This document summarizes regulations and guidelines for conducting pharmaceutical clinical trials in India. It outlines the major regulatory bodies like DCGI, DGFT, and GEAC. It describes the statutory functions of central and state governments regarding drug licensing, approvals, and quality monitoring. Responsibilities of sponsors, investigators, and ethics committees are provided. Key aspects like clinical trial categories, amendments, safety reporting, and biologics/device regulations are summarized.

1. Pharmaceutical Registration In India
DIA – Training Course
Surya Chitra, Savio Group Inc
Sunder Venkatraman, Asian Clinical Trials

2. Regulations in India
Central Governments State Governments
Statutory Functions Statutory Functions

3. Major Regulatory Bodies
DCGI: Drugs Controller General of India
DGFT: Directorate-General of Foreign Trade
DBT:Department of Biotechnology
GEAC: Genetic Engineering Approval Committee
RDAC: Recombinant DNA Advisory Committee
IBSC: Institutional Biological Safety Committees
RCGM: Review Committee on Genetic Manipulation

4. State Government Statutory Functions
Licensing of Drug testing labs
Approval of drug formulations for manufacture
Monitoring for quality of drugs and cosmetics, manufactured by
respective states units and those marketed in India
Recall of substandard drugs
Investigation and prosecution in respect to contravention of legal
provisions
Pre and Post licensing inspection
Administrative actions

5. Central Government Statutory Functions
Approve licenses to manufacture certain categories of drug as Central
License Approving
Regulate CR in India
Establish regulatory measures, amendments to acts and rules
Screening drug Formulations available in Indian Market
Regulate MA of new drug
Regulate the standards of imported drugs
Conduct training programs for regulatory officials and catalyst In India
Publication of Indian Pharmacopoeia

6. The Regulatory Affairs Organization Chart
National Government
Ministry of health and Ministry of Chemicals &
welfare Ministry of Environment Petrochemicals
GEAC DCP
NPPA
Central Drug Standard&
Control Organization
Drug Controller
General of India
HQ Zonal Offices

7. Beyond Guidelines
Trial can be initiated only after
permission from Licensing Authority
and approval from ethics committee.

8. Drug Registration and Biologics/Pharmaceuticals
in India
Drugs are registered with DCGI( Drug Controller
General of India) which is the main regulatory
body.

9. Clinical Research Guidelines/Regulations in India
Drugs & Cosmetics Act & Rules (Schedule Y1988)
GCP Guidelines, 2001
National Pharmacovigilance Programme, 2004
Schedule Y, 2005
ICMR Guidelines, 2000 (being revised)

10. New Regulations Governing Clinical Research in
India
In keeping with
Global regulatory standards
India specific cultural, social, political and administrative
condition

11. Sponsor’s Responsibilities
Protocol
Reporting timelines
Adequate Training
Sponsor’s Study team, Investigators team
Resources /Infrastructure
Insurance/Expenses for medical management of AEs
Monitoring

12. Sponsor’s Responsibilities
Compilation /Evaluation of safety reports
Dissemination
•Information (AEs /Safety Updates/ PSURs)
•All concerned parties (Regulators/ Investigators/ Ecs)
Generate “Investigator Notifications” when required
Generate periodic safety update reviews and submit to DCGI

13. Investigator’s responsibilities
Understand Protocol requirements
Training of his team members
Provision of necessary resources & infrastructure
Monitor, capture & documents ALL AEs
Medical care including follow up AE
Report to sponsor and IEC
Archives

14. Responsibilities of Ethics Committees and
DSMBs
ECs
Review: safeguard rights, safety and well-being of participant
Monitor: SAE reports, annual reports, project reports
DSMBs
Ongoing Review

15. Schedule Y(2005 Amendment) -Statute
Guidelines:
Declaration of Helsinki
ICH-E6 GCP Guidelines
ICMR Guidelines

16. Schedule Y
Ethics Committee
– Composition, quorum prescribed
– SOPs mandatory
– Amendment approvals
– Review of agreements
– Approval format prescribed
(http:// www.cdsco.nic.in)

17. Ethical Issues
Freely given, informed, written consent in
prescribed form Appendix V
Constitution, quorum and approval format
as per Appendix VIII

18. Provisions for Using Independent EC
Investigators may accept Approval granted
by EC of another site or approval granted by
an independent ethics committee

19. Sponsors
Roles and Responsibilities
PSUR mandatory
Protocol Format (Appendix X)
Report format (Appendix II)
Reporting Timelines specified: Unexpected SAEs within14
days to DCGI and other investigators
Stability testing

20. Investigators
Training/Qualifications
Investigators to document SOPs for all tasks performed by
them
Responsible for conduct of trial according to protocol and GCP
Compliance as per undertaking
Medical care for AEs
SAE reporting to EC (7days) and Sponsor (24hrs)
Informed consent

