In addition to the safety / efficacy combination, drugs and vaccines must be tested to determine various other characteristics such as:
- Immunogenicity (the ability of the drug to produce an immune response in the body),
- Pharmacokinetics (how the drug moves in and out of the body, or how the body affects the drug)
- Pharmacodynamics (how the drug works in the body or how the drug affects the body)
- Side effects,
- Dosage amount,
- Type of ingestion, etc.
Indian law prescribes a strict process
These properties are determined at the end of a rigorous process that, under Indian law, consists of several steps and phases. The Indian regime for the testing and approval of drugs and vaccines is governed by the Drugs and Cosmetics Act of 1940; the drug and cosmetic rules, 1945; and the New Drugs and Clinical Trials Rules, 2019. The same laws, i.e. the Drugs Act, Drugs Rules, and Clinical Trials Rules, govern the manufacture, testing, approval, sale, storage, and marketing of pharmaceuticals and homeopathic medicines, Ayurvedic, unani medicines and cosmetic products.
When regulating medicinal products, the provisions of the Rules for Clinical Trials (Second Schedule) require that the proposed product be first characterized in a laboratory to determine its molecular structure and other physical properties. It is then subjected to pre-clinical or animal testing. Only after the results of the preclinical, ie animal experiments, have been checked and verified, approval for “clinical trials”, ie human trials, is granted by the Drugs Controller General of India.
The experiments on humans themselves are carried out in three phases, with each phase comprising a larger number of test persons, culminating in phase III experiments with large groups of people.