Biologics are the medicinal or diagnostic products obtained from living organisms and intended for human consumption. These products include serums, vaccines, antitoxins, antigens, blood, blood components, gene therapy, and tissues. The Central Drugs Standard Control Organisation (CDSCO) is the Indian national regulatory authority. It is responsible for the manufacturing and import of biological products in India. CDSCO is involved in evaluating the safety, efficacy, and quality of all biologicals in India. The Department of Biotechnology (DBT) governs all biological development and pre-clinical studies. The government of India, DBT, and the Ministry of Science and Technology oversee the Review Committee on Genetic Manipulation (RCGM). Research and development activities, as well as the sharing of genetically modified cell banks, must be approved by the RCGM. The Drugs and Cosmetics Act of 1940 and its subsequent regulations, effective from 1945, also govern the production and import of biologicals. For a new drug to be approved, the applicant is required to file an application in Form 44, along with the prescribed fees and all relevant data as per Schedule Y of the Drugs and Cosmetics Rules. The fundamental principle of the regulations is to ensure high standards of healthcare by making available safe, effective, and quality biologicals to everyone. Additionally, it aims to support the pharmaceutical industry in a manner that enhances public health and benefits patients.
Panda et al. (2026) studied this question.