Meeting Title: LSW Round Table with K L Sharma, Joint Secretary, Ministry of Health, Dr. G N
Singh, DCGI and A K Pradhan, DDCI, May 30, 2015, Mumbai
Meeting Called by: LSW LifeScienceWorld – Supported by OPPI
Meeting Date: May 30, 2015.Venue: The Orchid, Mumbai
Chair: K L Sharma, Dr. G N Singh, A K Pradhan,
Overview: Prof (Dr.) Ranjit Roy Chaudhury
Dr. Suresh Menon and Yasmin Shenoy on behalf of industry (OPPI)
Dr. S D Banavali on behalf of Investigators and Institution
Dr.Milind Antani on behalf of LSW LifeScienceWorld
Representatives from OPPI, ISCR, Sanofi, Takeda, Abbott, Wockhardt, BMS, Bayer, GSK, Pfizer, Lambda Therapeutics, Veeda Clincal Research, ACRO India and Individual investigators and Ethics Committee members.
• Consideration of local CT data waiver for life-threatening diseases
• Training Drug Inspectors
• Inspection Checklist to be made which can be referred by the SEC committee examining the CT design
• Consideration of local CT data waiver for life-threatening diseases
• Challenges in Review and Approval Process for New Drugs/Clinical Trials (including SEC functioning)
• Accreditation of Investigators/ Sites / Ethics Committees
• Recommendations for A-V Recording
• Three Trials per Investigator
• Requirement of 50%-20% Government Sites & 50 Bedded Hospitals
• CT waiver for additional strengths / additional indications
• Post approval commitments
• GEAC working
• Company Name/Mfg. Site Name/Address Change
• Import Registration: One manufacturing Site
CDSCO is recruiting 150 new inspectors. They are ready to give one week training slot to be
conducted by the industry for them.
Checklist needs to be prepared by representative from the Industry and DCGI office.
Definition of life threatening needs to be build along with a illustrative list of medical conditions.
Detailed Scope for SEC functioning needs to be spelled out. Also an orientation exercise needs to be done for all ethics committee members.
All agreed that a detailed Standard Operating procedure needs to be created for Presubmission meetings.
CDSCO to share the rationale of why only 3 trial per investigator suggested. Nishith Desai and Associates to submit a white paper on this highlighting the pain points faced by the industry.
There is already a notification made for this issue which is currently being vetted by the law ministry. The notification tries to bring clarity on the pain points being raised by the industry and academia related to consent process.
Since the DCGI approval and GEAC approval was to happen in parallel within 45 days, the inaction being practiced by GEAC is hurting the industry badly
Rule change needed from 3 months import to 6 months import Current ongoing studies will not be impacted by this. There will be a window provided for
completing all old approved clinical trials as per the old laws.
(Recommendation draft is being prepared by OPPI on behalf of the industry and LSW
LifeScienceWorld to be sent to the Joint Secretary and DCGI office).
K L Sharma, Joint Secretary, MoHFW
Dr. G N Singh, DCGI
A K Pradhan, Asst. Drug Controller
Dr. Ranjit Roy Chaudhury
Dr. Milind Antani, (Moderator)
1. Dr. Mubarak Naqvi, Director Medical, Sanofi
2. Yasmin Shenoy, Sr. Director-Regulatory, Sanofi
3. Dr. Arun Mishra, Director Regulatory, Abbott
4. Dr. Rashmi Hegde, Director Medical Abbott
5. Jitendra Tyagi, Managing Director, Bristol Myers-Squibb
6. Ram Sundaram, Director Regulatory, BMS
7. Dr. Shubnum Singh, Chief Executive, Max Healthcare
8. Dr. Bikas Medhi, PGIMER, Chandigarh
9. Dr. Vivek Ahuja, PATH
10. Saurabh Sobti, Clinton Health Access Initiative Inc
11. Dr. Jeroze Dalal, Head-Clinical Operations, GSK
12. Dr. Suresh Menon, CSO, Novartis
13. Dr. Ajay Sharma, Director Research, OPPI
14. Rajeev Shukla, OPPI
15. Dr Saurendra Das, Excel LifeSciences
16. Dr. Kiran Marthak, Director- Global Clinical Development, Lambda Therapeutics
17. Apurva Shah, Group Managing Director, Veeda Clinical Research
18. Dr. Jyoti Bajpai, Asst. Prof. Medical Oncology, Tata Memorial Hospital
19. Swapnali Raut, Director regulatory, Pfizer
20. Dr. Rajen Shah, Direct-Raptim Research, President, ACRO Mumbai Chapter
21. Suneela Thatte, President, ISCR
22. Dr. Santosh Jha, Director, Medical, Takeda
23. Dr. Vikram Singh, Vice President-Medical Affairs & Pharmacovigilance, Johnson & Johnson
24. Dr. Akhilesh D Sharma, SVP & Chief medical Officer, Dr. Reddy’s
25. Dr. Swashraya Shah – Executive Director, Medical Affairs, MSD
26. Anirban Roychowdhury – Executive Director, Clinical Research, MSD
27. Rahul Luthra – Associate Director, Regulatory Affairs, MSD
28. Dr. Arani Chatterjee, Sr. Vice president, E Biologics
29. Dr. Bhimsen Silgiri, Head-Medical Regulatory Affairs, Wockhardt
30. Dr. Gururaj Rao, Managing Director, International Stem Cell Services Ltd
31. Jayanthi Swaminathan, Apollo Hospital
32. Dr. Ashish Gawde, County Medical Director, Bayer Pharmaceuticals
33. Dr. Nilima Kshirsagar, National Chair Clinical Pharmacology,member DTAB
ICMR Govt. of India, NIRRH
34. Dr. B M Gandhi, Former Advisor, Dept. of Biotechnology, Govt. of India
35. Dr. Vrishali Desai, Medical Director, GSK
36. Dr. S D Banavali, Head – Medical Oncology, Tata Memorial Hospital
37. Dr. Veena Jaguste, Director-Development Operations, Amgen
38. Amita Bhave, Director Regulatory, Novartis
39. Khushboo Baxi, Nishith Desai Associates
40. Anay Shukla, Nishith Desai Associates
41. Dr. Sonali Dighe, Medical Director, Pfizer
42. Shriram Balasubramanian, Director-Commercial, Zuventus healthcare
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