Tackling The Us Fda


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Tackling The Us Fda

  1. 1. Tackling the US FDA<br />
  2. 2. Indian Pharma companies facing strictures from western regulatory authorities: 1. Ranbaxy 2. Sun pharma 3. Lupin<br />
  3. 3. Matrix Laboratoriesa) Hyderabad based pharma companyb)Qualified supplier of HIV drugs to WHO<br />
  4. 4. FDAsmart<br />A new york based start up<br />Helps the pharma companies to meet FDA requirements<br />CEO-Mr. Ram J. Balani<br />
  5. 5. What does FDA require ?<br />Four Questions which it wants to be answered :<br />1. Is the Drug or Biological substance safe ?<br />2. Does the Drug or medical device do, what it says ?<br />3. Can somebody be held responsible for key decisions and actions ?<br />4. Are the Company’s results and conclusions believable ?<br />
  6. 6. What is GMP ? <br /><ul><li>It means Good Manufacturing Practices
  7. 7. Needs to be fullfilled before getting approval
  8. 8. GMP compliance is a continous process and not one time effort
  9. 9. WHO pulled Matrix lab for liniency in GMP</li></li></ul><li>Decisions by the FDA<br /><ul><li>Announced to open offices in India and China
  10. 10. Can Conduct Surprise inspection anytime
  11. 11. Already opened a office in Delhi few months ago</li></li></ul><li>FDAsmart Initiatives<br /><ul><li>Organises Variety of Training sessions to assist the efforts of drug companies
  12. 12. Sessions arre based on the experience of the firms who have achieved FDA standards
  13. 13. Online sessions for training of Students
  14. 14. Saves the efforts and time of Trainers as well as Trainees
  15. 15. Doesn’t disturbs the R&D and Manufacturing work going on in the factory.</li></li></ul><li>Conclusion<br />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.<br />
  16. 16. Thank you Take care <br />