pharmaceuticalsregistrationinindia-123566563681-phpapp01
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DIA Training Course
Surya Chitra, Savio Group Inc
Sunder Venkatraman, Asian Clinical Trials
DIA Training Course
Surya Chitra, Savio Group Inc
Sunder Venkatraman, Asian Clinical Trials
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Regulations in India
Statutory Functions
Statutory Functions
e
n ra overnmen sStatutory Functions
a e overnmen sStatutory Functions
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Major Regulatory Bodies
DCGI: Drugs Controller General of India
DGFT: Directorate-General of Foreign Trade
DBT:Department of BiotechnologyGEAC: Genetic Engineering Approval Committee
RDAC: Recombinant DNA Advisory Committee
IBSC: Institutional Biological Safety Committees
RCGM: Review Committee on Genetic Manipulation
DCGI: Drugs Controller General of India
DGFT: Directorate
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
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State Government Statutory FunctionsLicensing 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
Pre and Post licensing inspection
Administrative actions
Licensing of Drug testing labs
Approval of drug formulations for manufacture
Monitoring for quality of drugs and cosmetics, manufactured by
Recall of substandard drugs
Investigation and prosecution in respect to contravention of legalprovisions
Pre and Post licensing inspection
Administrative actions
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Central Government Statutory Functions
Approve licenses to manufacture certain categories of drug as CentralLicense 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
Approve licenses to manufacture certain categories of drug as Central
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
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National Government
Ministry of Environment
Ministry of Chemicals &
Petrochemicals
The Regulatory Affairs Organization Chart
Ministry of health andwelfare
Central Drug Standard&
Control Organization
Drug Controller
General of India
HQ Zonal Offices
GEAC NPPA DCP
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Beyond Guidelines
Trial can be initiated only afterpermission from Licensing Authorityand approval from ethics committee.
permission from Licensing Authorityand approval from ethics committee.
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General of India) which is the main regulatorybody.
Drug Registration and Biologics/Pharmaceuticalsin India
Drugs are registered with DCGI( Drug ControllerGeneral of India) which is the main regulatorybody.
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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)
Drugs & Cosmetics Act &
GCP Guidelines, 2001
National Pharmacovigilance Programme, 2004
Schedule Y, 2005
ICMR Guidelines, 2000 (being revised)
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New Regulations Governing Clinical Research inIndia
In keeping with
Global regulatory standards
India specific cultural, social, political and administrative
In keeping with
Global regulatory standards
India specific cultural, social, political and administrativecondition
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Sponsors Responsibilities
ProtocolReporting timelines
Adequate TrainingSponsors Study team, Investigators team
Resources /InfrastructureInsurance/Expenses for medical management of AEsMonitoring
ProtocolReporting timelines
Adequate TrainingSponsors Study team, Investigators team
Resources /InfrastructureInsurance/Expenses for medical management of AEsMonitoring
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Compilation /Evaluation of safety reports
Dissemination
Generate Investigator Notifications when required
Generate periodic safety update reviews and submit to
Sponsors Responsibilities
Compilation /Evaluation of safety reports
Dissemination
All concerned parties (Regulators/ Investigators/ Ecs)
Generate Investigator Notifications when required
Generate periodic safety update reviews and submit to DCGI
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Investigators 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
Understand Protocol requirements
Training of his team members
Provision of necessary resources &
Monitor, capture & documents ALL AEs
Medical care including follow up AE
Report to sponsor and IEC
Archives
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Responsibilities of Ethics Committees and
DSMBs
ECs
Review: safeguard rights, safety and well-being of participant
Monitor: SAE reports, annual reports, project reports
Ongoing Review
ECs
Review: safeguard rights, safety and well
Monitor: SAE reports, annual reports, project reports
DSMBs
Ongoing Review
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Schedule Y(2005 Amendment) -Statute
Guidelines:
Declaration of Helsinki
ICH
ICMR Guidelines
Guidelines:
Declaration of Helsinki
ICH-E6 GCP Guidelines
ICMR Guidelines
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Schedule Y
Ethics Committee
Composition, quorum prescribed
SOPs mandatory
Amendment approvals
Review of agreements Approval format prescribed(http://www.cdsco.nic.in)
Composition, quorum prescribed
SOPs mandatory
Amendment approvals
Review of agreements Approval format prescribed(http://www.cdsco.nic.in)
http://www.cdsco.nic.in%29/http://www.cdsco.nic.in%29/http://www.cdsco.nic.in%29/http://www.cdsco.nic.in%29/ -
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Freely given, informed, written consent in
Constitution, quorum and approval
Ethical Issues
Freely given, informed, written consent in
Constitution, quorum and approval format
as per Appendix VIII
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Investigators may accept Approval granted
