life of the patient is in danger as a result of the error that was made if a gas is admixed with another, unwanted gas, despite the fact that it is not done intentionally. So, in the end, who is to blame for the mix-up? The regulatory authority, the manufacturer, the distributor, the physician, or the nurse? The point is that this is a rhetorical question, and it cannot be answered in any meaningful way. In India, the Drugs Controller General of India (DCGI) is the government official in charge of deciding whether or not to provide licences for particular classes of drugs. The Central Government, in the exercise of its powers under Sections 5 and 7 of the Rule, stated that the required regulations, namely the Gas Cylinder Rules, 2004, control the filling, ownership, transportation, and importation of such gases. These laws were referred to as the Gas Cylinder Rules. The majority of individuals who are involved in the filling, ownership, transportation, and importation of such gases are meant to be protected by these regulations. In the US, the Food and Drug Administration (FDA) regulates medical gas manufacture and quality control under Title 21 of the CFR. Sections 201(g)(1), 321(g), 503(b)(1)(A), and 353(b)(1)(A) regulate medical gas manufacture, whereas 501(a)(2)(B) and 351(a)(2)(B) prevent medical gas adulteration.
