IMPORTANT AMENDMENTS TIMELINE
| Amendment | Date | GSR No. | Key Changes |
|---|---|---|---|
| Original Rules | 19 March 2019 | GSR 227(E) | Base rules notified |
| 1st Amendment | 14 October 2022 | GSR 778(E) | Deemed approval mechanism introduced; timelines fixed |
| 2nd Amendment | 19 September 2024 | GSR 581(E) | CRO Registration (Chapter VA); Effective from 1 April 2025 |
| 3rd Amendment | 20 January 2026 | GSR 46(E) | "Prior Intimation" route; timelines reduced from 90 to 45 working days |
| 4th Amendment | 21 January 2026 | GSR 50(E) | Prior Intimation for BA/BE studies (export purposes) |
CHAPTER I: PRELIMINARY (Rules 1-2)
Rule 1: Short Title, Commencement & Applicability
| Aspect | Details |
|---|---|
| Short Title | New Drugs and Clinical Trials Rules, 2019 |
| Commencement | From date of publication in Official Gazette (19 March 2019) |
| Special Commencement | Chapter IV (Ethics Committee for Biomedical & Health Research) came into force after 180 days |
| Applicability | All new drugs, investigational new drugs, clinical trials, bioequivalence studies, bioavailability studies, and Ethics Committees |
Rule 2: Definitions
| Term | Definition |
|---|---|
| Academic Clinical Trial | CT of already approved drug for new indication/route/dose/dosage form; results for academic purposes ONLY; NO marketing approval sought |
| Active Pharmaceutical Ingredient (API) | Substance providing pharmacological activity; diagnosis, cure, mitigation, treatment, prevention of disease |
| Adverse Event | Any untoward medical occurrence during treatment that does NOT necessarily have relationship with treatment |
| Bioavailability Study | Study to assess rate and extent of drug absorption from pharmaceutical formulation |
| Bioequivalence Study | Study to establish absence of statistically significant difference in rate and extent of absorption between test and reference formulation |
| Central Licencing Authority (CLA) | Drugs Controller, India (Rule 3) |
| Clinical Trial | Systematic study in human subjects to discover/verify clinical, pharmacological, adverse effects; objective = safety, efficacy, tolerance |
| Ethics Committee | For CT: Constituted under Rule 7, registered under Rule 8; For Biomedical Research: Constituted under Rule 16, registered under Rule 17 |
| Global Clinical Trial | CT conducted in more than one country |
| Investigational New Drug (IND) | New chemical/biological entity NOT approved for marketing in ANY country |
| New Chemical Entity (NCE) | Substance not approved by any drug regulatory authority; proposed to be developed as new drug for FIRST time |
| New Drug | (i) Not used significantly in India; (ii) Approved drug with modified/new claims; (iii) Fixed dose combination first time; (iv) Modified/sustained release form; (v) Vaccine, r-DNA, LMO, monoclonal antibody, cell/stem cell derived, gene therapeutic, xenografts |
| Orphan Drug | Drug intended to treat condition affecting NOT MORE than 5 lakh persons in India |
| Phytopharmaceutical Drug | Purified and standardized fraction with minimum FOUR bio-active/phytochemical compounds; NOT for parenteral route |
| Serious Adverse Event (SAE) | Death, permanent disability, hospitalization (outdoor), prolongation of hospitalization (indoor), congenital anomaly, birth defect, life-threatening event |
| Similar Biologic | Biological product similar in quality, safety, efficacy to reference biological product |
| Sponsor | Person, company, institution, or organization responsible for initiation and management of CT |
📝 EXAM TIP: New drugs (except iv & v) remain new drugs for 4 years from date of permission. Drugs under (iv) & (v) are ALWAYS deemed new drugs.
