Market Authorization of Biological Products in India

Definition of Biological Products:

According to DBT, Biologic drugs or biologics (also called as biopharmaceuticals or recombinant therapeutics) refer broadly to substances produced by living cells used in the treatment, diagnosis or prevention of diseases [1].

List of Biological Products:

1.	Sera
2.	Solution of serum proteins intended for injection
3.	Vaccines for parenteral injections
5.	Antigen
6.	Antitoxins
7.	Neo-arsphenamine and analogous substances used for the specific treatment of infective diseases
8.	Insulin
9.	Pituitary (Posterior Lobe) Extract
10.	Adrenaline and Solutions of Salts of Adrenaline
11.	Antibiotics and preparations thereof in a form to be administered parenterally
12.	Any other preparation which is meant for parenteral administration as such or after being made up with a solvent or medium or any other sterile product and which- (a) requires to be stored in a refrigerator; or (b) does not require to be stored in a refrigerator;
13.	Ophthalmic preparations
14.	Bacteriophages