Whats New

Guidelines

 

  1. The Belmont report (1979)
  2. Declaration of Helsinki- WMA policy 2008
  3. International Ethical Guidelines for Biomedical Research Involving Human Subjects- CIOMS (2002)
  4. ICH guidelines (2005)
  5. CDSCO guidelines for new drug approval (2011)
  6. Clinical Safety Data Management : Definitions & Standards for  Expedited Reporting : ICH Harmonised Tripartite Guideline (1995)
  7. Guidance on Clinical trial inspection (2010)- CDSCO
  8. Guidance for Clinical trial sponsors (2006)- CDSCO
  9. OHRP guidelines Guidance for Clinical Investigators, Institutional Review boards and Sponsors.(2006)
  10. Guideline for Good Clinical Practice (2002)
  11. Ethical Guidelines- ICMR (2006)
  12. GCLP guidelines- ICMR (2008)
  13. Guidelines for Exchange of Human Biological Material  for Biomedical Research Purposes- ICMR (1997)
  14. UNESCO guidelines for educating Bioethics Committees (2007)
  15. Standards and Operational Guidance for Ethics review of Health related research with Human participants- WHO (2011)
  16. EFGCP Guidelines on Medical Research for and with Older People in Europe (2013
  17. Schedule Y law- REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT AND l OR MANUFACTURE OF NEW DRUGS FOR SALE OR TO UNDERTAKE CLINICAL TRIALS (1945)
  18. Schedule Y law- REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT AND l OR MANUFACTURE OF NEW DRUGS FOR SALE OR TO UNDERTAKE CLINICAL TRIALS (2005)
  19. Guidelines on Code of Conduct for Research Scientists engaged in field of Life Sciences (2014)
  20. ICMR-DBT Guidelines on Stem Cell Research (2013)
  21. Quantum of compensation formulae

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Notifications

  1. GSR 53 (E) dtd 30.1.2013-The Drugs and Cosmetics (First Amendment) Rules, 2013
  2. GSR 63 (E) dtd 1.2.2013-The Drugs and Cosmetics (Second Amendment) Rules, 2013
  3. GSR 72 (E) dtd 8.2.2013-The Drugs and Cosmetics (Third Amendment) Rules, 2013
  4. The Gazette Notification 07 June 2013 GSR 364 (E) AUDIO VIDEO recording of Informed consent
  5. Revised formula to calculate compensation for clinical trial related SAE or death
  6. Pharmacovigilance Programme of India News Letter-Volume 3 Issue-6,2013 Indian Pharmacopoeia Commission.
  7. Report of the Prof. Ranjit Roy Chaudhury on clinical trials 2013
  8. Report of Dr Kokate on FDCs 2013
  9. Audio-Video Recording of Informed Consent Process of All New Subjects in Clinical Trials- Administrative Orders 2013

  10. Actions on the Recommendations of Prof. Ranjit Roy Chaudhury Expert Committee 2013

  11. Office Order dated 03.07.2014 – Procedure for review of application of CT and New drugs
  12. Office Order dated 03.07.2014 -Limiting number of CT an Investigator can undertake at a time
  13. Office Order dated 03.07.2014 – Clinical Trial on Medical Device
  14. Office Order dated 03.07.2014 – CT Compensation in case of injury or death discerned at a later stage
  15. Office Order dated 03.07.2014 – Providing Ancillary Care to the Clinical Trial subjects
  16. Office Order dated 03.07.2014 – Approval of academic CT
  17. Office Order dated 03.07.2014 – Waiver of CT in Indian Population for approval of New Drugs
  18. Office Order dated 03.07.2014 – Consideration of ethnicity for approval of new drugs
  19. Office Order dated 03.07.2014 – Requirement of local trial for a generics or similar biologics (bio similar) in other country like USA for its approval in the country
  20. Office Order dated 03.07.2014 – Number of subjects in Phase III Global CT
  21. Office Order dated 03.07.2014 – Placebo Controlled Trials
  22. Office Order dated 03.07.2014 – Requirement for filing of application to market new Chemical Entities
  23. Office Order dated 03.07.2014 – Consideration of banning of a marketed drug
  24. Office Order dated 03.07.2014 – Creation of cell for co-ordination with institutes likes ICMR for sponsoring various studies
  25. Gazette Notification dated 8 March 2016 on Drugs and Cosmetic rules. GSR 287E
  26. GSR 1011 (E) dated Dec 2015- DRAFT gazette revision of fees for various types of applications including CTA…from Rs 25K to Rs 2.5L
  27. GSR 611 (E) dated Jul 2015- regarding AV recording –clarification of vulnerable patients; definition of NCE & NME, etc.
  28. GSR 826 (E) dated Oct 2015- regarding explanation of GCT, nCE, NME + 3 criteria of innovation, unmet medical need, risk vs benefit for NDA’s & GCT.
  29.  70th DTAB minutes- extension of TL from 01 to 03 years recommended (page. No. 28).
  30. Audiovisual Consent: New Gazette Notification, 31st July 2015
  31. GSR 889E Notification on CT

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Bioethics Centres IEC / IRB Accreditation Programme