• Office orders by CDSCO on 3rd July 2014 have been updated under Notifications section. (Serial No : 11 – 24)
  • New updates added under notification from CDSCO (24 Nov 2016)

Guidelines

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).

click here to close

Bioethics Centres IEC / IRB Accreditation Programme