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SCHEDULE Y
SUBMITTED
BY
Mr. AKSHAY A. JOSHI
ICBIO BANGALORE
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OBJECTIVES OF D & C ACT1940
The Drugs and Cosmetics Act 1940
provides the central legislation, which
regulates import, manufacture,
distribution & sale of drugs & cosmetics in thecountry.
The main objective of the Act is to ensure
that the drugs available to the people are
safe and efficacious and the cosmetics marketed
are safe for use.
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Drug and cosmetic act 1945
Rule Permission for
122
A - Import
B - Manufacture [except drugs underschedule C and C(1)]
D -Fixed dose combinations
DA - Clinical Trial
DAA - CT Definition
E - New Drug Definition
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Conti
122 DAA
Clinical Trial Definition
Systematic study of new drugs in human subjects; To
generate data for discovering/verifying clinical safety,pharmacological (PK & PD) or adverse effects; To
determine safety and efficacy of the new drug
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Conti..
122 ENew drug definition
Not used in the country
Approved drug : 1. New claims
(Indications,dosage,
dosage form, route)
2. FDCs
(New / Modified)
Note : Vaccines are new drugs unless
1. Certified
2. Till 4 year or
3. Included in IP
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SPONSORS RESPONSIBILITIES
Quality Assurance : Adopt GCP Guidelines Trial Status
Report to Licensing Authority : Annually Premature
Termination : Summary report within 3 month
( Study, Pt. no., Dose, Duration, ADR &reasons for discontinuation )
Serious Adverse Event : Report to RA & other
investigators within 14 days
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INVESTIGATORS RESPONSIBILITIES
Adhere to approved Protocol & GCP
Guidelines
Document SOPs
Management of all ADR / AE
Reporting unexpected AE to :
- Sponsor within 24 hours
- EC within 7 days
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EC RESPONSIBILITIES
Safeguard rights, safety & well being
Protect vulnerable subjects
Obtain and maintain record of SOPs Ongoing review based on Periodic progress
report
If EC revokes its approval
- Record reasons for it- Inform the Investigator & LA immediately
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ESSENTIAL STEPS OF CLINICAL
PHARMACOLOGY
Phase I (Human Pharmacology)
Safety & Tolerability ( PK, PD & MTD
Phase II (Th. Exploratory Trial)Therapeutic benefits in few patients
Phase III (Th. Confirmatory Trial)
Therapeutic benefit in more patientsPhase IV (Post Marketing Trials)
Related to Approved indication
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overview
Schedule Y what it covers and associated
rules
Application for permission underform 44,regulatory authorities and fees
Important consideration
Appendices of Schedule Y
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Schedule Y
Requirements & Guidelines for permission to IMPORT & / OR
MANUFACTURE of new drugs for SALE or to UNDERTAKECLINICAL TRIALS.
AMENDMENT OF SCHEDULE Y:The Ministry Of Health & Family Welfare In Jan2005 issued a
notification amending Schedule Y of Drugs & Cosmetic Rules
Now permits concurrent phase II & phase III trials in India
Why India ForClinical Trials ?
Ideal location for undertaking economical clinical trials
which cost less than in developed countriescan meet international standards
large & heterogeneous population of people with
infectious diseases
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Appendix X
Contents Of The Proposed Protocol
For Conducting Clinical Trials
Appendix IX
Stability Testing Of New Drugs
Appendix VIII
Ethics Committee
Appendix VII
Undertaking by the InvestigatorAppendix VI
Fixed Dose Combinations (Fdcs)
Appendix V
Informed ConsentAppendix IV
Animal pharmacology
Appendix III
Animal toxicology (non-clinical toxicity studies)
Appendix II
Structure, contents & format for clinical
study reports
Appendix I-A
Data required to be submitted by an
applicant for grant of permission to import
&/or manufacture a new drug already approved
in the country.
Appendix I
Data to be submitted along with the application
to conduct clinical trials / import / manufactureof new drugs for marketing in the country.
Appendix XI
Data Elements For Reporting Serious
Adverse Events Occurring In A Clinical Trial.
List of Appendices For Schedule Y
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Appendices I : Data to be submitted along with theapplication to conduct clinical trials/import/manufacture of new
drugs for marketing in the country
i. Introduction (About the drug and the therapeutic class )
ii. Chemical and pharmaceutical information
iii. Animal Pharmacology
iv. Animal Toxicology (Non-clinical Toxicity Studies)v. Human / Clinical pharmacology (Phase I)
vi. Therapeutic exploratory trials (Phase II)
vii. Therapeutic confirmatory trials (Phase III)
viii. Special studies(BA/BE, pregnant, children)
ix. Countries where the drug is approved
x. Prescribing information
xi. Samples and Testing Protocol
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AppendicesI-A: Data required to be submitted by anapplicant for grant of permission to import &/or manufacture a
new drug already approved in the country
i. Introduction (About the drug and the therapeutic class )
ii. Chemical and pharmaceutical information ()
iii. Marketing information
iv. Special studies(BA/BE, pregnant, children)
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Cont.
9.Study Objective(purpose)10.Investigational Plan: (Trial design, the Subject
selection, the treatment procedures, the data quality
assurance procedures and the statistical methods)
11.Trial Subjects12. Efficacy evaluation :Results
13. Safety Evaluation :Complete list
13.1 all serious adverse events, whether expected or
unexpected and13.2 unexpected adverse events whether serious or not
14. Discussion and overall Conclusion
15. List of References
16.Appendices for Clinical Study Reports
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APPENDIX IV ANIMAL PHARMACOLOGY
Cardiovascular System
Central Nervous System Respiratory System
o Follow up and Supplemental Safety Pharmacology
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APPENDIX VINFORMED CONSENTEssential Elements:
Voluntary participation
Study involves research and its purpose & Expected
duration of participation
Description of the procedures
Description of foreseeable risks or benefits to subject
Alternative procedures or therapies
Statement describing confidentiality of records
Trial treatment schedule(s)
Compensation and/or treatment
Whom to contact, rights of Subjects in the AE
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Cont
Additional elements, which may be required
Foreseeable circumstances under which the Subject's
Participation may be terminated without the Subject's
consent Additional costs to the Subject
Consequences to withdraw from the research and
procedures for orderly termination Notification in a timely manner if significant new findings
develop which may affect the Subject's willingness to
continue participation.
