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 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

 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 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

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