KEY CHANGES IN RULES OF CLINICAL TRIALS

The new rule contains 13 chapters and 8 schedules and will be applicable to all new drugs, investigational new drugs for human use, clinical
trial, bioequivalence study, bioavailability study and ethics Committee. The new regulations clearly define features of an academic study, the
role of central licensing authority, trial protocol, biomedical and health research.

Chapters Name of the chapter Emphasis on

Chapter I Preliminary (Chapter 1) Definition of Clinical research & regulatory terms
Chapter II Authorities And Officers This Section gives information on the delegation of signing
power not below the rank of Assistant Drug controller
Chapter III Ethics Committee For Clinical Trial, Bioavailability And This section gives information on the following
Bioequivalence Study  Requirement of the EC
 Constitution of EC for clinical trial.
 Registration of EC relating to
clinical trial, bioavailability and bioequivalence
study
 Validity period , renewal of License & Functions of
EC
 Proceedings of Ethics Committee for clinical trial
 Maintenance of records by Ethics Committee for
clinical trial
 Suspension or cancellation of registration of EC for
clinical trial.
Chapter IV Registration of Ethics Committee For This section gives information on the following
Biomedical And Health Research  Requirement of the EC
 Constitution of Ethics Committee for biomedical and
health research
 Registration of Ethics Committee
related to biomedical and health research.
 Suspension or cancellation of registration of Ethics
 Committee for biomedical and health research

Chapter V Clinical Trial, Bioavailability And Bioequivalence Study This section divided in to two part A and Part B gives
Of New Drugs And Investigational New Drugs information on the following

PART A- CLINICAL TRIAL

 Clinical trial of new drug or investigational new
drug
 Oversight of clinical trial site
 Application for permission to conduct clinical trial
of a new drug or investigational new drug.
 Grant of permission to conduct clinical trial.
 Permission to conduct clinical trial of a new drug
or investigational new drug as part of discovery,
research and manufacture in India.
 Permission to conduct clinical trial of a new drug
already approved outside India
 Conditions of permission for conduct of clinical
trial
 Validity period of permission to initiate a clinical
trial
 Post-trial access of investigational new drug or new
drug.
 About Academic clinical trial
 Inspection of premises relating to clinical trial
 Suspension or cancellation of permission to conduct
clinical trial.

PART B-BIOAVAILABILITY AND BIOEQUIVALENCE

STUDY

 Bioavailability or bioequivalence study of new drug

or investigational new drug.
 Oversight of bioavailability or bioequivalence study
centre
 Application for permission to conduct bioavailability
or bioequivalence study.
 Grant of permission to conduct bioavailability or
 bioequivalence study.
 Conditions of permission for
conduct of bioavailability or bioequivalence study.
 Validity period of permission to
conduct bioavailability or bioequivalence
study
 Inspection of premises relating to bioavailability or
bioequivalence study.
 Suspension or cancellation of permission to conduct
bioavailability or bioequivalence study
Chapter VI Compensation This section gives information on Compensation in case of
injury or death in clinical trial or bioavailability or
bioequivalence study of new drug or investigational new
drug.
Chapter VII Bioavailability And Bioequivalence Study Centre This section gives information on the following
 Registration of bioavailability and bioequivalence
study centre
 Application for registration of bioavailability and
bioequivalence study centre.
 Inspection of bioavailability and bioequivalence study
centre
 Grant of registration to
bioavailability and bioequivalence study centre.
 Validity period and renewal of registration of
bioavailability and bioequivalence centre
 Conditions of registration
 Inspection of bioequivalence and bioavailability study
centre registered with Central Licencing Authority.
 Suspension or cancellation of
registration of bioavailability and
bioequivalence study centre.
Chapter VIII Manufacture Of New Drugs Or Investigational New Drugs For This section gives information on the following
Clinical Trial, Bioavailability Or Bioequivalence Study Or For (1)Application for permission to manufacture of new drug or
Examination, Test And Analysis investigational new drug for clinical trial or bioavailability and
bioequivalence study or for examination, test and analysis

 Grant of permission to manufacture new drugs or

investigational new drugs for clinical trial or
bioavailability or bioequivalence study, or for
examination, test and analysis.
 Validity period, Conditions of permission
  License to manufacture new drugs or investigational
new drugs for clinical trial or bioavailability or
bioequivalence study or for examination, test and
analysis
 Details on Inspection and Suspension of the said
license

