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Exports And Clinical Trials
For Medical Devices

  1. Definition of Medical Device

  2. Classifying Devices

  3. Current Technologies

  4. Industry Segments

  5. Global Clinical Trials

  6. Costs Macro and Micro View

  7. Regulatory Aspects

  8. DCGI Role

  9. Approval Timelines

  1. Checklist of documents for seeking permission to conduct Clinical Trial with Medical Devices under Drug category (With Drug / Without Drug) and Device category

  2. Checklist of documents to be submitted for Export License
  3. Current Trials being Conducted in India – NIH Registered
  4. Global Trials in India
  5. Why India ?
  6. Interventional Cardiology Device based Trials
  7. Issues in India
  8. Future of Medical Devices
  9. New Product Areas
  10. Market Implications
  11. Conclusions

  • Clinical trial industry in India accounts for ~ 1% of global trials but is likely to increase up to 15%

  • Lower cost and faster recruitment potential is most important reason for it

  • Several Indian and prestigious Multi-national device based trials have already been conducted and many more are in pipeline

  • Some regulatory and local IRB Accreditation issues need still to be addressed

Dr. Adeshara has remained as the Commissioner , FDCA Gujarat State for more than 11 years and been instrumental actively involved in the process of Regulatory Reforms for Indian Medical Device Industry by Ministry Of Health & Family Welfare, Govt. of India. Being the head of FDCA in Gujarat State, which has more than 30 % contribution in the production of Pharmaceuticals and Medical Devices in India, his role has been prominent in implementation of the Regulatory Reforms while at the same time mentoring Indian Medical Device Industry for facing the challenges of reforms.

Dr. S.P. Adesara,
Executive Director, Sahajanand Medical Technologies Pvt. Ltd.
Achievements:

  • Awarded “BEST DRUG CONTROLLER OF 2002” by AIDCOF for Sincere and Outstanding Works in Drug Control Administration.

  • Indian Pharmaceutical Association has awarded “I.P.A.FELLOWSHIP 2002” for distinguished & Dedicated Service to the Profession of Pharmacy.

  • ‘DIWA’, Maharashtra State, (Drugs Inspectors Welfare Association) awarded ‘DIWA AWARD 2002’ for the Valuable Regulatory contribution in Pharmacy Profession in Gujarat.

  • Awarded “SCHROFF MEMORIAL NATIONAL AWARD - 2005” by IHPA in 57th IPC at HYDERABAD.