New Drugs_CT Rules: A Glance

1. Clinical Trial studies For New Drugs –
New Drugs and Clinical Trials Rules, 2019
sponsor Investigator Ethics Committee Clinical trial site

2. SPONSOR TO COORIDNATE FOR
CLINICAL TRIALS
Sponsor
Ethics
Committee
(EC)
Investigator &
clinical trial site
cGMP site to
manufacture
IND
Central
Licencing
Authority (CLA)

3. •Clinical Trial studies
SPONSOR TO submit clinical trial protocol and documents to ethics committee (EC) TO CONDUCT clinical trial
Apply CT-04 or
CT-04A to CLA for
new drugs/IND
Permission granted in
CT-06 Or by Auto-
approval in CT-04A
(Valid for 2 years)
Deficiencies /
Queries
Approved
Queried or
Rejected
APPROVED REJECTED
Within 90 or 30
Days, respectively
Rectify
Deficiencies
CLA Re- Review
once
Submit Protocol and documents To
Ethics Committee (EC)
[EC at the trial site or another trial site within 50
km from site or an independent EC]
Inform CLA within 15
working days of
approval
Approved
or Rejected
APPROVED REJECTED
Register the Trial
in Clinical Trial
Registry of ICMR
Before enrolling
first subject.
Inform CLA before seeking
approval of another Ethics
Committee
Ethics committee should be
registered with Central Drug
Licensing Authority (CLA)
before submission of Clinical
Trial Protocol
Apply for
Permission to
manufacture New
drug in CT-10 or
Unapproved New
Drug in CT-12 and
CT-13, to CLA
Laboratories Used
for Clinical Trial
studies should be
registered with
CLA
Further

4. APPLICATIONS FROM SPONSOR TO CENTRAL LICENSING AUTHORITY (CLA) and Ethics committee TO CONDUCT clinical trial
Approved
Queried or
Rejected
Apply to CLA, for new drugs/IND
discovered, to be manufactured and
marketed in India
Permission granted in CT-06 or
Automatic approval
(Valid for 2 years)
Within 30 Days
Submit Protocol and documents To Ethics
Committee (EC)
[EC at the trial site or another trial site within 50 km
from site or an independent EC]
Approved or
Rejected
Inform CLA within 15 working days of EC approval o
OR
Inform CLA before seeking approval of another Ethics
Committee
Note: CT-04 A is the application for clinical trial using IND discovered in India.
- It is mandatory to fill-up the details of Ethics committee in the application (as per 2019 guidelines).
- Ethics committee approval should be notified to Central Licensing authority.
- So, Clinical protocol and documents to be submitted to EC, first. Then CT-04 A can be applied. [or]
- Can be applied in parallel, provided EC is finalized and awaiting only EC approval. After approval, to be notified to CLA.
SUGAM Portal to be verified to confirm on the possibilities.

5. APPLICATIONS TO CENTRAL LICENSING AUTHORITY (CLA) TO manufacture new drug or investigational new drug for clinical
trial
• Note: If Rejected after addressing queries, Sponsor to request CLA
within 60 working days from Date of Rejection (or)
• Appeal to Central Govt Ministry of Health & Family welfare within 45
days from Date of Rejection.
• Govt hears and disposes appeal within 60 working days from date of
appeal.
• Note: New Drugs are of two types – Approved and Unapproved.
• Approved is Regulatory Approved outside India and declared as New Drug for import, sale
and distribution in India. Such drugs after completion of four years after approval,
designated as old drugs.
• Unapproved New Drugs are New drugs that are not approved both in India and outside
India
• Manufacturer of pharmaceutical formulation to apply in Form CT-12 and manufacturer of the
active pharmaceutical ingredient to apply in Form CT-13.
Apply CT-10 to CLA to
manufacture new
drugs/IND for examination,
test and analysis
Permission granted
in CT-11
(Valid for 3 years)
Deficiencies /
Queries, if rectifiable
Approved
Queried or
Rejected
APPROVED REJECTED
Within 90 Days
Rectify
Deficiencies
CLA Re- Review
once
Apply CT-12 and CT-13 to CLA, to manufacture
new drugs/IND with unapproved Active
Pharmaceutical Ingredient for examination,
test and analysis
Permission granted
in CT-14 and CT-15
(Valid for 3 years)
Approved
Queried or
Rejected
APPROVED REJECTED
Within 90 Days
Rectify
Deficiencies
CLA Re- Review
once
Deficiencies /
Queries, if rectifiable
Documents as per Second
schedule and
fees as per Sixth schedule (Appln
– Rs.5000/-, if applied for
reconsideration – Rs.2000/-)

6. APPLICATIONS TO CENTRAL LICENSING AUTHORITY (CLA) TO CONDUCT manufacture new drug or investigational new drug
for clinical trial
Apply CT-12 to to CLA, to manufacture new drugs/IND
Formulations using unapproved Active Pharmaceutical
Ingredient for examination, test and analysis
Permission granted in
CT-14
(Valid for 3 years)
Approved
Queried or
Rejected
Within 90 Days
Apply CT-13 to CLA, to manufacture new drugs/IND
with unapproved Active Pharmaceutical
Ingredient for examination, test and analysis
Approved
Queried or
Rejected
Within 90 Days
Permission granted in
CT-15
(Valid for 3 years)
Note: New Drugs are of two types – Approved and Unapproved.
Approved is Regulatory Approved outside India and declared as New Drug for import, sale and distribution in India. Such
drugs after completion of four years after approval, designated as old drugs.
Unapproved New Drugs are New drugs that are not approved both in India and outside India
Manufacturer of pharmaceutical formulation to apply in Form CT-12 and manufacturer of the active pharmaceutical ingredient
to apply in Form CT-13.

7. • Ethics Committee to approve the Clinical Trial protocol
• CT-04A shall be applied to conduct clinical trial for a new drug invented in India
• CT-04/CT-04A and CT-12 / 13 can be applied in parallel.
• CT-12 application is for manufacturing a drug Formulation using Unapproved New drug for
clinical trial.
• CT-12 should be applied with Non-clinical and CMC data.
• CT-13 application is for manufacturing an Unapproved New drug (API), for using in clinical
trial.
Conclusions