CHAPTER II: AUTHORITIES AND OFFICERS (Rules 3-5)
Rule 3: Central Licencing Authority
- Drugs Controller, India appointed by Central Government in Ministry of Health & Family Welfare
- Also called: DCGI (Drugs Controller General of India)
Rule 4: Delegation of Powers
- DCGI may delegate powers to officer not below rank of Assistant Drugs Controller
- Officer exercises powers under CLA's name and direction
Rule 5: Controlling Officer
- DCGI may designate any officer not below rank of Assistant Drugs Controller (India)
- Specifies areas and powers by order
CHAPTER III: ETHICS COMMITTEE FOR CLINICAL TRIAL, BA/BE STUDY (Rules 6-14)
Rule 6: Requirement of Ethics Committee
- MANDATORY to have approval of registered Ethics Committee for:
- Clinical trials
- Bioavailability studies
- Bioequivalence studies
Rule 7: Constitution of Ethics Committee for Clinical Trial
| Requirement | Details |
|---|---|
| Minimum Members | 7 members |
| Lay Person | At least 1 |
| Woman Member | At least 1 |
| Legal Expert | At least 1 |
| Independent Member | At least 1 (social scientist/NGO rep/philosopher/ethicist/theologian) |
| Non-affiliated Members | At least 50% of members NOT affiliated with institute |
| Chairperson | Must be NON-AFFILIATED member |
| Member Secretary | Must be AFFILIATED member |
| Medical Scientists/Clinicians | Post-graduate qualification + adequate experience |
| Conflict of Interest | No member with COI shall be involved in oversight |
📝 EXAM TIP: Chairperson MUST be from outside the institution; Member Secretary MUST be from inside.
Rule 7(7): Training Requirement
- Every member must undergo training as specified by CLA
- Member who has NOT completed training is DISQUALIFIED and ceases to be member
Rule 8: Registration of Ethics Committee
| Aspect | Details |
|---|---|
| Application Form | CT-01 |
| Registration Form | CT-02 |
| Timeline for Decision | 45 working days |
| Deemed Registration | If NO communication within 45 working days → deemed granted |
| Deemed Registration Form | CT-02A |
| Validity | 5 years from date of issue |
| Renewal Application | 90 days prior to expiry |
| Appeal Period | 60 working days to Central Government |
Rule 11: Functions of Ethics Committee
- Review and approve CT/BA/BE protocol
- Ongoing review at appropriate intervals
- Indicate reasons for rejection/modification in writing
- Analyze SAE documents and forward report to CLA
- May order discontinuation/suspension if trial compromises subject safety
- Allow CLA-authorized officer to inspect premises
- Comply with additional requirements specified by CLA
Rule 12: Proceedings of Ethics Committee
- Quorum: Minimum 5 members required:
- Medical scientist (preferably pharmacologist)
- Clinician
- Legal expert
- Social scientist/NGO rep/philosopher/ethicist/theologian
- Lay person
Rule 13: Maintenance of Records
- Maintain records for 5 years after completion of CT/BA/BE study
Rule 14: Suspension/Cancellation of EC Registration
- Actions CLA may take:
- Withdraw show cause notice
- Issue warning
- Reject results of CT/BA/BE study
- Suspend or cancel registration
- Debar members from overseeing CT in future
CHAPTER IV: ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH (Rules 15-18)
Rule 15: Requirement
- Any institution conducting biomedical and health research must have Ethics Committee
Rule 16: Constitution
- As per National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (ICMR)
- Must review work before initiation and oversee throughout
Rule 17: Registration
| Aspect | Clinical Trial EC (Rule 8) | Biomedical Research EC (Rule 17) |
|---|---|---|
| Registering Authority | CLA (DCGI) | Authority designated by Central Government in MoHFW, DHR |
| Provisional Registration | Not applicable | 2 years validity |
| Final Registration | CT-02 directly | CT-03 after scrutiny |
| Validity | 5 years | 5 years (final) |
| Timeline | 45 working days | 45 working days |
📝 EXAM TIP: Biomedical Research ECs have a 2-year provisional registration first, then final registration. Clinical Trial ECs get direct final registration.
