The document discusses the regulatory process for clinical trials in India. It outlines that clinical trials are regulated by Schedule Y of the Drugs and Cosmetics Rules, 1945, which is governed by CDSCO. The application process involves obtaining approval from the DCGI and an IEC/IRB, and submitting Form 44 along with relevant documents. Recent reforms by CDSCO include fast-tracking the approval timeline to 30 days for complete applications, providing single-window clearance for export NOCs within 10 days, and mandating registration with CTRI to increase accountability and transparency.

1. Clinical Trial applications in
India

2. Flow of topics:
• Drug and cosmetic act, 1945 & Schedule Y
• Regulatory Requirement for clinical trial
• Flow of application for clinical trial
• Form 44 for clinical trial application
• Recent regulatory reforms initiated by CDSCO
– Fast-tracking approval timelines:
– Single-window clearance for export No Objection
Certificate (NOC)
– Mandatory registration with Clinical Trials Registry-
India (CTRI

3. Drug and Cosmetic Act, 1945 &
Schedule Y
• The history of various regulatory aspects
related to drug import, manufacture and sale
are covered under the Drugs & Cosmetics Act
of 1940 and Drugs & Cosmetics Rules of 1945.
• The Act’s main objective is to ensure that
available human drugs are safe and efficacious
and conform to prescribed quality standards,
and marketed cosmetics are safe for use.

4. Cont…
• Currently clinical trials in India are regulated
by Schedule Y of the Drug and Cosmetics
Rules, 1945.
• Schedule Y defines the requirements and
guidelines for import and/or manufacture of
new drugs for sale or for clinical trials which is
governed by CDSCO(Central Drug Standard
Control Organisation).

5. Regulatory requirement for clinical
trial:
• Regulatory Body for clinical Trial:
• Regulatory processes are being harmonized
with US and international standards.
• Drugs Controller General of India(DCGI) has
the prominent role in overseeing clinical trial
in India along with Ethics committee(IEC/IRB:
Institutional Ethical Committee/Institutional
Review Board).

6. Cont…
• Apart from DCGI, different agencies such as
Department of Biotechnology (DBT), Indian
Council of Medical Research (ICMR), Central
Bureau of Narcotics (CBN), Review Committee
on Genetic Manipulation (RCGM) and Genetic
Engineering Approval Committee (GEAC) are
also involved in clinical research regulation in
India.

7. Flow of Application for
Clinical Trial

8. DCGI
• Primary permission for clinical trial
• Importing drug for clinical trial
• Sponsor should provide all data
regarding drug molecule
• Applicant has to submit all
Suspected or Unexpected Serious
Adverse Reactions (SUSAR) if any.
• Sponsor has to submit affidavit
stating that study has not been
discontinued in any country(If any
reason should be provided)
• approval time of application in
India is 10-12 wks.

9. IEC/IRB
• For the BA/BE study, the regulatory
requirement for the study depends
upon the study drug molecule.
• If the study drug molecule is old drug,
then approval from the DCG(I) won’t
be required and only the approval
from the EC committee will suffice.
• In case of BA/BE study for new drug,
the anticipated timelines for DCG(I)
approval would be 6-8 weeks.
• Approval process is conducted in
parallel with DCGI.

10. Form 44 for CT application:
• Application for permission to initiate specific phase
of clinical trial sponsor is required to submit
application (Form 44 and Appendix-01) for the
purpose of conducting clinical trial in India and
submit documents as per Schedule Y of the Drugs
and Cosmetics Act 1940 and Rules.

11. Cont…
• Form 44 is an application for grant of permission to
undertake for conducting Clinical Trial.
• The document design is as per the International
submission requirements of Common Technical
Document (CTD) and has five Modules.
• Module I: Administrative/Legal Information
• Module II: Summaries
• Module III: Quality Information (Chemical,
Pharmaceutical and Biological)
• Module IV: Non-Clinical Information
• Module V: Clinical Information

12. Cont…
• A clinical trial application utilizes Form 44,
accompanied by documents.
– Chemical and pharmaceutical information,
– Animal pharmacology,
– Toxicology data,
– Clinical pharmacology data.
• Other trial-related documents that must be submitted
for approval include the
– Investigator’s Brochure,
– Trial protocol, amendments
– Case report form,
– Informed consent form,
– Investigator’s undertaking.
– Trial’s regulatory status of the trial in other countries must
be reported.

13. Recent regulatory reforms initiated by
CDSCO:
Fast-tracking approval timelines:
• If the application is complete, first response
from the DCGI office can now be expected
within 30 days.

14. Cont…
• Single-window clearance for export No Objection
Certificate (NOC):
• Earlier, after obtaining permission from the DCGI for
conducting a trial, an applicant had to apply separately to
the Directorate General of Foreign Trade (DGFT) for an
export NOC. This process has now been simplified and
fast tracked, so that an applicant can apply for trial
permission as well as export NOC to DCGI, without the
need for a separate application to DGFT.
• As per revised timelines, export NOC can now be
expected within 10 working days, in contrast to the
previous 2-4 weeks timeline for DGFT approval.

15. • Mandatory registration with Clinical Trials
Registry-India (CTRI):
• The National Clinical Trial Registry (www.ctri.in)
launched by National Institute of Medical
Statistics (NIMS) under the Indian Council of
Medical Research (ICMR) has been operative for
the last two years.
• CTRI ensures accountability and transparency in
conducting trials that are the two essential
demands of globalisation.
Cont…

16. India is making a name for itself as
a preferred destination for
clinical trials

17. Thank you…..