Pharmaceutical Business Management

Group 9

Harshida Yeole – 18 Snehal Singh – 55

Rahul Patil – 38 Dhanashree Teli – 57

Tejal Sharma - 48 Reena Yadav - 60

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 Current regulatory
requirements for new
drug approval and
clinical trial in
India – NDCT 2019
2
 Clinical Trials

Drugs and Cosmetics Rules, 1945

(D&C Rules)

Conducted in accordance with the

requirements set out in Schedule Y

3
 Amendments in D & C Act

Rule- 122 DAB Rule 122 DAC

3rd Amendment
Compensation to an Lists out the condition Guidelines in relation
affected clinical trial for the conduct of to composition and
subject in case of injury or clinical trial registration of ethics
death during clinical trial
committees

4
https://corporate.cyrilamarchandblogs.com/2019/07/new-drugs-clinical-trials-rules-2019-regulations-india/
New Drug and Clinical Trial
Rule - 2019
CHAPTER: 1 - Preliminary
RULE (2) - Definition

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“Clinical
“Clinical Trial”
Trial” in
in relation
relation toto aa new
new “Orphan
“Orphan drug”
drug” means
means aa drug
drug “Academic
“Academic Clinical
Clinical Trial”
Trial” means
means aa
drug
drug or or investigational
investigational new new drug
drug intended clinical
clinical trial
trial of
of aa drug
drug already
already
intended to
to treat
treat aa condition
condition which
which
means
means any any systematic
systematic study
study ofof such
such approved
approved for for aa certain
certain claim
claim and
and
new
new drugdrug or
or investigational
investigational newnew affects
affects not
not more
more than
than five
five lakh
lakh initiated
initiated by
by any
any investigator,
investigator,
drug
drug in in human
human subjects
subjects toto generate
generate persons academic
academic or or research
research institution
institution
persons in
in India
India
data
data forfor discovering
discovering or or verifying
verifying for
for aa new
new indication
indication or or new
new route
route
its,-
its,- of
of administration
administration or or new
new dose
dose or
or
(i)
(i) clinical
clinical or;
or; “Post-trial new
new dosage
dosage form,
form, where
where the the
“Post-trial access”
access” means
means making
making aa
(ii)
(ii) pharmacological
pharmacological including
including results
results of
of such
such aa trial
trial are
are intended
intended
pharmacodynamics,
pharmacodynamics, new
new drug
drug or
or investigational
investigational new
new to
to be
be used
used only
only for
for academic
academic or or
pharmacokinetics
pharmacokinetics or; or; drug research
research purposes
purposes and and not
not for
for
drug available
available to
to aa trial
trial subject
subject
(iii)
(iii) adverse
adverse effects,
effects, seeking
seeking approval
approval of of the
the Central
Central
with
with thethe objective
objective of of determining
determining during
during clinical
clinical trial,
trial, for
for such
such period
period Licensing
Licensing Authority
Authority or or regulatory
regulatory
the
the safety,
safety, efficacy
efficacy oror tolerance
tolerance of of as authority
authority ofof any
any country
country forfor
as considered
considered necessary
necessary by
by the
the
such
such newnew drug
drug oror investigational
investigational marketing
marketing or or commercial
commercial purpose
purpose
new
new drug.
drug. investigator
investigator and
and the
the Ethics
Ethics
Committee
Committee

https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf
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NEW DRUG Definition

1 2 3 4 5
A drug, including active A drug approved A fixed dose combination A vaccine,
A modified or
pharmaceutical of two or more drugs, recombinant
by the Central sustained release
ingredient or approved separately for Deoxyribonucleic
phytopharmaceutical Licencing form of a drug or Acid (r-DNA)
certain claims and
drug, which has not been Authority for proposed to be combined novel drug derived product,
used in the country to any certain claims and for the first time in a fixed delivery system living modified
significant extent, except proposed to be ratio, or where the ratio of of any drug organism,
in accordance with the marketed with ingredients in an approved by the monoclonal anti-
provisions of the Act and modified or new approved combination is Central body, stem cell
the rules made proposed to be changed derived product,
claims including Licencing
thereunder, as per with certain claims gene therapeutic
conditions specified in the indication, route of Authority; or product or
including indication, route
labelling thereof and has administration, of administration, dosage xenografts, intended
not been approved as safe dosage and and dosage form; or to be used as drug.
and efficacious by the dosage form; or
Central Licencing
Authority with respect to
its
claims; or

Explanation: The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission
granted by the Central Licencing Authority; and the drugs referred to in subclauses (iv) and (v) shall always be deemed to be new drugs