by EC of another siteor approval granted byan independent ethics committee
Provisions for Using Independent EC
by EC of another siteor approval granted byan independent ethics committee
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Roles and Responsibilities
PSUR mandatory
Protocol Format (Appendix X)
Report format (Appendix II)
Reporting Timelines specified: Unexpected SAEs within14
Stability testing
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
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Training/Qualifications
Investigators to document SOPs for all tasksperformed by
themResponsible for conduct of trial according to protocol
Compliance as per undertaking
Medical care for AEs
SAE reporting to EC (7days) and Sponsor (24hrs)
Informed consent
Investigators
Training/Qualifications
Investigators to document SOPs for all tasks
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
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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
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
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National Pharmacovigilance Advisory Committee
Advisory Committee to Government
16 members
Supervise activities of National Pvig
Advisory Committee to Government
16 members
Supervise activities of National PvigProgram
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Protocol Amendments
Amendments which do not require notification or permission of the LicensingAuthority
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
Amended IB or ICF
Additional Patients to be recruited
Major changes in protocol with respect to study design, dose and treatment .Any change in inclusion/exclusion criteria
Amendments which do not require notification or permission of the Licensing
Administrative and logistic changes,
Minor protocol amendment and additional safety assessments
Amendments which require notification to Licensing Authority, but sponsor need
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
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Global Clinical Trials are classified into 2 categories:
Category A:
It includes clinical trials whose
protocols have been approved by
USA, UK, Switzerland,
South Africa, Japan or the EMEA.
The regulatory (DCGI) will reach to a
decision whether to approve the
trial within 2-4 weeks.
It includes clinical trials whose protocols
have been approved in other countries
which are not listed in category A.
The regulatory (DCGI) turnaround time
for these applications
will be 8-12 weeks.
Category B::
It includes clinical trials whose
protocols have been approved by
USA, UK, Switzerland,
Australia, Canada,Germany,
South Africa, Japan or the EMEA.
The regulatory (DCGI) will reach to a
decision whether to approve the
trial within 2-4 weeks.
have been approved in other countries
which are not listed in category A.
The regulatory (DCGI) turnaround time
for these applications
will be 8-12 weeks.
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Implementation of Schedule YGCP: Shared responsibility amongst
Need for imparting training to all the
Future directions
Implementation of Schedule YGCP: Shared responsibility amongst
different stakeholders in clinical trials
Need for imparting training to all theplayers
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Drugs and Cosmetics Act 1945
Rule Permission for
122 A
B
Import
Manufacture [except drugsunder schedule C and C(1)]
B
122 D
122 DA
122 DAA
122 E
Manufacture [except drugsunder schedule C and C(1)]
Fixed dose combination
Clinical trial
CT definition
New drug definition
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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
A New drug is considered new for the period of 4 years
Not used in the country
Approved drug : 1. New claims
All Vaccines are considered New drugs unless certifiedby 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 theIndian Pharmacopoeia, whichever is earlier
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Intent to conduct Phase I*,II or III Pharmaceutical product or Medical
Device Clinical Trial in India
Determine ifSubmission to be made
under CategoryA or B
Parallel submission to
Ethics Committee
Category A Category BIn Case Central lab outside
India used
Note: fill aayat niryath form according to category A or B
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In case of category A
Category AClinical 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
Application compiled
per checklist on
CDSCO website APPROVED
NOC received fromDCG(I)
if trial approved(Internal process)
Application made to DCGI
for approval in form 44& import license inform 12; fees paid
Application evaluated forCompleteness if found appropriate
approval normally granted in4-6 weeks
REJECTED
DCG(I)
if trial approved(Internal process)
DGFT (Delhi)Approval receivedwithin 4-6 weeks
Apply to Jt.DGFTof the respective city/state
with cover letter &
NOC from DGFT Delhi
Exportlicense
receivedWithin
2 weeks
ResubmitApplication
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Medical Device guidelines amended in Mar. 1, 2006
The newly included drugs are Cardiac stents, drug
Medical Device guidelines
Medical Device guidelines amended in Mar. 1, 2006
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.
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New guidelines have been introduced on Recombitant
Pharma.
There Approval bodies is DCGI but there are asissting
Recombitant Pharma guidelines
New guidelines have been introduced on Recombitant
There Approval bodies is DCGI but there are asissting
bodies like GEAC, RCGM, IBSC.
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