Abstract

It is widely agreed that pharmaceutical R&D has entereda phase of crisis, characterized by diminishing returns,spiralling costs and the threat of generic competition.These challenges have prompted a global restructuring ofthe industry and a reassessment of its R&D operations. Thecontract research and manufacturing services (CRAMS)industry has played a pivotal role in partnering withpharma and biotech companies to provide chemistryservices and advance their drug candidates. CRAMSorganizations too have to adjust to the on-going R&Drestructuring in a context of fi erce global competition. Thistransformation has clearly highlighted the rise of IndianCRAMS organizations, which have emerged as leadersfor API manufacturing and the provision of more complexchemistry services. This article will highlight the mainfeatures of the Indian CRAMS sector in the current R&Dtransformational setting, with its promises and challenges.