3. 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
5. 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
6. 1. Approval for Clinical trials
CT on a New drug shall be initiated only after permission by licensing
authority and approval from EC
2. 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 days
4.Informed consent
Freely given informed written consent
Provide information about the study verbally
Non-Technically and understandable language
7. 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
8. 3. studies in special population
1. Geriatrics
2. Pediatrics
3. pregnant or Nursing Women
4. Post marketing Surveillance
closely monitored new drugs clinical safety
PSUR- to report all relevant new information
PSUR shall be submitted every 6months for the first 2 years
5. Special Studies- BA/BE studies
conducted according to the guidance for BA and BE studies
Evaluation of the effect of food on absorption following oral
administration
9.
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