(2)Application for permission to manufacture unapproved active

pharmaceutical ingredient for development of pharmaceutical
formulation for test or analysis or clinical trial or bioavailability
and bioequivalence study
 Grant of permission to manufacture unapproved
active pharmaceutical ingredient for development of
pharmaceutical formulation for test or analysis or
clinical trial or bioavailability and bioequivalence
study
 Validity period, Suspension, Conditions of permission
 License to manufacture unapproved active
pharmaceutical ingredient for development of
formulation for test or analysis or clinical trial or
bioavailability and bioequivalence study
 Inspection of manufacturer of unapproved active
pharmaceutical ingredient for development of
formulation for test or analysis or clinical trial or
bioavailability and bioequivalence study
 Manner of labelling

Chapter IX Import Of New Drugs And Investigational New Drugs For This section gives information on the following
Clinical Trial Or Bioavailability Or Bioequivalance Study Or  Application for import of new drug
For Examination, Test And Analysis  Grant of licence for import of new drug
 Validity period of licence for import of new drugs
 Condition of licence
 Inspection of imported new drug for clinical trial or
the bioavailability or bioequivalence study
 Suspension or cancellation of import licence of new
drug for clinical trial or bioavailability or
bioequivalence study or for examination, test and
analysis
 Manner of Labelling

Chapter X Import Or Manufacture Of New Drug For Sale Or For This section gives information on the following
Distribution
  Regulation of new drug

(1)Application for permission to import new drug for sale or

distribution.
 Grant of permission for import of new drugs for sale
or distribution
 Condition of permission for import of new drugs for
sale or distribution
 Suspension or cancellation of import permission for
new drug
 License to import new drug for sale or for
distribution
(2)Application for permission to manufacture new drug for
sale or distribution.
 Grant of permission for manufacture of new drug for
sale or distribution
 Condition of permission for manufacture of new
drugs for sale or distribution
 Licence to manufacture a new drug for sale or for
distribution
 Suspension or cancellation of permission
 Responsibility of importers or manufacturers in
marketing of new drugs
Chapter XI Import Or Manufacture Of Unapproved New Drug For This section gives information on the following
Treatment Of Patients In Government Hospital And
Government Medical Institution
(1)Application for import of unapproved new drug by
Government hospital and Government medical institution
 Grant of license for import of unapproved new drug
by Government hospital and medical institution
 Conditions of licence
 Suspension or cancellation of import licence
 Inspection of unapproved new drug imported

(2)Application for permission to manufacture unapproved new

drug but under clinical trial, for treatment of patient of life
threatening disease
 Grant of permission to manufacture unapproved new
drug but under clinical trial,
  Condition of permission
 Inspection of unapproved new drug but under
clinical trial
 Suspension or cancellation of
permission to manufacture unapproved
new drug
 Licence to manufacture an unapproved new drug but
under clinical trial,
Chapter XII AMENDEMENTS OF DRUGS AND COSMETICS This section gives information on the following and new rule is
RULES, 1945 inserted

In the Drugs and Cosmetics Rules 1945, after rule 122DA the
following new rule shall be inserted, namely:_

“122DAA. Non-application of certain rules for new drugs and

investigational new drugs forhuman use.- Part XA and Schedule
Y shall not be applicable in respect of new drugs and investigational
new drugs for human use from the date of coming into force of the
New Drugs and Clinical Trials Rules, 2019, and the references in
respect of human use made in the these rules shall respectively be
omitted, and the construction thereof shall be construed accordingly
and shall stand amended with all cogent meaning of the grammar”.
Chapter XIII Miscellaneous This section gives information on the following
 Pre-submission meeting
 Post-submission meeting
 Constitution of expert committee or group of experts
by Central Licensing Authority
 Name of countries for purpose of new drug approval.
 Mode of payment of fee
 Debarment of applicant
 Order of suspension or revocation in public domain
 Digitalization of Forms
 Applicability in case of inconsistency
 Savings
DIFFERENT SCHEDULES

