title: Toxicologic pathology in a multicultural world--India.
abstract: The global practice of drug development is expanding into many different continents and countries. India, in particular, is rapidly emerging as an economic force in this arena by offering ever-expanding opportunities for pharmaceutical market expansion as well as productive drug development partnerships. The key to the country's current socioeconomic success appears to be education, particularly the development of higher and professional education. Also, recent modifications to India's patent laws offer greater protections and incentives for international investment. Increasing numbers of competent contract research organizations create attractive opportunities for large Western pharmaceutical companies with a desire to gain access to burgeoning markets as well as mitigate the rising cost of drug development with less costly services. Well-trained veterinary pathologists are available, appropriate facilities are being constructed, and laboratory capabilities are expanding. Developing a productive partnership with a credible laboratory service in India, as with any new provider, requires due diligence and knowledgeable scrutiny of key elements of the work stream, such as facilities, education and training of laboratory personnel, Good Laboratory Practices, animal care, timelines, and data management. Ultimately and with appropriate management, mutually beneficial drug development partnerships are available in India.
authors.affiliation: Department of Pathology, Lilly Research Laboratories, Division of Eli Lilly and Company, Indianapolis, Indiana 46225, USA.
authors.forename: A Eric
authors.initials: AE
authors.lastname: Schultze
authors.forename: Vijayapal R
authors.initials: VR
authors.lastname: Reddy
authors.forename: Kevin B
authors.initials: KB
authors.lastname: Donnelly
authors.forename: Brian R
authors.initials: BR
authors.lastname: Berridge
mesh_terms: D000818:Animals; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000379:methods*; D004353:Drug Evaluation, Preclinical; D004345:Drug Industry; D017408:Guidelines as Topic; D007194:India; D007449:Investments; D059232:Laboratory Personnel; D010330:Patents as Topic; D010336:Pathology / Q000379:methods; D014116:Toxicology / Q000379:methods