Table 2 Constraints affecting clinical trials and research
From: India-EU relations in health services: prospects and challenges
Problem | Features and Implications |
|---|---|
Standards and Accreditation | • Requirement to conform with client country guidelines often cumbersome • Accreditation of Indian labs required even if they conform to accepted global standards • Compliance costs of meeting documentation, audit, infrastructure, qualification, training requirements |
Norms for clinical trials | • Stringent requirements for informed consent, transparency, adherence to prescribed norms |
Data Protection | • India not perceived as data-secure • Data exclusivity contracts have to be signed • Detailed audits required • Costs of litigation |
Manpower mobility | • Problems in getting visas for technical persons sent by Indian CROs to clients in EU-- short duration, single entry |