Index
Air (Prevention and Control of Pollution) Act (1981), 82
All India Council for Technical Education, 20
API See Active Pharmaceutical Ingredient
applied research, 2
Aspen, 75
Astra Zeneca, 40
Aurigene, 32
Bangalore Genei, 32
basic research, 2
Biocon-Pfizer agreement, 76
creating contracts, 69–80
agreement drafting, 72–3
outsourcing, 69–70
preliminary documentation, 70–2
specific considerations in different types of agreements, 73–9
India core competitive advantage in R&D, 17–27
active pharmaceutical ingredient and technology transfer, 41
analytical methods and characterisation, 35
business models for contract manufacturing organisations, 35–7
clinical trials, 39–40
clinical trials in India, 40–1
advantages, 40
disadvantages, 40–1
contract manufacturing organisations, 33–4
contract research services, 32–3
cooperation models for outsourced services, 4–8
drug product manufacturing, 35
drug substance manufacturing, 34
environmental, health and safety guidelines, 81–8
evolution in India, 1–16
India as emerging hub of R&D outsourcing, 4
Indian companies, 31–2
key issues involved, 8–14
modes, 29–43
organisational patterns in R&D outsourcing, 3
outsourcing, 1–2
process development, 35
product development and manufacture, 37–9
conventional technologies, 37
drug delivery technologies, 37–8
when to outsource development work, 38–9
R&D outsourcing in pharmaceutical industry, 3–4
buyer beware See caveat emptor
Capacity Building Programme, 62–5
biology research, 64
Clinicaltrials.gov, 65
(Amendment) Bill (2007), 64–5
IP protection and regulation, 63
protocol, 64
tax, 63–4
captive direct offshoring model, 6
Case Report Form, 19
caveat emptor, 100
Central Drug Authority Bill, 95
Central Government, 65
main functions, 61–2
Certificate of a Pharmaceutical Product, 93–4
Certificate of Origin, 93
certifications, 89–97
Certificate of a Pharmaceutical Product, 93–4
clinical trials, 94–6
Good Manufacturing Practices, 92–3
Indian regulatory framework, 91
international regulatory certifications, 96
manufacturing licence, 91–2
No-Objection Certificate and Certificate of Origin, 93
Chembiotek, 32
Chopra Committee, 46
clinical research organisations, 95
clinical trials, 94–6
mission, 65–6
vision, 66
Clinicaltrials.gov, 65
business models, 35–7
contract research and manufacturing sector, 20
agreement drafting, 72–3
general terms and conditions, 73
biopharma industry, 69–80
measuring of services, 78–9
accuracy, 78
cost, 79
transparency, 79
preliminary documentation, 70–2
confidentiality agreements, 70–1
Preferred Provider Agreement, 72
term sheet, 71–2
R&D outsourcing contracts, 73–5
data, information and rights ownership, 74
improvement/inventions, 74
know-how, 74
patents, 74
publication, 74
trademarks, 74–5
specific considerations in different types of agreements, 73–9
marketing agreements, 77–8
pharma products contract outsourcing manufacture, 75–7
serve level terms and document, 78
cost competitiveness, 18–20
CRAM sector See contract research and manufacturing sector
CRF See Case Report Form
CTRI See Clinical Trials Registry – India
Cytogenomics, 32
Dangerous Drugs Act (1930), 46
DBT See Department of Biotechnology
DCGI See Drug Controller General of India
Department of Science and Technology, 65
Department of Scientific and Industrial Research, 24–5
direct third party, 6
Directorate General of Health Services, 11–12
Drug Enquiry Committee, 46
drug product manufacturing, 35
drug substance manufacturing, 34
Drugs (Prices Control) Order (1955), 48
Drugs Act (1940), 46
Drugs and Cosmetics (Amendment) Bill (2007), 64
Drugs and Cosmetics Rules (1945), 47
Drugs and Cosmetics Rules (1948), 90
Drugs and Magic Remedies (Objectionable Advertisements) Act (1954) 48, 60
Drugs and Pharmaceuticals Research Program, 23
Drugs Price Control Order (1995), 61
due diligence, 99–106
areas, 101–3
contents of report, 105
process, 103–5
utilised sources, 100–1
ECB See External Commercial Borrowings
EHS Guidelines See Environmental, Health and Safety Guidelines
Eli-Lily, 40
employment laws, 13
Environment Protection Act (1986), 82
Biopharma outsourcing, 81–8
challenges faced by Indian companies in EHS compliance, 86–7
India and, 83–5
Essential Commodities Act (1955), 61
ETP See effluent treatment plants
Evotec, 6
External Commercial Borrowings, 9
FDI See Foreign Direct Investment
FERA See Foreign Exchange Regulation Act
Foreign Direct Investment, 8–9
Foreign Exchange Management (Borrowing or Lending in Foreign Exchange) Regulations, 9
Foreign Exchange Management (Permissible Capital Account Transactions) Regulations, 9
Foreign Exchange Regulation Act, 52
Form 28, 92
full disclosure, 105
Hazardous Wastes (Management and Handling) Rules (1989), 82
Hindustan Antibiotics, 52
Human Pharmacology Study, 95
ICMR See Indian Council of Medical Research
IDPL See Indian Drugs and Pharmaceuticals Ltd.
