Scribd
Upload
642 views11 pages

Schedule y

This document outlines the rules and permissions required for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the application process and required data, including clinical and pharmaceutical information, animal studies, human clinical pharmacology data, and prescribing information. It describes the responsibilities of sponsors, investigators, and ethics committees. It also summarizes the different phases of clinical trials - including human pharmacology, therapeutic exploratory trials, therapeutic confirmatory trials, and post-marketing surveillance. Special studies like those in geriatrics, pediatrics, or pregnant women are also mentioned. Appendices provide more details on specific requirements and guidelines.

Uploaded by

Siva Prasad
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
642 views11 pages

Schedule y

This document outlines the rules and permissions required for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the application process and required data, including clinical and pharmaceutical information, animal studies, human clinical pharmacology data, and prescribing information. It describes the responsibilities of sponsors, investigators, and ethics committees. It also summarizes the different phases of clinical trials - including human pharmacology, therapeutic exploratory trials, therapeutic confirmatory trials, and post-marketing surveillance. Special studies like those in geriatrics, pediatrics, or pregnant women are also mentioned. Appendices provide more details on specific requirements and guidelines.

Uploaded by

Siva Prasad
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 11

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


Application for permission

Clinical Trial

Studies in Specific Population

Post Marketing Surveillance

Special Studies : BA/BE studies


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

You might also like