Index

A

active pharmaceutical ingredient (API), 1, 56
approval process, 26
association of persons (AOP), 51–2

C

Central Drug Authority Bill (CDA Bill), 38
clinical development, 8
clinical research, 1, 36
clinical trial management, 8
clinical trial phases, 13
Clinical Trial Registry – India (CTRI), 29–31
clinical trials, 2, 7, 12–14, 22
clinical trials liabilities, 37
compensation, 24, 32, 37
contract manufacturing, 1
contract manufacturing concerns, 38
contract manufacturing organizations (CMOs), 9
contract manufacturing outsourcing, 7
contract research and manufacturing services (CRAMS), 6–7, 82
contract research organizations (CRO), 11, 37
contract research outsourcing, 7

D

direct taxes, 42
business income, 42
capital gains, 44–5

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