Contract Research and Manufacturing Services (CRAMS) in India
The Business, Legal, Regulatory and Tax Environment in the Pharmaceutical and Biotechnology Sectors
- Milind Antani
- Gowree Gokhale, Nishith Desai Associates, India
The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications.
Lawyers specializing in international contract law; Upper level managers at companies which outsource services, specifically to India; M&A specialists