By D. Saidulu

Rule Permission for

122 A To import New drugs

122 B To manufacture New drugs

122 D To Import or Manufacture fixed dose combinations

122DA To conduct clinical trials for New Drug/Investigational New drug

122 DAA Definition of Clinical Trial

It shall made in Form 44 accompanied with the following data in accordance with appendices, namely

Clinical and pharmaceutical information Animal pharmacology data Animal Toxicology data Human Clinical pharmacology data Regulatory status in other countries Prescribing information

FORM 12- To import Study drug for examination , test or analysis

1. Approval for Clinical trials CT on a New drug shall be initiated only after permission by

licensing authority and approval from EC2. Responsibilities of Sponsor Implementing and maintaining QA Submit status report to the licensing authority periodically SAE should be reported to the licensing authority with in 14

calendar days.3. Responsibilities of Investigator Ensure adequate medical care is provided to the subject SAE and unexpected AE should be reported to the sponsor within

24 hrs and to the EC within 7 working days4.Informed consent Freely given informed written consent Provide information about the study verbally Non-Technically and understandable language

5.Responsibilities of ethics committee Approval trial protocol to safe guard RSW of all trial subject and

to protect RSW of all vulnerable subjects Conduct ongoing review of trials 6. Human Pharmacology (Phase I) Safety and tolerability 7. Therapeutic exploratory trials (phase II) To evaluate the effectiveness of a drug for a particular indication To determine the short term side effects and risk associated with

the drug To determine the dosage regimen for phase III trials. 8. Therapeutic confirmatory trials (phase III) Demonstration of therapeutic benefit Drug is safe and effective for use and provide and adequate

basis for marketing approval 9. Post marketing surveillance Performed after drug approval and related to the approved

indication Includes drug-drug interaction, dosage response and safety

studies , mortality/ morbidity studies

3. studies in special population1. Geriatrics 2. Pediatrics3. pregnant or Nursing Women

4. Post marketing Surveillance closely monitored new drugs clinical safety PSUR- to report all relevant new informationPSUR shall be submitted every 6months for the first 2

years5. Special Studies- BA/BE studies conducted according to the guidance for BA and BE

studiesEvaluation of the effect of food on absorption following

oral administration

APPENDIX I- Data to be submitted along with the application to conduct clinical trial/import/ manufacture of new drugs for marketing in the country.

APPENDIX I- 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.

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 (FDC)

APPENDIX VII- Undertaking by 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