Cover image for Contract research and manufacturing services (CRAMS) in India : the business, legal, regulatory and tax environment in the pharmaceutical and biotechnology sectors
Title:
Contract research and manufacturing services (CRAMS) in India : the business, legal, regulatory and tax environment in the pharmaceutical and biotechnology sectors
Personal Author:
Series:
Woodhead publishing series in biomedicine ; no. 19
Publication Information:
Philadelphia, PA : Woodhead Pub., 2012
Physical Description:
xx, 229 p. ; 24 cm.
ISBN:
9781907568190
General Note:
Includes index
Added Author:

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30000010298443 HD9672.I52 A58 2012 Open Access Book Book
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Summary

Summary

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.


Author Notes

Milind Antani is head of the international Pharma and Life Sciences practice at Nishith Desai Associates, and represents clients in matters including corporate mergers and acquisitions, regulatory and transactional matters, intellectual property prosecution and litigation, joint ventures and formation of new companies.

Gowree Gokhale is a partner at Nishith Desai Associates.