Saroglitazar /Synriam example : Why the heck we Indians want FDA approval?

Saroglitazar/Synriam example : Why the heck we Indians want FDA approval?

Indian Heart J. 2015 Jan-Feb; 67(1): 8–10.

Published online 2015 Mar 4. doi:  10.1016/j.ihj.2015.02.014

PMCID: PMC4382552

PMID: 25820041

From ‘Make in India’ to ‘Made in India’: The saroglitazar story

Sivasubramanian Ramakrishnan, MD, DM, FACC∗

 For instance, India has 74 US FDA-approved manufacturing units, highest in any country outside the US.2 Indian industries presence in the patented drugs club is nearly non-existent.

"In the limited literature available, saroglitazar has shown good efficacy and acceptable safety profile.6–8 In the double blind PRESS V and Press VI studies,11,12 saroglitazar has demonstrated excellent anti-glycemic and anti-lipid effects in patients with diabetic dyslipidemia as compared to placebo or Pioglitazone. Based on these evidences, saroglitazar is approved for clinical use in India. In this issue of IHJ, data on the post marketing surveillance of the use of saroglitazar 4 mg in 3133 diabetic dyslipidemic patients over a 3 months period is presented.7 There was 35.8% reduction in triglycerides, 16.4% reduction in LDL cholesterol, 19% reduction in total cholesterol and 23.4% reduction in non-HDL cholesterol. In addition, the use of saroglitazar showed an impressive 0.9% absolute reduction in HbA1c. Unlike the fibrates and niacin, the drug is well tolerated. No serious adverse events including edema and weight gain are reported; two common side effects known to occur with drugs having a similar mechanism of action. The better tolerability and absence of significant side effects could be due to the absence of thiazolidinedione (TZD) ring in saroglitazar molecule."

 Let us be innovative organized sincere and ethical. We can produce many more drug Gems Like Saroglitazar.

 Indian drug approval agency should start approving  all biosimilars produced by indian companies  after they are proved to be safe and  efficacious in Indian population.

New molecule development is also time consuming; saroglitazar was also discovered in 2001, but was approved for the treatment of Type II diabetes by the Drug Controller General of India only in June 2013. A failed RCT could create havoc for the finances of the company, but a positive trial could truly create the first ‘Indian global molecule’ and a true Indian multinational pharmaceutical company. Only then it can claim the status of ‘made in India’

Then FDA will come begging rather than the other way round

For example some Indian company could  do a clinical trial on oral sodium nitrate for  peripheral vascular disease