SR. SCHEDULE MENTIONS ON

NO.
1. FIRST SCHEDULE General principles and practices for clinical trial and contains the following
 General Principles
 Approach in design and analysis
 Development Methodology
 Phases in CT
 Studies in special population
 Conduct of CT, Its analysis and reporting
2. SECOND SCHEDULE Requirements and guidelines for permission to import or
manufacture of new drug for sale or to undertake clinical trial and contains the following
 Application for permission
 Special situations for a new drug where relaxation, abbreviations, omission or deferment of
data may be considered.
 Accelerated Approval Process
 Situations where quick or expeditious review process can be sought for approval of a new drug
after clinical development
 Requirements of data and information for permission to import or manufacture of a drug
already approved which is now proposed to be clinically tried or marketed with certain new
claims
 Animal toxicology and other studies
 Animal Pharmacology
 Fixed Dose Combinations (FDCs).
 Stability Testing of New Drugs
 Checklist of data required for application for New Drug
3. THIRD SCHEDULE Specifies on Conduct of clinical trial; and it contains the following
Conduct of clinical trial.-
Informed Consent.
Responsibilities of
sponsor / Investigator
and EC
 Information to
be submitted by
applicants for
registration of
EC
 contents of the
proposed
protocol for
conducting
  Prescribing Information
4. FOURTH SCHEDULE Requirements and guidelines for conduct of bioavailability
and bioequivalence study of new drugs or investigational new drugs and contains the following
 General Principles
 Bioavailability and bioequivalence study centre
 Organization and management
 Documented Standard Operating Procedures
 Clinical Pharmacological Unit
 Maintenance of Records
 Retention of Samples
 Checklist Of Document Required For Registration Of Bioavailability And Bioequivalence
Centre
 Checklist Of Document Required for approval of BE study
5. FIFTH SCHEDULE Post marketing requirements.
The section contains the following
 Post marketing assessment of new drug
 Phase IV (Post marketing) trial
 Post marketing surveillance study or observational or non-interventional study for active
surveillance
 Post marketing surveillance through periodic safety update reports.-
 PSUR structure and requirements

6. SIXTH SCHEDULE Fee payable for License, Permission and Registration certificate

7. SEVENTH SCHEDULE Formulae to determine the quantum of compensation in thebcases of clinical trial related injury or death

8. EIGHTS SCHEDULE Mentions on all the new forms required for application and format of license/permission
 Important changes
CT WAIVER CRITERIA

The local clinical trial may not be required to be submitted along with the
application referred to in sub-rule
(1) if,_

(i) the new drug is approved and marketed in countries specified by the Central Licencing Authority under rule 101 and if no major unexpected
serious adverse events have been reported; or

(ii) the application is for import of a new drug for which the Central Licencing Authority had already granted permission to conduct a global clinical
trial which is ongoing in India and in the meantime such new drug has been approved for marketing in a country specified under rule 101; and

(iii)there is no probability or evidence, on the basis of existing knowledge, of difference in Indian population of the enzymes or gene involved in the
metabolism of the new drug or any factor affecting pharmacokinetics and pharmacodynamics, safety and efficacy of the new drug; and

(iv)the applicant has given an undertaking in writing to conduct Phase IV clinical trial to establish safety and effectiveness of such new drug as per
design approved by the Central Licencing Authority:

Provided that the Central Licencing Authority may relax this condition, where the drug is indicated in life threatening or serious diseases or
diseases of special relevance to Indian health scenario or for a condition which is unmet need in India such as XDR tuberculosis, hepatitis C, H1N1,
dengue, malaria, HIV, or for the rare diseases for which drugs are not available or available at a high cost or if it is an orphan drug.

General:
Effective from 19 Mar 2019

Academic studies- data/results not to be used for regulatory submission or promotion

Orphan drug- affects not more than 5 lakh population, No fee to be paid for Orphan drugs.

 Post-submission meeting.- If the applicant desires to seek clarification in person in respect of pending application and queries related
thereto, the applicant may make an application for a post-submission meeting with the officer designated by the Central Licencing
Authority within a period of fifteen days from the date the query was received for seeking guidance with regards to the queries
concerning pending application, Fee 50 Thousand

 Pre-submission meeting.- Any person intends to make an application for grant of license or permission for import or manufacture of
new drugs or to conduct clinical trial may, request by making an application in writing, for a pre-submission meeting with the Central
Licencing Authority Fee 5 lacs
  As per the new rules the Drugs Controller General of India (DCGI), with the prior approval of the central government, can delegate all
or any of the powers of the Central Licensing Authority (CLA) to any other Officer of the Central Drugs Standard Control
Organization (CDSCO) not below the rank of Assistant Drugs Controller (ADC).

