BASIC CDSCO AND ICMR GUIDLINES REQUIRED IN CLINICAL TRIALS

1. Presented by:-
Karan N. Chainani
F.Y. M.Pharm(Sem-I)
Roll No. 543
Sinhgad College Of Pharmacy
Department Of Pharmacology

2. Central Drug Authority
discharging functions
assigned to the Central
Government.
CDSCO:
 Six zonal offices.
 Four sub-zonal offices.
 11 port offices.
 Six laboratories
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3.  Regulatory control over the import of drugs, approval of new
drugs and clinical trials, meetings of Drugs Consultative
Committee (DCC) and Drugs Technical Advisory Board
(DTAB).
 Zonal offices carry out joint inspections and coordinate with
the State Drugs Controllers .
 Port offices conduct Quality control of drugs imported.
 Drugs Testing Laboratories tests drug samples forwarded to
them for test.
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4.  Strengthning of CDSCO: 216 new posts(2008-2009)
 Initiatives at International Forum: Collaborations
with drug regulatory athorities like USFDA, Health Canada,
Brazil and South Africa.
 Overseas Inspections: Manufacturing sites of foreign
manufactutrers exporting to India.(2011).
 Pharma Zones at Port of Entry of Drugs:
Storage and Sampling of drugs meant for import and export.
 Banning of Drugs: Sections 26A (D & C Act, 1940)
Prohibition of drugs. (eg. PPA)
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5.  Promotion of Generic drugs: Single ingredient drug
as generic drug .(June 2011)
 Strengthning Clinical Trial Regulations:-
 G.S.R . 53(E) (Jan 2013): Analysis of Serious Adverse
Events and procedure for payment.
 G.S.R. 63(E) (Feb 2013): Conditions for conductunce of
CT.
 G.S.R. 72(E) (Feb 2013): Requirments and guidelines for
registration of Ethics Committee.
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6.  Updation of Indian Pharmacopoeia every year.
 Released National Formulary (March 2013) after 32 years.
 Analysing and Validating drug samples at air port.
 PHARMACOVIGILANCE:
 Pharmacovigilance Programme of India (July 2010).
 300 Medical colleges involved.
 Safety and Efficacy of new drugs.
 Approximately 45,000 ADR’s collected, collated and
communicated to WHO-UMC(Sweden)
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7.  CDSCO OFFICE ORDER (May 2015): Pharmaceuticals
Industries were informed to submit Adverse Drug
Reactions(ADRs) of respective products to National
Coordination Center(NCC) & Pharmacovigilance Programme
of India(PvPI) .
 Individual Case Safety Reports(ICSRs) in Vigiflow, a WHO-
UMC, Web Database. Also this will be improve the process of
assessment and signal detection.
 Effective from 1st June, 2015.
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8.  Background:-
 The Nuremberg Code (1947)
 The International Covenant on Civil and Political
Rights(1966)
 ‘Policy Statement on Ethical Considerations involved in
Research on Human Subjects’ (1980)
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9. (a) General Principles on Research
(b) Specific Principles on Research
- These Statements of General and Specific Principles may
be varied, amended, substituted and added from time to
time.
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10. Medical and related research using human beings as research
participants must necessarily ensure :-
 Purpose
 Conditions of conduction
 Evaluation
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11.  Principles of essentiality
 Principles of voluntariness, informed consent and community
agreement
 Principles of privacy and confidentiality
 Principles of precaution and risk minimisation
 Principles of professional competence
 Principles of institutional arrangements
 Principles of totality of responsibility
 Principles of compliance
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12.  Clinical Evaluation Of Drugs
 Vaccines
 Devices
 Diagnostics
 Herbal Remedies
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13.  Placebo requires careful consideration for approval. Denial of
available treatment is unethical.
 Trial without approval of Indian Regulatory Authority.
 Sponsoring drugs after success of trials .
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14.  Phase I :
1. Safety and biological effects
2. Dose and route of administration
3. Involve low risk participants
 Phase II :
- Initial trials examining effectiveness (immunogenicity) and
dose range in target groups who are at risk of exposure to
pathogens.
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15.  Phase III:
- Focuses on safety and effectiveness (in thousands) through
multicentric studies.
 Phase IV Studies (Post-Licensure Evaluation) :
- Rarer or unexpected events (not seen in Phase II/ III studies)
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16.  CDSCO official website
 Indian Council of Medical Research. Ethical
Guidlines for Biomedical Research on Human
Subjects. New Delhi : 2000
 Government of India. Good Clinical Practices for
Clinical Research in India.New Delhi : 2001
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17. THANKYOU…
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