ELS Review of USFDA Site Inspections in India Reveals Strong Focus on Quality

A review of site inspection data by Executive Director of Excel Life Sciences, Dr. Saurendra Das, has revealed that Indian sites are passing muster with one of the world’s most stringent regulatory agencies. Over a 7 year period and more than 30 site inspections, investigative sites in India have not received a single, OAI – Official Action Initiated, which is the most significant and negative of findings the agency can levy following an inspection. ELS has been directly involved with 4 of the inspections. For additional highlights, see the included slide/image. To find out how Excel Life Sciences can help your sites perform better In India, please visit our website. 

Diabetic Nephropathy in India

- Total Cases Seen Per Month: 2,455

- Avg. Cases Seen Per Month: 175 

• Highest: 300

- Avg. New Cases Per Month: 26

- Age Distribution:

- 50 Years old and higher: 57%

- Younger than 50: 43%

- Percent with Hypertension: 49%  

Standard of Care

  

Drug	Dose
Ramipril	2.5 mg
Amlodipine	10 mg
Erythropoeitin	3000
ACE Inhibitors	5-20 mg
Ca2+ Acetate	667 mg
ARB	25-100 mg
Prednisone	1 mg/kg
Azathioprine	Variable
Ca2+ Channel Blocker	10 mg
β-Blocker	50 mg
PO4- Binders	667 mg