 Debarment of applicant.-Whoever himself or, any other person on his behalf, or applicant is found to be guilty of submitting
misleading, or fake, or fabricated documents, may, after giving him an opportunity to show cause as to why such an order should not be
made, in writing, stating the reasons thereof, be debarred by the Central Licencing Authority for such period as deemed fit.\

DIFFERENT FORMS-Eighth Schedule

SR. NO. FORMS MENTIONS ON

1. FORM CT-01 APPLICATION FOR REGISTRATION OF ETHICS COMMITTEE RELATING TO
CLINICAL TRIAL OR BIOAVAILABILITY AND BIOEQUIVALNENCE STUDY OR
BIOMEDICAL HEALTH RESEARCH
2. FORM CT-02 GRANT OF REGISTRATION OF ETHICS COMMITTEE RELATING
TO CLINICAL TRIAL OR BIOAVAILABILITY AND
BIOEQUIVALNENCE STUDY
3. FORM CT-03 GRANT OF REGISTRATION OF ETHICS
COMMITTEE RELATING TO BIOMEDICAL HEALTH
RESEARCH
4. FORM CT-04 APPLICATION FOR GRANT OF PERMISSION TO CONDUCT CLINICAL TRIAL OF
NEW DRUG OR INVESTIGATIONAL NEW DRUG
5. FORM CT-4A INFORMATION TO INITIATE CLINICAL TRIAL OF NEW DRUG OR
INVESTIGATIONAL NEW DRUG
6. FORM CT-05 APPLICATION FOR GRANT OF PERMISSION TO CONDUCT BIOAVAILABILITY OR
BIOEQUIVALENCE STUDY
7. FORM CT-06 PERMISSION TO CONDUCT CLINICAL TRIAL OF NEW DRUG OR
INVESTIGATIONAL NEW DRUG
8. FORM CT-07 PERMISSION CONDUCT BIOAVAILABILITY OR
TO NEW DRUG OR INVESTIGATIONAL
BIOEQUIVALENCE STUDYOF
NEW DRUG
9. FORM CT-08 APPLICATION FOR REGISTRATION OF
BIOAVAILABILITYOR BIOEQUIVALENCE STUDY CENTRE
10. FORM CT-09 GRANT OF REGISTRATION OF BIOAVAILABILITY OR
BIOEQUIVALENCE STUDY CENTRE
11. FORM CT-10 APPLICATION TO MANUFACTURE NEW DRUG OR INVESTIGATIONAL NEW DRUG
FOR CLINICAL TRIAL OR BIOAVAILABILITY OR BIOEQUIVALENCE STUDY OR
FOR EXAMINATION, TEST AND ANALYSIS
12. FORM CT-11 PERMISSION TO MANUFACTURE NEW DRUG OR INVESTIGATIONAL NEW DRUG
FOR CLINICAL TRIAL, BIOAVAILABILITY OR BIOEQUIVALENCE STUDY OR FOR
EXAMINATION, TEST AND ANALYSIS
13. FORM CT-12 APPLICATION FOR GRANT OF PERMISSIONTO MANUFACTURE FORMULATION
OF UNAPPROVED ACTIVE PHARMACEUTICAL INGREDIENT FOR TEST OR
ANALYSIS OR CLINICAL TRIAL OR BIOAVAILABILITY OR BIOEQUIVALENCE
STUDY
14. FORM CT-13 APPLICATION FOR GRANT OF PERMISSIONTO MANUFACTURE UNAPPROVED
ACTIVE PHARMACEUTICAL INGREDIENT FOR DEVELOPMENT OF
FORMULATION FOR TEST OR ANALYSIS OR CLINICAL TRIAL OR
BIOAVAILABILITY OR BIOEQUIVALENCE STUDY
15. FORM CT-14 PERMISSION TO MANUFACTURE FORMULATION OF UNAPPROVED ACTIVE
PHARMACEUTICAL INGREDIENT FOR TEST OR ANALYSIS OR CLINICAL TRIAL
OR BIOAVAILABILITY OR BIOEQUIVALENCE STUDY
16. FORM CT-15 PERMISSION TO MANUFACTURE UNAPPROVED ACTIVE PHARMACEUTICAL
INGREDIENT FOR THE DEVELOPEMNT OF FORMULATION FOR TEST OR
ANALYSIS OR CLINICAL TRIAL OR CLINICAL TRIAL OR BIOAVAILABILITY OR
BIOEQUIVALENCE STUDY
17. FORM CT-16 APPLICATION FOR GRANT OF LICENCE TO IMPORT NEW DRUG OR
INVESTIGATIONAL NEW DRUG FOR CLINICAL TRIAL OR BIOAVAILABILITY OR
BIOEQUIVALENCE STUDY OR FOR EXAMINATION, TEST AND ANALYSIS
18. FORM CT-17 LICENCE TO IMPORT NEW DRUG OR INVESTIGATIONAL NEW DRUG FOR
THE PURPOSE OF CLINICAL TRIAL OR BIOAVAILABILITY
OR BIOEQUIVALENCE STUDY OR FOR EXAMINATION, TEST AND
ANALYSIS
19. FORM CT- 18 APPLICATION FOR GRANT OF PERMISSION TO IMPORT NEW DRUG FOR SALE
OR FOR DISTRIBUTION
20. FORM CT-19 PERMISSION TO IMPORT NEW ACTIVE PHARMCEUTICAL INGREDIENT FOR
SALE OR FOR DISTRIBUTION
21. FORM CT-20 PERMISSION TO IMPORT PHARMACEUTICAL FORMULATIONS OF NEW DRUG
FOR SALE OR FOR DISTRIBUTION
22. FORM CT-21 APPLICATION FOR GRANT OF PERMISSION TO
MANUFACTURE NEW DRUG FOR SALE OR DISTRIBUTION
23. FORM CT-22 PERMISSION TO MANUFACTURE ACTIVE PHARMACEUTICAL INGREDIENT FOR
SALE OR DISTRIBUTION
24. FORM CT-23 PERMISSION TO MANUFACTURE PHARMACEUTICAL FORMULATION
OF NEW DRUG FOR SALE OR FOR DISTRIBUTION
25. FORM CT-24 APPLICATION FOR LICENCE TO IMPORT OF UNAPPROVED NEW DRUG FOR
TREATMENT OF PATIENTS OF LIFE THREATENING DISEASE IN A GOVERNMENT
HOSPITAL OR GOVERNMENT MEDICAL INSTITUTION
26. FORM CT-25 LICENCE TO IMPORT UNAPPROVED NEW DRUGFOR TREATMENT
OF PATIENTS OF LIFE THREATENING DISEASE IN A GOVERNMENT HOSPITAL
OR MEDICAL INSTITUTION
27. FORM CT-26 APPLICATION FOR GRANT OF PERMISSION TO MANUFACTURE UNAPPROVED
NEW DRUG BUT UNDER CLINICAL TRIAL FOR TREATMENT OF PATIENTS OF
LIFETHREATENING DISEASE IN A GOVERNMENT HOSPITAL OR MEDICAL
INSTITUTION
28. FORM CT-27 PERMISSION TO MANUFACTURE UNAPPROVED NEW DRUG BUT UNDER
CLINICAL TRIAL FOR TREATMENT OF PATIENTS OF LIFE THREATENING
DISEASE IN A GOVERNMENT HOSPITAL OR MEDICAL INSTITUTION
 Form CT rules 2019 - Eighth Schedule (relevant sections)
Sr. No. Matter/Application Previous Curent Previous Permission Current
Application form application Form obtained as permission Form