CHAPTER V: CLINICAL TRIAL, BA/BE STUDY (Rules 19-38)
PART A: CLINICAL TRIAL
Rule 19: Clinical Trial of New Drug/IND
- NO person/institution/organization shall conduct CT without:
- Permission from CLA
- Protocol approved by registered Ethics Committee
Rule 21: Application for CT Permission
- Form: CT-04
- Accompanied by: Information as per Second Schedule + Fee as per Sixth Schedule
- Fee waiver for CT conducted by Central/State Government funded/owned institutions
Rule 22: Grant of Permission
| Aspect | Details |
|---|---|
| Approval Form | CT-06 |
| Timeline (General) | 90 working days |
| Deemed Approval | If NO communication within 90 working days |
| Deemed Approval Form | CT-06A |
| Reconsideration | Within 60 working days of rejection (with fee) |
| Appeal | Within 45 working days to Central Government |
Rule 23: CT for Drug Discovered/Developed in India (Fast Track)
- Timeline: 30 working days (NOT 90 days)
- If no communication → deemed approval
- Deemed approval form: CT-04A (called "automatic approval")
Rule 24: CT for Drug Already Approved Outside India
- Timeline: 90 working days
- If no communication → deemed approval (CT-06A)
Rule 25: Conditions of Permission
| Condition | Details |
|---|---|
| EC Approval | Required at each site before initiation |
| Alternative EC | If site has no EC → approval from another registered EC within same city or 50 km radius |
| Rejected Protocol | Details must be submitted to CLA before seeking another EC approval |
| Inform CLA | Within 15 working days of EC approval |
| CTRI Registration | Must register with Clinical Trial Registry of India (CTRI) before enrolling first subject |
| Quarterly Status | Enrolment status submitted quarterly |
| Six-Monthly Report | Status (ongoing/completed/terminated) via SUGAM portal |
| Termination | Reasons within 30 working days |
| SAE Reporting | Within 14 days to CLA, EC Chairperson, Head of Institution |
| Injury Compensation | Details within 30 working days of CLA order |
| Death/Permanent Disability | Compensation details within 30 working days of CLA order |
| Inspection | Premises open for CLA inspection |
| Post-Trial Access | Submit application for import/manufacture if drug found useful |
📝 EXAM TIP: CTRI registration is MANDATORY before enrolling first subject. SAE must be reported within 14 days.
Rule 26: Validity of CT Permission
- 2 years from date of issue
- Extendable by 1 year on written request
Rule 27: Post-Trial Access
- Provided FREE OF COST by sponsor if:
- No alternative therapy available + drug found beneficial
- Subject/legal heir consents in writing
- Sponsor has NO liability for post-trial use
Rule 28: Academic Clinical Trial
- NO permission from CLA required if:
- Academic research purposes only
- Prior EC approval obtained
- Results NOT submitted to CLA
- Results NOT used for promotional purposes
- EC must inform CLA within 30 working days if overlap/doubt exists
- CLA must respond within 30 working days; else presumed no permission needed
PART B: BA/BE STUDY (Rules 31-38)
Rule 31: BA/BE Study Requirements
- NO BA/BE study without:
- Permission from CLA
- Protocol approved by registered EC
Rule 33: Application for BA/BE Permission
- Form: CT-05
- Fee as per Sixth Schedule
- Fee waiver for Central/State Government funded/owned institutions
Rule 34: Grant of Permission
| Aspect | Details |
|---|---|
| Approval Form | CT-07 |
| Timeline | 90 working days |
| Deemed Approval | If NO communication within 90 working days |
| Deemed Approval Form | CT-07A |
| Reconsideration | Within 60 working days |
| Appeal | Within 45 working days |
Rule 35: Conditions of BA/BE Permission
| Condition | Details |
|---|---|
| EC Approval | Required at each centre |
| Alternative EC | Within same city or 50 km radius |
| Inform CLA | Within 15 working days of EC approval |
