Bioethics Centres IEC / IRB Accreditation Programme
- GSR 53 (E) dtd 30.1.2013-The Drugs and Cosmetics (First Amendment) Rules, 2013
- GSR 63 (E) dtd 1.2.2013-The Drugs and Cosmetics (Second Amendment) Rules, 2013
- GSR 72 (E) dtd 8.2.2013-The Drugs and Cosmetics (Third Amendment) Rules, 2013
- The Gazette Notification 07 June 2013 GSR 364 (E) AUDIO VIDEO recording of Informed consent
- Revised formula to calculate compensation for clinical trial related SAE or death
- Pharmacovigilance Programme of India News Letter-Volume 3 Issue-6,2013 Indian Pharmacopoeia Commission.
- Report of the Prof. Ranjit Roy Chaudhury on clinical trials 2013
- Report of Dr Kokate on FDCs 2013
Audio-Video Recording of Informed Consent Process of All New Subjects in Clinical Trials- Administrative Orders 2013
Actions on the Recommendations of Prof. Ranjit Roy Chaudhury Expert Committee 2013
- Office Order dated 03.07.2014 – Procedure for review of application of CT and New drugs
- Office Order dated 03.07.2014 -Limiting number of CT an Investigator can undertake at a time
- Office Order dated 03.07.2014 – Clinical Trial on Medical Device
- Office Order dated 03.07.2014 – CT Compensation in case of injury or death discerned at a later stage
- Office Order dated 03.07.2014 – Providing Ancillary Care to the Clinical Trial subjects
- Office Order dated 03.07.2014 – Approval of academic CT
- Office Order dated 03.07.2014 – Waiver of CT in Indian Population for approval of New Drugs
- Office Order dated 03.07.2014 – Consideration of ethnicity for approval of new drugs
- 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
- Office Order dated 03.07.2014 – Number of subjects in Phase III Global CT
- Office Order dated 03.07.2014 – Placebo Controlled Trials
- Office Order dated 03.07.2014 – Requirement for filing of application to market new Chemical Entities
- Office Order dated 03.07.2014 – Consideration of banning of a marketed drug
- Office Order dated 03.07.2014 – Creation of cell for co-ordination with institutes likes ICMR for sponsoring various studies
- Gazette Notification dated 8 March 2016 on Drugs and Cosmetic rules. GSR 287E
- 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
- GSR 611 (E) dated Jul 2015- regarding AV recording –clarification of vulnerable patients; definition of NCE & NME, etc.
- 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.
- 70th DTAB minutes- extension of TL from 01 to 03 years recommended (page. No. 28).
- Audiovisual Consent: New Gazette Notification, 31st July 2015
- GSR 889E Notification on CT
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