Maiti Rituparna, M Raghavendra
Department of Pharmacology, Prathima Institute of Medical Sciences, Nagunur Road, Karimnagar-505417, Andhra Pradesh, India.
Pharmacol Res. 2007 Jul;56(1):1-10. doi: 10.1016/j.phrs.2007.02.004. Epub 2007 Feb 20.
The concept of outsourcing for the development and global studies on new drugs has become widely accepted in the pharmaceutical industry due to its cost and uncertainty. India is going to be the most preferred location for contract pharma research and development due to its huge treatment naïve population, human resources, technical skills, adoption/amendment/implementation of rules/laws by regulatory authorities, and changing economic environment. But still 'miles to go' to fulfill the pre-requisites to ensure India's success. In spite of all the pitfalls, the country is ambitious and optimist to attract multinational pharmaceutical companies to conduct their clinical trials in India.
由于成本和不确定性，新药研发与全球研究的外包概念在制药行业已被广泛接受。印度将成为合同制药研发最受青睐的地点，这得益于其庞大的未接受过治疗的人口、人力资源、技术技能、监管机构对规则/法律的采用/修订/实施，以及不断变化的经济环境。但要满足确保印度成功的先决条件仍“任重道远”。尽管存在种种问题，该国仍雄心勃勃且乐观地希望吸引跨国制药公司在印度开展临床试验。