| Registered Centre | Must be conducted in BA/BE centre registered under Rule 47 |
| CTRI Registration | For IND BA/BE studies |
| Termination | Reasons within 30 working days |
| SAE Reporting | Within 14 days |
| Injury/Death | Medical management + compensation as per Chapter VI |
| Initiation Timeline | Enroll first subject within 1 year of permission |
Rule 36: Validity of BA/BE Permission
- 1 year from date of issue
- Extendable by 1 year in exceptional circumstances
CHAPTER VI: COMPENSATION (Rules 39-43)
Rule 39: Compensation for Injury or Death
| Scenario | Compensation | Additional Detail |
|---|---|---|
| Death | Financial compensation to legal heir by sponsor | In addition to medical management expenses |
| Permanent Disability | Financial compensation to trial subject by sponsor | In addition to medical management expenses |
| Other Injury | Quantum commensurate with loss of wages (Seventh Schedule) | In addition to medical management expenses |
| Medical Management | FREE medical management by sponsor | Required |
- Sponsor must give UNDERTAKING with CT application
- Failure to compensate → CLA may suspend/cancel CT, restrict sponsor
Rule 40: Medical Management
- Sponsor provides FREE medical management as long as required by investigator OR until injury proven unrelated to CT, whichever is earlier
Rule 41: CT-Related Injury/Death/Permanent Disability
- Considered CT-related if caused by:
- Adverse effect of investigational product
- Violation of approved protocol, scientific misconduct, negligence
- Failure of investigational product to provide intended therapeutic effect (when standard care/rescue medication not provided)
- Not providing required standard care in placebo-controlled trial
- Adverse effects due to concomitant medication (excluding standard care)
- Adverse effect on child in-utero due to parent's participation
- Any CT procedure leading to SAE
Rule 42: Procedure for Compensation
For DEATH Cases:
| Step | Timeline | Action |
|---|---|---|
| 1 | 24 hours | Investigator reports SAE to CLA, sponsor, EC |
| 2 | 14 days | Sponsor/investigator forward reports to CLA, Head of Institution |
| 3 | 30 days | EC forwards report + opinion on compensation to CLA |
| 4 | 60 days | Expert committee examines and recommends |
| 5 | 90 days | CLA decides quantum of compensation |
| 6 | 30 days | Sponsor pays compensation |
For PERMANENT DISABILITY/OTHER INJURY:
| Step | Timeline | Action |
|---|---|---|
| 1 | 14 days | Sponsor/investigator forward reports to CLA, EC, Head of Institution |
| 2 | 30 days | EC forwards report + opinion on compensation |
| 3 | 60 days | Expert committee recommends (if constituted) |
| 4 | 90 days | CLA decides quantum |
| 5 | 30 days | Sponsor pays compensation |
Rule 43: Biomedical & Health Research Compensation
- As per National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (ICMR)
CHAPTER VII: BA/BE STUDY CENTRE (Rules 44-51)
Rule 44: Registration Requirement
- NO BA/BE centre shall conduct study without registration from CLA
Rule 45: Application
- Form: CT-08
- Fee as per Sixth Schedule + documents as per Fourth Schedule
Rule 47: Grant of Registration
| Aspect | Details |
|---|---|
| Registration Form | CT-09 |
| Timeline | 90 working days |
| Validity | 5 years |
| Renewal | 90 days prior to expiry |
Rule 49: Conditions of Registration
- Must maintain facilities and qualified personnel as per Fourth Schedule
- Must have EC approval before initiating study
- Must inform CLA of EC approval
- Maintain records for 5 years after completion or 2 years after expiry of batch, whichever is later
CHAPTER VIII: MANUFACTURE OF NEW DRUGS/IND FOR CT/BA/BE (Rules 52-58)
⚠ MAJOR 2026 AMENDMENTS (GSR 46(E), 20 January 2026)
| Aspect | OLD (2019-2022) | NEW (2026) |
|---|---|---|
