Elite Pharmaceuticals Inc (ELTP)

[sharkey1]

It's cheaper and faster to have clinical trials in India, smart move by Nasrat.

Another important factor that draws the attention of clinical trials industry towards India is cost competitiveness. The cost for conducting clinical trials in India is one tenth of the cost in the USA. With many pharmaceutical companies relocating or outsourcing the clinical trial processes to India, the research and development expenditure in pharmaceutical industry has witnessed an exponential increase. The timelines set by the regulatory bodies in India ensure the trial applications to be approved in a relatively shorter span of time. For instance, DCGI gives its first response or approval for conducting clinical trials within 45 days whereas for conducting a bioequivalence study it takes 28 working days. Approval of investigational new drug (IND) by any referral bodies or expert would take additional 12 to 14 weeks. Any discrepancies in the applications will be sent back for review and hence delays the process by another 45 days.

If the first trial doesn't work/pass, just tweek the formula and start over.