1 APPLICATION FOR GRANT OF PERMISSION TO CONDUCT CLINICAL Form 44 Form CT 04 Form CT NOC Form CT -06
TRIAL OF NEW DRUG OR INVESTIGATIONAL NEW DRUG Phase III- 2 lacs (2 years validity)
2 INFORMATION TO INITIATE CLINICAL TRIAL OF NEW DRUG OR New Adddition Form CT -4A New Adddition Form CT -06
INVESTIGATIONAL NEW DRUG AS PART OF DISCOVERY, RESEARCH (2 years validity)
AND MANUFACTURE IN INDIA
3 APPLICATION FOR GRANT OF PERMISSION TO CONDUCT Form 44 Form CT-05 BE NOC Form CT-07
BIOAVAILABILITY OR BIOEQUIVALENCE STUDY BE study-2 lacs (1 year validity)
4 APPLICATION TO MANUFACTURE NEW DRUG OR INVESTIGATIONAL New Adddition Form CT-10 New Adddition Form CT 11
NEW DRUG FOR CLINICAL TRIAL OR BIOAVAILABILITY OR Rs 5000 per Validity of CT 11
BIOEQUIVALENCE STUDY OR FOR EXAMINATION, TEST AND ANALYSIS product (3 years
Validity)
5 APPLICATION FOR GRANT OF PERMISSION TO MANUFACTURE New Addition CT-12 New adddition Form CT 14
FORMULATION OF UNAPPROVED ACTIVE PHARMACEUTICAL Rs 5000 per (3 years validity)
INGREDIENT FOR TEST OR ANALYSIS OR CLINICAL TRIAL OR product
BIOAVAILABILITY OR BIOEQUIVALENCE STUDY
6 APPLICATION FOR GRANT OF PERMISSION TO MANUFACTURE New Addition Form CT-13 New adddition Form CT 15
UNAPPROVED ACTIVE PHARMACEUTICAL INGREDIENT FOR Rs 5000 per (3 years validity)
DEVELOPMENT OF FORMULATION FOR TEST OR ANALYSIS OR product
CLINICAL TRIAL OR BIOAVAILABILITY OR BIOEQUIVALENCE STUDY
7 APPLICATION FOR GRANT OF LICENCE TO IMPORT NEW DRUG OR New Addition Form CT-16 New Addition Form CT-17
INVESTIGATIONAL NEW DRUG FOR CLINICAL TRIAL OR Rs 5000 per (3 years validity)
BIOAVAILABILITY OR BIOEQUIVALENCE STUDY OR FOR product
EXAMINATION, TEST AND ANALYSIS
8 APPLICATION FOR GRANT OF PERMISSION TO IMPORT NEW DRUG FOR Form 44 Form CT -18 Form 45 A (Bulk) Form CT 19
SALE OR FOR DISTRIBUTION (Bulk) (Fee 5 lacs)
9 PERMISSION TO IMPORT PHARMACEUTICAL FORMULATIONS OF NEW Form 44 Form CT -18 Form 45 Form CT 20
DRUG FOR SALE OR FOR DISTRIBUTION (Formulation)
10 APPLICATION FOR GRANT OF PERMISSION TO MANUFACTURE NEW Form 44 Form CT -21 Form 46 A(Bulk) Form CT 22
DRUG FORMULATION FOR SALE OR FOR DISTRIBUTION (Fee 5 lacs)
11 PERMISSION TO MANUFACTURE PHARMACEUTICAL FORMULATION OF Form 44 Form CT -21 Form 46 Form CT 23
NEW DRUG FOR SALE OR FOR DISTRIBUTION (Formulation)
 Form CT rules 2019 - Eighth Schedule (Other sections)
Sr. No. Matter/Application Previous Curent application Previous Permission Current
Application form Form obtained as permission Form

