PharmaceuticalsRegistrationinIndia-123566563681-phpapp01

8/8/2019 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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PharmaceuticalsRegistrationinIndia-123566563681-phpapp01