ABSTRACT
There are over 300 novel biological vaccines and drugs that have been given approval for use around the world. Manufacturing, marketing, and usage of any biological substance is regulated in India under The Drugs and Cosmetics Act of 1940, The Drugs and Cosmetics Rules of 1945, and the Environment (Protection) Act of 1986. In India, the process of applying for approval of a biological method or granting a licence is well documented, and the applicant needs to provide a large amount of technical data. A characterisation of the biological aspects, as well as clinical, safety, and stability data, as well as risk management, is essential. The Central Drugs Standard Control Organisation requires a complete application in the form of Form 44, along with all of the required paperwork, to be completed before the approval process is permitted to start. In this chapter, the step-wise procedure for application for new drug approval is described.