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APPEND VIFIXED DOSE COMBINATIONS
Fixed Dose Combinationreferto products containingone
ormore active ingredients used fora particularindication.
GROUP 1 : One or more of the active ingredients is a newdrug. Marketing data will be similar to data required for anynew drug (including clinical trials) (rule 122E)
GROUP 2 : Active ingredients already approved/marketedindividually. appropriate chemical and pharmaceutical datawill be submitted.
GROUP 3 : Already marketed, but in which it is proposedeither to change the ratio of active ingredients.
GROUP4 : Individual active ingredients have been widelyused in a particular indication(s) for years,
It will have to be demonstrated that the proposed dosageform is stable
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APPENDIX VIIUNDERTAKING BYINVESTIGATOR
Full name, address and title and MCR number of the
PI
Name/address of medical college, hospital or other
facility where the clinical trial will be conducted. Names of other members of the research team
Name and address of the Ethics Committee
Protocol Title and Study number
Signature of Investigator with Date on Commitments:
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APPENDIX VIIIETHICS COMMITTEE At least seven members
Should appoint Chairperson (who is from outside the
institution) and a Member Secretary.
Quorum at least 5 members with the following
representations:
1.basic medical scientists (preferably one
pharmacologist).
2.clinicians
3.legal expert
4.social scientist / representative of NGO voluntary
agency /philosopher / ethicist / theologian or a similar
person
5.lay person from the community
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APPENDIX IXSTABILITY TESTING OF NEW
DRUGS
.Evidence on how the quality of a drug substance or
formulation varies with time under the influence of
various environmental factors
To establish shelf life for the formulation /
recommended storage
Validated stability-indicating analytical procedures
Stress testing of the drug substance on single batch to
identify degradation products
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APPENDIX X PROPOSED PROTOCOL
1. Title Page - Full title, Protocol / Study number, and
Protocol version number with date, The INDname/number, Complete name and address of theSponsor and CRO, List of the Investigators,
2. Table of Contents
1. Background and Introduction-Preclinicalexperience, Clinical experience
2. Study Rationale
3. Study Objective(s)
3. Study Design
4. Study Population5. Subject Eligibility
1. Inclusion Criteria
2. Exclusion Criteria
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Cont.
6. Study Assessments
7. Study Conduct8. Discontinued Subjects(on which criteria)
9. Study Treatment (Dosing Schedule, route ofadministration, dose modification etc..
10. Unblinding procedures
11. Adverse Events
12. Ethical Considerations
13. Study Monitoring and Supervision
14. Investigational Product Management
15. Data Analysis
16. Undertaking by the Investigator
17. Appendices
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APPENDIX XIDATA FOR REPORTING SAE1. Patient Details
1. Initials & other relevant identifier (hospital/OPDrecord number etc.) Gender, Age and/or date
of birth
2. Weight & Hight
2. Suspected Drug(s)
1. Generic name of the drug & Indication
2. Dosage form and strength
3. Daily dose and regimen
4. Route of administration
5. Starting & Stopping date and time of day
3. Other Treatment(s)
4. Details of Suspected Adverse Drug Reaction
5. Outcome Information
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Revised Old
1. Applicationforpermission 1.1 Nature oftrials2. Clinical trial 1. Clinical trials
(1) Approval forclinical trial 1.2 Permissionfortrials
(2)ResponsibilitiesofSponsor1.3ResponsibilitiesofSponsor/Investigator
(3)Responsibilitiesofthe Investigator(s)
(4) Informed Consent New
(5)ResponsibilitiesofECs - New
(6) Human Pharmacology (Phase I) 5. Human clinical pharmacology (Phase I)
(7) Therapeutic exploratory trials(Phase II) 6. Exploratory trials(Phase II)
(8) Therapeutic confirmatory trials(Phase II) 7. Confirmatory trials(Phase II)
(9) Post Marketing Trials(Phase IV) New
3. Studiesinspecial populations 8. Special studies(1) Geriatrics
(2) Pediatrics
(3) Pregnantornursing women
4. Post Marketing Surveillance 12. Post-marketingsurveillance study
5. Special studies: BA/BE Studies New
Schedule Y 2005
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Revised Old
Data to be submitted along with the application
to conduct clinical trials/import/manufacture of
new drugs for marketing in the country
Data required to be submitted with application to
for permission to market a new drug
2.1 Information on active ingredients 2.3 Specifications of active and inactive
ingredients
2.2 Physicochemical Data 2.1 Physicochemical proportion
2.3 Analytical data New
2.4 Monograph specification 2.4 Tests for identification of the active
ingredient and method of its assay
2.5 Validations new
2.7 Data on Formulation 2.2 and 2.5
3.4 Safety Pharmacology New
4.3 Male Fertility Studies New
4.6 Allergenicity/Hypersensitivity New
11. Samples and Testing Protocols 10.3 Samplewith testing protocol
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Conclusion
When you start investigating a newmolecular entity, think it will be registeredaround the world and will provide a cure to
a specific disease, then the main concernis to ensure the finished product reachesthe population with approved criteria forQUALITY, EFFICACY and SAFETY
Every country has its own regulations andapproval process THAT MUST BE TAKENINTO CONSIDERATION
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