Major Pharmacy companies look at alternative destinations for sourcing patients for their global studies. Exploration on these lines guides pharmacy industry to take interest in the developing countries. Amongst developing countries, India stands out prominently due to its huge treatment-native patient's population, English speaking, ICH-GCP trained investigators & clinical professionals and stringent regulatory guidelines.
As the multinational drug companies in the United States and European Union look east to outsource research and clinical trial activities, countries such as India has gain proficiency and expertise in assisting them in drug discovery and development.
Pharmaceutical companies find it increasingly difficult these days to recruit enough patients to test the drugs coming out of their laboratories. On average, more than 4000 patients are required for the Food and Drug Administration to approve an experimental drug for marketing. Forever day a product is delayed in getting to market; one million dollars a day are lost in revenue in the U.S.
- Sizeable population of treatment-naïve patients
- Significant number of English-speaking highly skilled and trained physicians
- ICH GCP and US Food and Drug Administration standards compliant investigator, research coordinator and associates
- Improved regulatory environment (Notification of amended Schedule Y, publication of revised national guidelines for biomedical research, changes in rules doing away with phase lag. in clinical trials.)
- Presence of well-equipped and state-of-the-art healthcare institutions across the country
- Large hospitals with considerable patient load with facilities for undertaking trials
- Good communication networks and information technology capabilities
- Availability of certified/ accredited central laboratories
- High enrollment rates
- Good patient compliance/ retention
- Cost-savings
- Duty-free imports of drugs intended for use in trials
- Availability of infrastructure to manage other tasks involved in clinical trials: data entry, data management, analysis and report writing.
- Introduction of a new patent regime in pharmaceuticals respecting product patents (instead of just process patents)
