Table 6 Domestic Constraints to India's Health Services Exports to the EU
From: India-EU relations in health services: prospects and challenges
Constraint | Features and Implications |
|---|---|
Accreditation and standards | • Absence of mutual recognition agreements with key markets, requiring Indian providers to undergo cumbersome certification and registration processes • Lack of recognition prevents Indian companies from drawing on overseas pool of medical manpower • Lack of standardization in medical and nursing training in India • No regulatory body in some areas (paramedics) • Authentication systems not perceived to be credible • Lack of international accreditation by most Indian healthcare establishments, preventing medical value travel, insurance portability, clinical trials outsourcing • Lack of registration, standardization and overseas recognition of alternative medicines and therapies • Lack of central laboratory accreditation that is recognized internationally (CAP) |
Legal and regulatory framework | • Bureaucracy and delays in approval process for clinical trials • Delays in clearance for drug and sample shipments for testing • Multiple clearances required by CROs for undertaking clinical trials (from multiple Ministries) • Ethics approval process cumbersome as multiple committees involved • Absence of legislation in certain areas (movement of drugs within India, lack of procedural controls on use of medical devices) • Poor enforcement of registration for clinical trials • Slow regulatory clearances for bioequivalence studies • Lack of clarity in guidelines for biotechnology products • Jurisdictional issues about dispute resolution as lack of credible and efficient legal system in India • Gaps between India's clinical trials legislation and that of EU countries (e.g., requirement for pharmaceutical person for issuing drugs in the EU, not in India) • Concerns over violation of ethics by Indian CROs |
Data protection | • Concerns over possible breach of data confidentiality after data submission to Indian regulatory body • Lack of strict firewalls for data leakage, guidelines on data exclusivity lacking, not strictly enforced |
Insurance and litigation | • Lack of insurance portability, public or private from EU (related to lack of recognition of Indian qualifications and establishments) • Malpractice liability issues: concerns over dispute resolution, jurisdiction, appropriate compensation • Absence of insurance in India in emerging areas: clinical trials requiring insurance abroad at high cost |
Other | • VAT and service tax charged on services of consultants monitoring clinical trials and reporting to client (export-oriented services usually exempt from service tax) • Delays in getting multiple entry visas for consultants monitoring clinical trials, short duration visas typical • Delays in bringing certain medical devices into India affecting medical device testing, research-related outsourcing |