| Mechanism | Permission ONLY | "Permission OR Prior Intimation" |
| Timeline | 90 working days | 45 working days |
| Prior Intimation | Not applicable | Acknowledgment-based for analytical/non-clinical testing |
Rule 52 (Amended): Application for Manufacture Permission
- Form: CT-10
- For analytical and non-clinical testing: Prior Intimation route available
- Excluded from Prior Intimation (high-risk categories):
- Sex hormones
- Cytotoxic drugs
- Beta-lactam compounds
- Biologics with live microorganisms
- Narcotic/psychotropic substances
Rule 53 (Amended): Grant of Permission
| Aspect | Details |
|---|---|
| Approval Form | CT-11 |
| Timeline | 45 working days (reduced from 90) |
| Deemed Approval | If NO communication within 45 working days |
| Deemed Approval Form | CT-11A |
| Validity | 3 years |
| Extension | 1 year in exceptional circumstances |
Rule 54: Validity Period
- 3 years from date of issue
Rule 55: Conditions of Permission
- Use ONLY for CT/BA/BE/examination/test/analysis
- NO sale in market
- Manufacture in small quantities per GMP
- Maintain records
- Destroy unused/damaged/expired/substandard drugs
Rule 56: Licence under D&C Rules, 1945
- After obtaining CT-11 permission, apply for manufacturing licence under D&C Rules, 1945
CHAPTER IX: IMPORT OF NEW DRUGS/IND FOR CT/BA/BE (Rules 67-73)
Rule 67: Application for Import
- Form: CT-16
- Fee as per Sixth Schedule
Rule 68: Grant of Import Licence
| Aspect | Details |
|---|---|
| Licence Form | CT-17 |
| Timeline | 90 days |
| Validity | 3 years |
| Extension | 1 year in exceptional circumstances |
Rule 70: Conditions of Licence
- Manufactured per GMP
- Use ONLY for CT/BA/BE/examination/test/analysis
- NO sale in market
- Maintain records
- Destroy unused/damaged/expired/substandard drugs
CHAPTER X: IMPORT OR MANUFACTURE OF NEW DRUG FOR SALE/DISTRIBUTION (Rules 74-85)
Rule 75: Application for Import Permission
- Form: CT-18
- Fee as per Sixth Schedule
Rule 76: Grant of Import Permission
| Aspect | Details |
|---|---|
| API Permission | CT-19 |
| Formulation Permission | CT-20 |
| Timeline | 90 working days |
Rule 77: Conditions for Import
- Warning label: "To be sold by retail on the prescription of a Only" in RED BOX
- Submit Periodic Safety Update Reports (PSURs) as per Fifth Schedule
- Report all serious unexpected adverse reactions
- Specimen of carton/labels/package insert approved before marketing
Rule 80: Application for Manufacture Permission
- Form: CT-21
- Fee as per Sixth Schedule
- NO fee if Phase I-III CT completed in India and fee already paid
Rule 81: Grant of Manufacture Permission
| Aspect | Details |
|---|---|
| API Permission | CT-22 |
| Formulation Permission | CT-23 |
| Timeline | 90 working days |
Rule 82: Conditions for Manufacture
- Same as Rule 77 (red box warning, PSURs, etc.)
Rule 85: Responsibility of Importers/Manufacturers
- Market only for approved indication and dosage form
- NOT punishable for off-label use if manufacturer proves no involvement in promotion
CHAPTER XI: IMPORT/MANUFACTURE OF UNAPPROVED NEW DRUG FOR GOVERNMENT HOSPITAL (Rules 86-96)
Rule 86: Application by Government Hospital
- Form: CT-24
- For life-threatening disease/serious permanent disability/unmet medical needs
- Certified by Medical Superintendent/Head of Institution
Rule 87: Grant of Licence
- Form: CT-25
- Quantity limit: 100 average dosages per patient (extendable in exceptional circumstances)
- Validity: 3 years
Rule 91: Manufacture of Unapproved Drug Under CT for Life-Threatening Disease
- Form: CT-26 (application), CT-27 (permission)
- Patient consent required
- EC recommendation required
- Quantity limit: 100 average dosages per patient
CHAPTER VA: CLINICAL RESEARCH ORGANISATIONS (Rules 38A-38F)
Added by GSR 581(E), 19 September 2024; Effective from 1 April 2025
Rule 38A: CRO Registration Mandatory
