 |
India's US $ 5.3 billion pharma market
is growing at the rate of 14% yoy |
|
Indian pharmaceutical industry meets
70% of country's demand of pharmaceuticals |
|
24,000 pharmaceutical companies flourishing
in India |
|
Exports are increasing
at the rate of 30% |
| Infrastructure |
|
Availability of infrastructure: hospitals
14,000; doctors 500,000; hospital beds 700,000 (85% urban);
medical colleges 162; medical graduates 17,000/year |
|
Availability of accredited central
laboratories |
|
Large geographical coverage - potential
for multi-patient recruitment at major cities across the country |
| Compliance
with international standard |
|
India follows the newly prepared guidelines
on GCP, which are based on the ICH, FDA, European and World
Health Organisation recommendations, and cover most of the important
aspects of GCP |
|
Investigators are well versed with
ICH/GCP guidelines |
|
Clinical research
associates and study monitors are trained in GCP and follow
standard operating procedures that are compliant with GCP, GLP
and ICH |
|
Ethics Committee members
are aware of and comply with GCP |
| Stable
regulatory environment |
|
Typical
timelines for regulatory approvals: EC approval 4-5 weeks; regulatory
approval 12-14 weeks; total 12-14 weeks |
| Authorities |
Ministry
of Health & Family Welfare
Central Drugs Standard Control
Organisation |
|
INDIA
