pharmaceuticals registration in india
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Pharmaceutical Registration In India
DIA – Training CourseSurya Chitra, Savio Group Inc
Sunder Venkatraman, Asian Clinical Trials
Pharmaceutical Registration In India
DIA – Training CourseSurya Chitra, Savio Group Inc
Sunder Venkatraman, Asian Clinical Trials
Regulations in India
Central GovernmentsStatutory Functions
State GovernmentsStatutory Functions
Central GovernmentsStatutory Functions
State GovernmentsStatutory Functions
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
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
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
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
Central Government Statutory Functions
Approve licenses to manufacture certain categories of drug as Central License Approving
Regulate CR in IndiaEstablish regulatory measures, amendments to acts and rulesScreening drug Formulations available in Indian MarketRegulate MA of new drugRegulate the standards of imported drugsConduct training programs for regulatory officials and catalyst In IndiaPublication of Indian Pharmacopoeia
Approve licenses to manufacture certain categories of drug as Central License Approving
Regulate CR in IndiaEstablish regulatory measures, amendments to acts and rulesScreening drug Formulations available in Indian MarketRegulate MA of new drugRegulate the standards of imported drugsConduct training programs for regulatory officials and catalyst In IndiaPublication of Indian Pharmacopoeia
National Government
Ministry of EnvironmentMinistry of Chemicals &
Petrochemicals
The Regulatory Affairs Organization Chart
Ministry of health andwelfare
Central Drug Standard&Control Organization
Drug ControllerGeneral of India
HQ Zonal Offices
GEAC NPPA DCP
Beyond Guidelines
Trial can be initiated only afterpermission from Licensing Authorityand approval from ethics committee.
Trial can be initiated only afterpermission from Licensing Authorityand approval from ethics committee.
Drugs are registered with DCGI( Drug Controller General of India) which is the main regulatory body.
Drug Registration and Biologics/Pharmaceuticalsin India
Drugs are registered with DCGI( Drug Controller General of India) which is the main regulatory body.
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 & Rules (Schedule Y1988)
GCP Guidelines, 2001
National Pharmacovigilance Programme, 2004
Schedule Y, 2005
ICMR Guidelines, 2000 (being revised)
New Regulations Governing Clinical Research in India
In keeping with
Global regulatory standards
India specific cultural, social, political and administrative condition
In keeping with
Global regulatory standards
India specific cultural, social, political and administrative condition
Sponsor’s Responsibilities
ProtocolReporting timelinesAdequate TrainingSponsor’s Study team, Investigators teamResources /InfrastructureInsurance/Expenses for medical management of AEsMonitoring
ProtocolReporting timelinesAdequate TrainingSponsor’s Study team, Investigators teamResources /InfrastructureInsurance/Expenses for medical management of AEsMonitoring
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
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
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
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
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
ECs
Review: safeguard rights, safety and well-being of participant
Monitor: SAE reports, annual reports, project reports
DSMBs
Ongoing Review
Schedule Y(2005 Amendment) -Statute
Guidelines:
Declaration of Helsinki
ICH-E6 GCP Guidelines
ICMR Guidelines
Guidelines:
Declaration of Helsinki
ICH-E6 GCP Guidelines
ICMR Guidelines
Schedule Y
Ethics Committee
–Composition, quorum prescribed
–SOPs mandatory
–Amendment approvals
– Review of agreements
– Approval format prescribed(http:// www.cdsco.nic.in)
Ethics Committee
–Composition, quorum prescribed
–SOPs mandatory
–Amendment approvals
– Review of agreements
– Approval format prescribed(http:// www.cdsco.nic.in)
Freely given, informed, written consent in prescribed form Appendix V
Constitution, quorum and approval format as per Appendix VIII
Ethical Issues
Freely given, informed, written consent in prescribed form Appendix V
Constitution, quorum and approval format as per Appendix VIII
Investigators may accept Approval granted by EC of another siteor approval granted by an independent ethics committee
Provisions for Using Independent EC
Investigators may accept Approval granted by EC of another siteor approval granted by an independent ethics committee
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
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
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
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
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
Pharmacovigilance in India
1998:
•India established national centre at AIIMS
•Joined Uppsala programme
•WHO Special Centre at KEM Hospital
2004:
•National PharmacovigilanceProgramme launched on 23rd November 2004
1998:
•India established national centre at AIIMS
•Joined Uppsala programme
•WHO Special Centre at KEM Hospital
2004:
•National PharmacovigilanceProgramme launched on 23rd November 2004
National Pharmacovigilance Advisory Committee
Advisory Committee to Government
16 members
Supervise activities of National PvigProgram
Advisory Committee to Government
16 members
Supervise activities of National PvigProgram
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 recruitedMajor 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 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 recruitedMajor changes in protocol with respect to study design, dose and treatment .Any change in inclusion/exclusion criteria
Global Clinical Trials are classified into 2 categories:
Category A:
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.
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:Category A:
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.
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.
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
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
Implementation of Schedule Y
GCP: Shared responsibility amongstdifferent stakeholders in clinical trials
Need for imparting training to all theplayers
Future directions
Implementation of Schedule Y
GCP: Shared responsibility amongstdifferent stakeholders in clinical trials
Need for imparting training to all theplayers
Drugs and Cosmetics Act 1945
Rule Permission for
122 A
122 B
Import
Manufacture [except drugsunder schedule C and C(1)]
122 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
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
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
Intent to conduct Phase I*,II or III Pharmaceutical product or Medical
Device Clinical Trial in India
Determine ifSubmission to be made
under Category A or B
Parallel submission to Ethics Committee
Category A Category BIn Case Central lab outsideIndia used
Note: fill aayat niryath form according to category A or B
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 compiledper checklist on
CDSCO website APPROVED
NOC received from DCG(I)
if trial approved (Internal process)
Application made to DCGIfor approval in form 44& import license in form 12; fees paid
Application evaluated for Completeness if found appropriateapproval normally granted in4-6 weeks
REJECTED
NOC received from 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
Export license
received Within
2 weeks
Resubmit Application
In case of category B
Determine ifSubmission to be made
under Category A or B
Category B
If study approvals as required for Category A
are not available
NOC received from DCG(I)if trial approved
(Internal process)
DGFT (Delhi) approval received within
4-6 weeks
If study approvals as required for Category A
are not available
Application compiledper attached appendix
Application made to DCGI for approval in form 44 & Import license in form 12;
fees paid as required.
Application evaluatedIf found appropriate approval normally
granted in 8-12 weeks
DGFT (Delhi) approval received within
4-6 weeks
Apply to Jt.DGFTof the respective city/state
with cover letter &NOC from DGFT Delhi
Export license received within 2 weeks
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.
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.
New guidelines have been introduced on Recombitant Pharma.
There Approval bodies is DCGI but there are asisstingbodies like GEAC, RCGM, IBSC.
Recombitant Pharma guidelines
New guidelines have been introduced on Recombitant Pharma.
There Approval bodies is DCGI but there are asisstingbodies like GEAC, RCGM, IBSC.
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