Outsourcing Biopharma R&D to India

Probir Roy Chowdhury is Senior Associate of J. Sagar Associates, and is part of the firm's Technology Practice Group. He advises on Information Technology Law in areas including outsourcing, data protection, and e-commerce issues, and his transactional practice includes advice on venture capital fund structuring, transaction structuring, legal due diligence exercises, investment in the education sector, entry strategies and foreign exchange regulations. He writes on several technology-related subjects, and has contributed to the United Nations WSIS Summit project on Technology Surveillance as well as chapters in Advances in Biopharmaceutical Technology in India published by BioPlan Associates Inc. He is a regular contributor to the Computer Law Review International.

• AcknowledgementsAbout the authorChapter 1: Biopharma outsourcing in India: its evolutionAbstract:1.1 What is outsourcing?1.2 What is R&D?1.3 Organisational patterns in R&D outsourcing1.4 R&D outsourcing in the pharmaceutical industry1.5 India as the emerging hub of R&D outsourcing in the pharmaceutical industry1.6 Outsourcing models prevalent in India: cooperation models for outsourced services1.7 Key issues involved in outsourcingChapter 2: India’s core competitive advantage in R&D in the biopharma sector: the impetus for outsourcingAbstract:2.1 Introduction2.2 Cost competitiveness2.3 Resources and skill2.4 The role of the government2.5 ConclusionChapter 3: Different modes of outsourcing biopharma R&D to IndiaAbstract:3.1 Indian companies involved in outsourcing activities63.2 Contract research services3.3 Contract manufacturing organisations3.4 Drug substance manufacturing3.5 Drug product manufacturing3.6 Process development3.7 Analytical methods and characterisation3.8 Business models for contract manufacturing organisations3.9 Insights into outsourcing of product development and manufacture3.10 Clinical trials3.11 Advantages and disadvantages of doing clinical trials in India3.12 Active pharmaceutical ingredient and technology transfer3.13 Conclusions and implicationsChapter 4: The Indian regulatory environment: a historical perspectiveAbstract:4.1 Indian Council for Medical Research4.2 Central Drugs Standard Control Organisation4.3 Department of Biotechnology4.4 National Pharmaceutical Pricing Authority4.5 Overview of the industryChapter 5: Implications of the changing regulatory environment in IndiaAbstract:5.1 Introduction5.2 Capacity Building Programme: recent development55.3 Clinical Trials Registry – India115.4 The Indian Society for Clinical Research125.6 ConclusionChapter 6: Creating contracts for outsourcing in the biopharma industryAbstract:6.1 Biopharma outsourcing6.2 Preliminary documentation6.3 Drafting of the biopharma outsourcing agreement6.4 Specific considerations in different types of agreements6.5 ConclusionChapter 7: Environmental, health and safety guidelines and biopharma outsourcing: an Indian perspectiveAbstract:7.1 Introduction7.2 The environmental, health and safety guidelines7.3 EHS guidelines and India7.4 Challenges faced by Indian companies in EHS compliance7.5 ConclusionChapter 8: CertificationsAbstract:8.1 Introduction8.2 Certifications8.3 Manufacturing licence8.4 Good Manufacturing Practices8.5 No-Objection Certificate and Certificate of Origin8.6 Certificate of a Pharmaceutical Product8.7 Certifications for clinical trials8.8 International regulatory certifications8.9 ConclusionChapter 9: The need for due diligence of service providersAbstract:9.1 Introduction9.2 Sources utilised prior to due diligence9.3 Areas of due diligence9.4 Due diligence process9.5 Contents of the due diligence report69.6 ConclusionIndex