21. PSURs
6 monthly for 2 years; annually for 2 years
Within 30 calendar days
Different dosage forms/formulations/ indications in one report
New studies planned for safety to be described

22. Pharmacovigilance in India
1998:
•India established national centre at AIIMS
•Joined Uppsala programme
•WHO Special Centre at KEM Hospital
2004:
•National Pharmacovigilance Programme launched
on 23rd November 2004

23. National Pharmacovigilance Advisory Committee
Advisory Committee to Government
16 members
Supervise activities of National Pvig Program

24. Protocol Amendments
Amendments which do not require notification or permission of the Licensing
Authority
Administrative and logistic changes,
Minor protocol amendment and additional safety assessments
Amendments which require notification to Licensing Authority, but sponsor need
not wait for permission.
Additional investigator sites,
Change in investigator, with the consent to withdraw from the earlier
investigator.,
Amended IB or ICF
• Amendments which require prior permission of the Licensing Authority
Additional Patients to be recruited
Major changes in protocol with respect to study design, dose and treatment .
Any change in inclusion/exclusion criteria

25. Global Clinical Trials are classified into 2 categories:
Category A: Category B:
It includes clinical trials whose
It includes clinical trials whose protocols
protocols have been approved by
have been approved in other countries
USA, UK, Switzerland,
which are not listed in category A.
Australia, Canada,Germany,
The regulatory (DCGI) turnaround time
South Africa, Japan or the EMEA.
for these applications
The regulatory (DCGI) will reach to a
will be 8-12 weeks.
decision whether to approve the
trial within 2-4 weeks.

26. Advances in Schedule Y
Removal of Phase Lag
Statutory support of GCP & GLP Conversion of EC,
Sponsor, Investigator responsibilities to legal
requirements
Uniform processes for submission and approval of EC
documents and Informed Consent
Reinforcement of pharmacovigilance through Phase IV
studies, SAE reporting, PSUR etc

27. Future directions
Implementation of Schedule Y
GCP: Shared responsibility amongst
different stakeholders in clinical trials
Need for imparting training to all the
players

28. Drugs and Cosmetics Act 1945
Rule Permission for
Import
122 A
Manufacture [except drugs
122 B
under schedule C and C(1)]
Fixed dose combination
122 D
Clinical trial
122 DA
CT definition
122 DAA
122 E New drug definition

29. 122 E: New drug definition
Not used in the country
Approved drug : 1. New claims
(Indications, dosage, dosage form, route)
2. FDCs (New / Modified
All Vaccines are considered New drugs unless certified
by Licensing Authority under Rule 21
A New drug is considered new for the period of 4 years
from the date f its first approval or the date it is included in the
Indian Pharmacopoeia, whichever is earlier

30. Intent to conduct Phase I*,II or III Pharmaceutical product or Medical
Device Clinical Trial in India
Parallel submission to
Determine if
Ethics Committee
Submission to be made
under Category
A or B
In Case Central lab outside Category B
Category A
India used
Note: fill aayat niryath form according to category A or B

31. In case of category A
Category A
Clinical trial already approved by other regulatory agencies (US-FDA,
MRHA etc. as defined in the MoM-DCG(I) Oct-06) and approval letters
are available
NOC received from
Application compiled
DCG(I)
per checklist on
APPROVED if trial approved
CDSCO website
(Internal process)
Export
license
Application made to DCGI
received
for approval in form 44 Resubmit Apply to Jt.DGFT
Within
& import license in Application of the respective city/state
2 weeks
form 12; fees paid with cover letter &
NOC from DGFT Delhi
Application evaluated for
REJECTED DGFT (Delhi)
Completeness if found appropriate
Approval received
approval normally granted in
within 4-6 weeks
4-6 weeks

32. In case of category B
Determine if
Submission to be made
under Category
A or B
NOC received from DCG(I)
if trial approved
Category B
(Internal process)
If study approvals DGFT (Delhi)
as required for Category A approval received within
are not available 4-6 weeks
Application compiled Apply to Jt.DGFT
per attached appendix of the respective city/state
with cover letter &
NOC from DGFT Delhi
Application evaluated
If found appropriate
Application made to DCGI
approval normally
for approval in form 44 &
granted in 8-12 weeks
Import license in form 12; Export license received
fees paid as required. within 2 weeks

33. Medical Device guidelines
Medical Device guidelines amended in Mar. 1, 2006
bringing discipline to medical devices sector
The newly included “drugs” are Cardiac stents, drug
eluting stents, catheters, intraocular lenses, IV Cannulae,
Bone cements, heart valves, scalp vein set, orthopedic
implants and internal prosthetic replacements.

34. Recombitant Pharma guidelines
New guidelines have been introduced on Recombitant
Pharma.
There Approval bodies is DCGI but there are asissting
bodies like GEAC, RCGM, IBSC.