1 APPLICATION FOR REGISTRATION/RENEWAL OF ETHICS Application for Form CT 01 EC Registration Form CT -02
COMMITTEE RELATING TO CLINICAL registration of EC Certificate
TRIAL OR BIOAVAILABILITY AND BIOEQUIVALNENCE
STUDY OR BIOMEDICAL HEALTH
RESEARCH

2 APPLICATION FOR REGISTRATION/RENEWAL OF ETHICS New Adddition Form CT 01 New Adddition Form CT -
COMMITTEE RELATING TO CLINICAL TRIAL OR 03(Permisison for
BIOAVAILABILITY AND BIOEQUIVALNENCE STUDY OR Registyration of
BIOMEDICAL HEALTH RESEARCH EC forBiomedical
research)

3 APPLICATION FOR REGISTRATION/RENEWAL OF Application for Form CT-08 BE study centre Form CT-09
BIOAVAILABILITY OR BIOEQUIVALENCE STUDY registration of BE Registration
CENTRE study centre
4 APPLICATION FOR LICENCE TO IMPORT OF UNAPPROVED Form 12AA Form CT-24 Form 11 A Form CT 25
NEW DRUG FOR TREATMENT OF PATIENTS OF LIFE
THREATENING DISEASE IN A GOVERNMENT HOSPITAL OR
GOVERNMENT
MEDICAL INSTITUTION
5 APPLICATION FOR GRANT OF PERMISSION TO New Addition CT-26 New adddition Form CT 27
MANUFACTURE UNAPPROVED NEW DRUG BUT UNDER
CLINICAL TRIAL FOR TREATMENT OF PATIENTS OF LIFE
THREATENING DISEASE IN A
GOVERNMENT HOSPITAL OR MEDICAL INSTITUTION