- NO CRO shall conduct CT/BA/BE of new drug/IND without registration from CLA
Rule 38B: Application for CRO Registration
- Form: CT-07B
- Fee: ₹5,00,000
- Already registered BA/BE centres deemed registered for BA/BE purposes
Rule 38C: Grant of Registration
| Aspect | Details |
|---|---|
| Registration Form | CT-07C |
| Timeline | 45 working days |
| Validity | 5 years |
| Renewal | Form CT-07B, 90 days prior to expiry |
Rule 38D: Validity and Renewal
- 5 years validity
Rule 38E: Inspection of CRO
- CLA-authorized officer may inspect with/without notice
Rule 38F: Suspension/Cancellation
- Same provisions as other registrations
CHAPTER XIII: MISCELLANEOUS (Rules 98-107)
Rule 98: Pre-Submission Meeting
- Request in writing for guidance
- Fee as per Sixth Schedule
Rule 99: Post-Submission Meeting
- Within 15 days of receiving query
- Fee as per Sixth Schedule
Rule 100: Expert Committee
- CLA may constitute expert committees
- Recommendations within 60 days
Rule 101: Countries for Waiver of Local CT
| Aspect | Details |
|---|---|
| Policy | CLA may specify countries for considering waiver of local CT |
| Current List | US, UK, Japan, Australia, Canada, EU (EMA) |
Rule 102: Mode of Payment
| Aspect | Details |
|---|---|
| Method | Through challan or electronic mode |
| Bank | Bank of Baroda, Kasturba Gandhi Marg, New Delhi |
| Head of Account | "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines" |
Rule 103: Debarment
- For submitting misleading/fake/fabricated documents
- After show cause opportunity
Rule 104: Public Domain
- Orders of suspension/revocation/cancellation uploaded on CDSCO website
Rule 105: Digitalisation of Forms
- Forms may be modified for digital conversion without formal amendment
Rule 106: Applicability in Case of Inconsistency
- NDCT Rules prevail over other rules under D&C Act
Rule 107: Savings
- Prior approvals valid till expiry under corresponding provisions
FIRST SCHEDULE: GENERAL PRINCIPLES FOR CLINICAL TRIAL
Phase I-IV Clinical Trials
| Phase | Objective | Key Features |
|---|---|---|
| Phase I | Safety and tolerability; initial administration in humans | Non-therapeutic objectives; healthy subjects or certain patients; MTD; pharmacokinetics; pharmacodynamics |
| Phase II | Effectiveness for particular indication; common short-term side effects | Narrow criteria; homogeneous population; dose determination for Phase III |
| Phase III | Demonstration/confirmation of therapeutic benefits; marketing approval basis | Confirm safety and efficacy; wider populations; extended exposure |
| Phase IV | Post-marketing; additional drug-drug interactions; dose-response; safety studies | After approval; mortality/morbidity studies; epidemiological studies |
Special Populations
| Population | Requirement |
|---|---|
| Geriatrics | Include in Phase III (and Phase II optionally) if disease of aging, substantial geriatric population, or drug alters geriatric response |
| Paediatrics | Begin with older children → younger children → infants; for serious diseases, include early after initial safety data |
| Pregnant/Nursing Women | Only when drug intended for use by them; follow-up data on pregnancy, foetus, child required |
SECOND SCHEDULE: DATA REQUIREMENTS
Table 1: New Drug/NCE — Clinical Trial/Import/Manufacture
- Chemical and pharmaceutical information
- Animal pharmacology data
- Animal toxicology data
- Human clinical pharmacology (Phase I)
- Therapeutic exploratory trials (Phase II)
- Therapeutic confirmatory trials (Phase III)
- Special studies (bioavailability/bioequivalence, geriatrics, paediatrics, pregnant/nursing women)
- Regulatory status in other countries
- Prescribing information
- Samples and testing protocols
- Risk vs benefit assessment
- Copy of manufacturing licence (for manufacture application)
Table 2: Drug Already Approved in Country