iGATE Clinical Research International, 31
Income Tax Act (1961), 100
biopharma outsourcing evolution, 1–16
challenges faced by Indian companies in EHS compliance, 86–7
core competitive advantage in R&D in biopharma sector, 17–27
cost competitiveness, 18–20
resources and skill, 20–2
role of the government, 22–5
emerging hub of R&D outsourcing in pharmaceutical industry, 4
Environmental, Health and Safety Guidelines and, 83–5
reasons attributed to success, 6–8
cost efficiency, 8
linguistic compatibility, 7
medical infrastructure, 7
product patent regime, 8
reduced time to market, 7
strong banking system, 8
vast and diversified patient pool, 7
regulatory frameworks for drugs, 10–12
Directorate General of Health Services, 11
Indian Council of Medical Research, 10–11
State Licensing Authority, 11–12
Indian Drugs and Pharmaceuticals Ltd., 52
Indian Patent Act (1978), 52
Capacity Building Program: recent development, 62–5
biology research, 64
Clinicaltrials.gov, 65
IP protection and regulation, 63
protocol, 64
tax, 63–4
Central Drugs Standard Control Organisation, 49
mission, 65
vision, 66
Department of Biotechnology, 49–50
historical perspective, 45–55
implications of changing, 57–68
central government main functions, 61–2
state governments responsibilities, 62
Indian Council for Medical Research, 48–9
Indian Society of Clinical Research, 67
National Pharmaceutical Pricing Authority, 50–1
overview of the industry, 51–4
Indian Research Fund Association, 48
Indian Society for Clinical Research, 67
indirect third party, 6
Industrial Disputes Act (1947), 13–14
infinitely flat organisation, 3
Information Technology Act (2000), 75
installation costs, 19
insurance, 77
Intellectual Property protection, 12
Intellectual Property Rights, 73–4
background rights, 74
foreground rights, 74
International Finance Corporation, 82
inverted organisation, 3
IPA See Indian Patent Act (1978)
IPR See Intellectual Property Rights
IRFA See Indian Research Fund Association
ISO 14001, 85
ISO 9001, 85
management representatives, 104
manpower costs, 19
manufacturing costs, 19
manufacturing licence, 91–2
Medicinal and Toilet Preparation (Excise Duties) Act (1955), 48
Medicines and Healthcare Products Regulatory Agency, 96
Medicines Control Council, 96
medium scale industries, 86
Metahelix, 32
MSI See medium scale industries
National Biotechnology Development Strategy, 50
National Biotechnology Regulatory Authority, 95–6
National Institute of Medical Statistics, 11
National Institute of Pharmaceutical Education and Research, 23–4
network rganisation, 3
New Drug Policy (1978), 52
Technology Leadership, 23
No-Objection Certificate, 93
Ociumum Biosolutions, 31
Official Gazette, 65
offshore outsourcing, 18
offshoring, 2
OHSAS 18001, 85
Organisation for Economic Cooperation and Development, 2
Organisation of Pharmaceutical Producers of India, 34
creating contracts in biopharma industry, 69–80
agreement drafting, 72–3
biopharma outsourcing, 69–70
preliminary documentation, 70–2
specific considerations in different types of agreements, 73–9
key issues involved, 8–14
applicable law and forum, 14
arbitration clauses and enforceability of award, 14
employment laws, 13
foreign investment framework, 8–9
impact of global crisis, 8
Intellectual Property protection, 12
regulatory framework for drugs in India, 10–12
taxation, 12
women’s employment rights, 14
Patents (Amendment) Act (2005), 54
PCI See Pharmacy Council of India
contract outsourcing manufacture, 75–7
assignment/sub-contracting, 76
confidentiality and data protection, 75
failure to supply, 77
financial or commercial terms, 76
insurance, 77
liability on recalls, 77
orders and forecasts, 76
out licensing of IP, 75
performance terms, 75–6
technology transfer, 75
terms of sale, 76–7
warranties and indemnities, 77
India as emerging hub of R&D outsourcing, 4
R&D outsourcing, 3–4
Pharmacy Council of India, 60
Pharmazones, 24–5
Phase I trial See Human Pharmacology Study
Phase II See Therapeutic Exploratory Study
Phase III See Therapeutic Confirmatory Study
Poisons Act (1919), 46
Preferred Provider Agreement, 72
process development, 2
product development, 2
project selection, 5
protocol, 64
R&D See Research and Development
Ranbaxy, 30
re-engineering, 2
Research and Development, 2–3
India as the emerging hub in pharmaceutical industry, 3
India core competitive advantage in biopharma sector, 17–27
organisational patterns, 3
pharmaceutical industry, 3–4
Research Support International, 6
RSIL See Research Support International
SB Pharmco Puerto Rico, 103
Schedule M, 92–3
Schedule Y, 94–5
Securities and Exchange Board Act (1992), 100
Securities and Exchange Board of India, 102
Securities and Exchange Board of India (Mutual Funds) Regulations (1996), 100
Securities Contract Regulation Act (1956), 100
due diligence, 99–106
areas, 101–3
contents of report, 105
process, 103–5
utilised sources, 100–1
small scale industries, 86
sourcing, 2
spider’s web organisation, 3
SSI See small scale industries
starburst organisation, 3
State Drug Controllers, 62
State Drugs Inspectors, 62
State Industrial Development Corporations, 86
Statement of Objects and Reasons of the Act of 1940, 46
strategic partnership, 5
subcontracting, 2
Suven Life Sciences, 31
Synchron, 31
Syngene, 32–3
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