Tackling the US FDA

Indian Pharma companies facing strictures from western regulatory authorities: 1. Ranbaxy 2. Sun pharma 3. Lupin

Matrix Laboratories

a) Hyderabad based pharma company b)Qualified supplier of HIV drugs to WHO

FDAsmartA new york based start up

Helps the pharma companies to meet FDA requirements

CEO-Mr. Ram J. Balani

What does FDA require ?Four Questions which it wants to be answered :

1. Is the Drug or Biological substance safe ?

2. Does the Drug or medical device do, what it says ?

3. Can somebody be held responsible for key decisions and actions ?

4. Are the Company’s results and conclusions believable ?

What is GMP ?

•It means Good Manufacturing Practices

•Needs to be fullfilled before getting approval

•GMP compliance is a continous process and not one time effort

•WHO pulled Matrix lab for liniency in GMP

Decisions by the FDA

•Announced to open offices in India and China

•Can Conduct Surprise inspection anytime

•Already opened a office in Delhi few months ago

FDAsmart Initiatives•Organises Variety of Training sessions to assist the efforts of drug companies

•Sessions arre based on the experience of the firms who have achieved FDA standards

•Online sessions for training of Students

•Saves the efforts and time of Trainers as well as Trainees

•Doesn’t disturbs the R&D and Manufacturing work going on in the factory.

Conclusion

FDAsmart has taken an initiative and is working very nicely on Improving the Quality of the companies who want to get FDA recognition. Whiich is very good for the Indian Pharma sector, Because Indian firms have enough funds, enough manpower, etc…. But it just needs Guidance.

Thank you Take care