schedule y

schedule y

1. Schedule Y

2. CDSCO The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 11 port offices and six laboratories under its control.

3. Clinical Trials: Current Regulatory Framework 1 Drugs and Cosmetics Act,1940 & Rules,1945 ICMR Ethical guidelines,2000/2006 Indian GCP Guidelines, 2001 National Pharma.Vig . Programme , 2004 Revised Schedule Y (Drugs & Cosmetics Rules), 2005 BA/BE Study Guidelines, 2005

4. Clinical Trials: Current Regulatory Framework 1 Notification on Devices,2005 Amendment to Drugs and Cosmetic Act,2008 Notification on Clinical trial registration, 2009 Amendment to D and C Act, CRO Regn,Sch.Y-1,2009 Proposed Clinical establishment Bill,2010 Amendments in 2012 and 2013 CDSCO official order/notifications………..

5. SCHEDULE Y REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT AND / OR MANUFACTURE OF NEW DRUGS FOR SALE OR TO UNDERTAKE CLINICAL TRIALS

6. Rule 122DA Schedule Y of The D&C Act D & C Rules 1945 Application for permission to conduct clinical trials for New Drug/Investigational New Drug.− No clinical trial for a new drug, whether for clinical investigation or any clinical experiment by any institution, shall be conducted except under, and in accordance with, the permission, in writing, of the Licensing Authority defined in clause (b) of Rule 21. Forms Form 44 Form 45 , 45-A, 46, 46-AS

7. Definition of new drug A drug, as defined in the Act including bulk drug substance which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labeling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims: Provided that the limited use, if any, has been with the permission of the licensing authority. A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration . A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration.

8. Application fees

9. Schedule Y requirements for Clinical Trial conduct Approval of the clinical trial Responsibilities of Sponsor Responsibilities of the Investigator(s) Informed Consent Responsibilities of the Ethics Committee Human Pharmacology (Phase I) Therapeutic exploratory trials (Phase ?) Therapeutic confirmatory trials (Phase ?) Post Marketing Trials (Phase IV)

10. Schedule Y requirements for Clinical Trial conduct Studies in special populations Geriatrics Pediatrics Pregnant or nursing women Post Marketing Surveillance Special studies: Bioavailability/Bioequivalence Studies

11. Appendices APPENDIX I -Data to be submitted along with the application to conduct clinical trials/import/manufacture of new drugs for marketing in the country APPENDIX IA -Data required to be submitted by an applicant for grant of permission to import and / or manufacture a new drug already approved in the country

12. Appendices APPENDIX II -Structure, contents and format for clinical study reports APPENDIX III -Animal toxicology (non-clinical toxicity studies) APPENDIX IV –Animal pharmacology APPENDIX V -Informed consent APPENDIX VI -FIXED DOSE COMBINATIONS ( fdcs )

13. Appendices APPENDIX VII -Undertaking by the investigator APPENDIX VIII -Ethics committee APPENDIX IX -Stability testing of new drugs APPENDIX X -Contents of the proposed protocol for conducting clinical trials APPENDIX XI -Data Elements for reporting serious adverse events occurring in a clinical trial APPENDIX XII –Compensation clause added recently.

14. Recent Updates CDSCO has released 14 orders on July 3, 2014 that may impact Clinical Trials in India. These orders are based on the recommendations made by the Prof. Ranjit Roy Choudhary committee report. Kindly visit the following link for full orders: http :// www.cdsco.nic.in/forms/list.aspx?lid=1843&Id=31

15. Recent Updates NDACs have been replaced as Subject Expert Committees (SECs). Members for the meetings shall be drawn randomly from a large pool of experts. Applications reviewed by SECs will then be reviewed by Technical Review Committees (TRC) TRC is proposed to be constituted under DGHS consisting of experts from each area. Full notification: http:// www.cdsco.nic.in/writereaddata/officer%20order%201.pdf

16. Recent Updates Number of trial by an investigator: Under no circumstances can an investigator be involved in more than 3 clinical trials at one time. Full notification: http:// www.cdsco.nic.in/writereaddata/officer%20order%202.pdf Clinical Trials of medical devices: For clinical trials of medical devices, procedure for clinical trial approval, accreditation of investigators, sites, Ethics Committees and such other conditions shall be similar to clinical trials of new drugs / vaccines. Full notification: http:// www.cdsco.nic.in/writereaddata/oo3.pdf

17. Recent Updates With regard to compensation in case of injury or death discerned at a later stage, compensation should be paid to trial participant / his / her nominee if any drug related anomaly is discerned at a later stage and accepted to be drug related. Full notification: http :// www.cdsco.nic.in/writereaddata/oo4.pdf Providing ancillary care to clinical trial subjects: There should be provision for providing ancillary care to patients suffering from any other illness during the trial. Full notification: http:// www.cdsco.nic.in/writereaddata/oo5.pdf

18. Recent Updates Academic research may be approved by institutional EC. However, if a new drug is being evaluated or new use for an existing drug is being evaluated, then approval of DCGI is also needed. Full notification: http :// www.cdsco.nic.in/writereaddata/oo6.pdf Waiver of clinical trial in Indian population for approval of new drugs which have already been approved outside India can presently be considered only in case of national emergency, extreme urgency, and epidemic and for orphan drugs for rare diseases and drugs indicated for conditions / diseases for which there is no therapy. Full notification: http:// www.cdsco.nic.in/writereaddata/oo7.pdf

19. Recent Updates With regard to ethnicity: Various factors of a compound which should be considered in regard to ethnicity of a new drug are defined in the notification. NDAC experts shall be considering these factors while reviewing Clinical Trial applications. Full notification: http :// www.cdsco.nic.in/writereaddata/oo8.pdf Drugs considered generics and similar biologicals in other countries like USA that have been marketed in these countries for more than 4 years and have a satisfactory report would be approved for marketing in India after abbreviated trials. Full notification: http :// www.cdsco.nic.in/writereaddata/oo9.pdf

20. Recent Updates Number of subjects in Phase III Clinical Trials: If Indians have participated in Phase III global clinical trials, the number of participants would have to be adequate for consideration for approval in India. Full notification: http :// www.cdsco.nic.in/writereaddata/oo10.pdf Placebo controlled trials: All the sponsors / CROs / Clinical Trial Applicants / Ethics Committees are required to ensure that the design used in placebo controlled clinical trial is appropriate, ethical and efficient. Full notification: http :// www.cdsco.nic.in/writereaddata/oo11.pdf

21. Recent Updates Requirement for filing of application for marketing of NCE: All sponsors / Clinical Trial applicants are directed to provide an undertaking to CDSCO along with application for approval of clinical trials of NCEs to be used for diseases that are prevalent in our population, after approval for marketing in the innovator country or in well developed regulated markets. Approval should be sought for marketing these NCEs in India. Full notification: http :// www.cdsco.nic.in/writereaddata/oo12.pdf Consideration of banning of a marketed drug: If two or more countries remove a drug from their market on grounds of efficacy and safety, then the continued marketing of the drug in the country will be considered for examination and appropriate action. Full notification: http :// www.cdsco.nic.in/writereaddata/oo13.pdf

22. Recent Updates Creation of cell for coordination with institutes like ICMR for sponsoring various studies: A cell has been constituted in CDSCO to coordinate with agencies such as ICMR for conduct of specific studies for post marketing surveillance of drugs, rational use of medicines, drug utilization studies, adverse drug reaction monitoring, etc. Full notification: http ://www.cdsco.nic.in/writereaddata/oo14.pdf

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