In addition to the safety/efficacy combo, medicines and vaccines must be tested to determine various other characteristics such as
- immunogenicity (the ability of the medicine to provoke an immune response in the body),
- pharmacokinetics (the movement of the drug inside and then out of the body, or how the body affects the drug),
- pharmacodynamics (the exact mechanism of action of the drug within the body, or how the drug affects the body),
- side effects,
- dosage quantity,
- method of ingestion etc.
Indian Law Mandates a Rigorous Process of Trials
These characteristics are determined at the end of a rigorous process which consists of multiple steps and phases, in accordance with Indian law. The Indian regime for testing and approval of drugs and vaccines is governed by the Drugs and Cosmetics Act, 1940; the Drugs and Cosmetics Rules, 1945; and the New Drugs and Clinical Trials Rules, 2019. This same set of laws, i.e. the Drugs Act, the Drugs Rules and the Clinical Trial Rules govern the manufacturing,…