https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf 7
 CHAPTER : 5

Clinical trial, BA/BE Study of New

Drug & INDs

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RULE 21
Application for permission to conduct clinical trial of a
new drug or investigational new drug
Form CT-04 (instead of form 44) with revised application
fees.
(Centre /State Govt sponsored projects are exempted from
application fees)
Rule 22 (3) (ii)
Grant of permission to conduct clinical trial
In case of rejection, the applicant can request the
CLA to reconsider the application within a period of
60 working days from the date of rejection of the
application, on payment of fee
https://www.iscr.org/wp-content/uploads/2019/05/New-Rules-2019_ISCR-RC_21Apr2019_GMupdates-1.pdf
Rule 22 (2)
Grant of permission to conduct clinical trial
Decision on application will be taken within 90
working days
Rule 23
Permission to conduct clinical trial of a new drug or
IND as part of discovery, research & manufacture in
India
Application to conduct clinical trial will be approved if
no query is raised by CLA. The applicant will have to
notify in Form CT – 4A to CLA prior initiation of
clinical trial
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Rule 25 Conditions of permission for conduct of clinical
trial
ii) Clinical trial sites that do not have their own EC, can use registered EC of another
trial site or an independent EC, that is located within the same city or within a
radius of 50 kms of the clinical trial site.
vii) Status of enrolment of the trial subjects shall be submitted to the CLA on
quarterly basis
viii) Termination of clinical trial has to be notified within 30 days to the CLA
ix) In case of termination of any clinical trial the detailed reasons for such
termination shall be communicated to the Central Licencing Authority within 30
working days of such termination
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RULE 26 Rule 27
Validity period of permission to initiate a
Post Trial access of IND or new Drug
clinical trial
The permission to initiate clinical trial (under Post trial access of drug to patients is
completely at the discretion of the
Rule 22) in Form CT-06; or “automatic investigator and approval by EC- drug has
approval” (under Rule 23) in Form CT 4A, will to be provided free- of –cost by the
Sponsor
be valid for a period of 2 years from the date of
its issue.
Rule 28 Academic Clinical Trial

 No permission for conducting an academic clinical trial by CLA, if it is intended solely for academic
research purposes.
 Only EC approval is mandatory.
 Observations of such clinical trial should not be used for promotional purposes

https://www.iscr.org/wp-content/uploads/2019/05/New-Rules-2019_ISCR-RC_21Apr2019_GMupdates-1.pdf 11
Rule 31

BA/BE study can be carried out only after permission of CLA and protocol should be approved
by EC registered under Rule 8

Rule 33

Application to CLA with form CT- 05

Rule 34

Grant of application in form CT-07

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 CHAPTER : 9
Import of New Drugs & IND for Clinical
Trial BA/BE Study or for Examination Test
and Analysis

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Rule 67 Application of Import of new drug or investigational new drug

Grant of licence for import of new drug or Investigational new

Rule 68
drug
Validity period of licence for import of new drug for clinical trial or BA
Rule 69 /BE study for test and analysis

Rule 70 Condition of Licence

Rule 71 Inspection of imported new drug

Rule 72 Suspension or cancellation of import license of new drug

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New Labelling requirement
Relabelling or any
Where a drug is being
imported by the licence, on alteration of the IP
behalf of another
person(sponsor), the licence label would require
shall indicate on the label of approval from DCGI
the container the “name and
address of the importer”

Manner of Labelling Manner of labelling

Rule 73 (2) Rule 73 (3)

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 CHAPTER : 10
Import or Manufacture of New Drug for Sale
or for Distribution

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 Rule 75 - Application for permission to import new drug for sale or distribution

 For import of new drug in the form of API or pharmaceutical formulation for sale and

distribution in India should make an application to CLA in Form CT-18

 New drug with unapproved molecule

Application Form CT- 18
should be accompanied by
 New indication/New dosage form/
data and other particulars
New route of administration/ New strength
including results of local
 New drug which is a fixed dose combination
clinical trial

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Rule 75(7) - Application for permission to import new drug for sale or distribution

The local clinical trial may not be required to be submitted along with the application if:

(i) The new drug is approved and marketed in countries specified by the Central Licencing

Authority 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

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Rule 75(7) - Application for permission to import new drug for sale or distribution

(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

Rule 75
factor affecting (7)
pharmacokinetics and pharmacodynamics, safety and efficacy of the new

drug; and
Application for
(iv) The applicant has given an undertaking in writing to conduct Phase IV clinical trial to
permission to import
establish safety and effectiveness of such new drug as per design approved by the Central
new drug for sale or
Licencing Authority
distribution
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 Rule 80 - Application for permission to manufacture new drug for sale or
distribution
 For manufacture of new drug in the form of API or pharmaceutical formulation for sale and

distribution in India should make an application to CLA in Form CT-21

 New drug with unapproved molecule

Application Form CT- 21
should be accompanied by
 New indication/New dosage form/
data and other particulars
New route of administration/ New strength
including results of local
 New drug which is a fixed dose combination
clinical trial

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 FEES AND FORMS

Administratively, all the application and approval formats have undergone a

change. Some of them are : -
-Form CT04 – Clinical Trial Application Form (Replaces Form 44)
- Form CT 04 A- Automatic Approval Information to CDSCO
- Form CT 06 - Permission to Conduct CTs by CDSCO
- Form CT 16- Application to grant of License to Import of New Drug for
Clinical Trials (Replaces Form 12)

https://www.iscr.org/wp-content/uploads/2019/05/Summary-of-new-regulation-final-1.pdf 21
 FEES AND FORMS

A hiked fee structure has been implemented. Key ones being :

- 3 lakh INR (approx. 3800 Euro/4500 USD) for Phase I
- 2 lakh INR (aprox 2500 Euro/2900 USD) for Phase II, III, IV & BA/BE study
- 5 lakh INR (approx. 6500 Euro/7200 USD) for pre submission meeting
- 50,000 INR (approx. 650 Euro/720 USD) for post submission meeting
- 5 lakh INR (approx. 6500 Euro/7200 USD) for registration of BA / BE study centre
- 5 lakh INR (approx. 6500 Euro/7200 USD) for new drug permission / Finished
formulation or API [import]

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