The Indian biopharma industry is a highly regulated one. Before the commencement of production of any product or the conduct of a clinical trial, several clearances and certifications must be obtained from the relevant authorities. This chapter discusses the certifications which must be obtained from the relevant regulatory authorities and the timelines associated with obtaining them. This chapter also discusses the collaborations between domestic and foreign regulatory authorities.


manufacturing licence

State Drug Controller

No-Objection Certificate (NOC)

Certificate of Origin (CO)

Food and Drug Administration (FDA)

Good Manufacturing Practice (GMP)

Certificate of Pharmaceutical Product (CoPP)

Independent ...

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