- Chemical and pharmaceutical information
- Marketing information
- Special studies (bioavailability/bioequivalence for oral dosage forms)
Table 3: Approved Drug with New Claims
- Existing permission details
- Therapeutic justification
- Chemical and pharmaceutical information
- Animal pharmacological and toxicological data
- Clinical trial data
- Regulatory status
- Marketing information
Table 4: Phytopharmaceutical Drugs
- Botanical identity, authentication, source
- Process for extraction and fractionation
- Formulation details
- Stability data
- Safety and pharmacological information
- Human studies (Phase I for MTD)
- Confirmatory clinical trials
THIRD SCHEDULE: CONDUCT OF CLINICAL TRIAL
Table 1: EC Registration Information and Approval Format
Table 2: Protocol Contents
- Title page, background, study rationale, objectives, design, population, assessments, conduct, treatment, adverse events, ethical considerations, monitoring, data analysis, undertaking
Table 3: Informed Consent
Essential Elements:
- Statement that study involves research
- Expected duration
- Procedures to be followed
- Foreseeable risks/discomforts
- Expected benefits
- Alternative procedures/therapies
- Confidentiality of records
- Random assignment probability
- Financial compensation and medical management
- Contact person for queries
- Prorated payment
- Voluntary participation, right to withdraw
- Possibility of failure of investigational product
- Placebo statement (if applicable)
Audio-Video Recording:
- Mandatory for vulnerable subjects in CT of NCE/NME
- Audio only for anti-HIV and anti-leprosy drugs
Table 4: Investigator's Undertaking
- Review protocol, conduct per protocol, inform subjects, report adverse events, maintain records, cooperate with audits
Table 5: SAE Reporting Data Elements
- Patient details, suspected drug, other treatments, SAE details, outcome, investigator details
Table 6: Clinical Trial Report Structure
- Title page, synopsis, compliance statement, abbreviations, contents, ethics committee, study team, introduction, objectives, investigational plan, trial subjects, efficacy evaluation, safety evaluation, discussion, references, appendices
Table 7: Investigator's Brochure
- Summary, introduction, physical/chemical/pharmaceutical properties, non-clinical studies, effects in humans, summary and guidance
Table 8: Prescribing Information
- Generic name, composition, dosage form, clinical particulars, pharmacological properties, nonclinical properties, description, pharmaceutical particulars, patient counselling, manufacturer details, licence number, date of revision
FOURTH SCHEDULE: BA/BE STUDY REQUIREMENTS
BA/BE Centre Requirements:
- Legal identity
- Impartiality, confidentiality, independence, integrity
- Organisation and management (Investigator, CPU, analytical lab, data handling, QA)
- Documented SOPs
- Clinical Pharmacological Unit (minimum 16 volunteers)
- Facilities for: office, sample collection, storage, wet chemical lab, instrumental lab, library, documentation archival
Table 1: Documents for BA/BE Centre Registration
- Name and address
- Legal identity document
- Proprietors/partners/directors
- Organogram and CVs
- Impartiality documents
- Equipment list
- Staff list
- SOPs list
- Facility layout
- Ethics Committee details
- Retention samples facility
- Tie-ups for ancillary services
FIFTH SCHEDULE: POST MARKETING ASSESSMENT
PSUR Requirements:
| Reporting Period | Frequency | Submission Timeline |
|---|---|---|
| First 2 years | Every 6 months | Within 30 calendar days of last day of reporting period |
| Next 2 years | Annually | Within 30 calendar days of last day of reporting period |
| Serious unexpected adverse reactions | As needed | Within 15 days of occurrence |
SIXTH SCHEDULE: FEE STRUCTURE
| S.No. | Rule | Subject | Fee (₹) |
