ABSTRACT
Products generated from biotechnology can be generically categorised as GMO foods, biomolecules, and vaccines, among other things. The Drugs and Cosmetics Act of 1940 and the Environment (Protection) Act of 1986 are the two primary pieces of legislation that are responsible for regulating biotechnologically generated items. In 2004, the Council for Scientific and Industrial Research (CSIR) formed a committee that identified four different categories of goods according to the starting material and end products that are live microorganisms. Dr R A Mashelkar served as the committee's head. The final product, which is a living microorganism, is seen as possibly posing a risk, so a safety study must be conducted before it can be established. Data on the drug's safety, including studies on its pharmacodynamics, pharmacokinetics, and toxicokinetics, as well as its immunotoxicity, immunogenicity, reproductive performance, and developmental effects, must be submitted. In this chapter, we will discuss only the steps involved in the vaccination and GMO food approval processes, since we discussed biomolecules and biosimilars in the previous chapter.
