List of abbreviations

AOP Association of Persons

API active pharmaceutical ingredient

CAGR compound annual growth rate

CDSCO Central Drug Standard Control Organization

CMO contract management organisation

CRO contract research organisation

DCGI Drugs Controller General of India

EMEA European Medicines Agency

FDA Food and Drug Administration

GCP Good Clinical Practice

ICH International Conference on Harmonisation

ICMR Indian Council of Medical Research

IEC institutional ethics committee

ITA Income Tax Act, 1961

MHRA Medicines and Healthcare products Regulatory Agency

PE Permanent Establishment

R&D research and development

SAE serious adverse event

SUSAR suspected unexpected serious adverse reaction

TP transfer pricing

WHO World Health Organization ...

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