|---|---|---|---|
| 1 | 21 | CT Phase I | 3,00,000 |
| 2 | 21 | CT Phase II | 2,00,000 |
| 3 | 21 | CT Phase III | 2,00,000 |
| 4 | 21 | CT Phase IV | 2,00,000 |
| 5 | 22 | Reconsideration of CT | 50,000 |
| 6 | 33 | BA/BE Study | 2,00,000 |
| 7 | 34 | Reconsideration of BA/BE | 50,000 |
| 8 | 45 | BA/BE Centre Registration | 5,00,000 |
| 9 | 47 | Renewal of BA/BE Centre | 5,00,000 |
| 10 | 52 | Manufacture for CT/BA/BE | 5,000 per product |
| 11 | 53 | Reconsideration of manufacture | 2,000 per product |
| 12 | 59 | Unapproved API manufacture | 5,000 per product |
| 13 | 60 | Reconsideration of unapproved API | 2,000 per product |
| 14 | 67 | Import for CT/BA/BE | 5,000 per product |
| 15 | 68 | Reconsideration of import | 2,000 per product |
| 16 | 75 | Import new drug (formulation) | 5,00,000 |
| 17 | 75 | Import new drug (formulation) already approved | 2,00,000 |
| 18 | 75 | Import new drug (API) for marketing | 5,00,000 |
| 19 | 75 | Import new drug (API) already approved | 2,00,000 |
| 20 | 75 | New claims/new indication/new dosage form | 3,00,000 |
| 21 | 75 | Fixed Dose Combination | 4,00,000 |
| 22 | 80 | Manufacture new drug (formulation) | 5,00,000 |
| 23 | 80 | Manufacture new drug (API) | 5,00,000 |
| 24 | 86 | Import by Government hospital | As specified |
| 25 | 91 | Manufacture unapproved for life-threatening | As specified |
| 26 | 98 | Pre-submission meeting | 50,000 |
| 27 | 99 | Post-submission meeting | 25,000 |
| 28 | 38B | CRO Registration (2024) | 5,00,000 |
QUICK REVISION TABLES FOR EXAM
ALL FORMS AT A GLANCE
| Form | Purpose |
|---|---|
| CT-01 | EC Registration Application |
| CT-02 | EC Registration Certificate (Clinical Trial) |
| CT-02A | Deemed EC Registration |
| CT-03 | EC Final Registration (Biomedical Research) |
| CT-04 | CT Permission Application |
| CT-04A | Automatic Approval (India-discovered drug) |
| CT-05 | BA/BE Permission Application |
| CT-06 | CT Permission Grant |
| CT-06A | Deemed CT Approval |
| CT-07 | BA/BE Permission Grant |
| CT-07A | Deemed BA/BE Approval |
| CT-07B | CRO Registration Application (2024) |
| CT-07C | CRO Registration Certificate (2024) |
| CT-08 | BA/BE Centre Registration Application |
| CT-09 | BA/BE Centre Registration Certificate |
| CT-10 | Manufacture Permission Application (CT/BA/BE) |
| CT-11 | Manufacture Permission Grant (CT/BA/BE) |
| CT-11A | Deemed Manufacture Approval (CT/BA/BE) |
| CT-12 | Application to Manufacture Unapproved API for CT/BA/BE |
| CT-13 | Permission to Manufacture Unapproved API for CT/BA/BE |
| CT-14 | Application for Import Licence for IND (Non-clinical test/analysis) |
| CT-15 | Import Licence for IND (Non-clinical test/analysis) |
| CT-16 | Import Licence Application (CT/BA/BE) |
| CT-17 | Import Licence Grant (CT/BA/BE) |
| CT-18 | Import Permission Application (Sale/Distribution) |
| CT-19 | Import Permission Grant (API for Sale/Distribution) |
| CT-20 | Import Permission Grant (Formulation for Sale/Distribution) |
| CT-21 | Manufacture Permission Application (Sale/Distribution) |
| CT-22 | Manufacture Permission Grant (API for Sale/Distribution) |
| CT-23 | Manufacture Permission Grant (Formulation for Sale/Distribution) |
| CT-24 | Import/Manufacture Application (Govt. Hospital - Unapproved New Drug) |
| CT-25 | Import/Manufacture Licence Grant (Govt. Hospital - Unapproved New Drug) |
| CT-26 | Application to Manufacture Unapproved Drug (Life-threatening disease under CT) |
| CT-27 | Permission to Manufacture Unapproved Drug (Life-threatening disease under CT) |
| CT-28 | Application for Orphan Drug Designation |
| CT-29 | Orphan Drug Designation Certificate |
| CT-30 | Application for Waiver of Local CT |
| CT-31 | Waiver of Local CT Grant |
| CT-32 | Application for Post-Trial Access |
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