CDSCO AND ICMR GUIDELINES

Presented by:-

Karan N. ChainaniF.Y. M.Pharm(Sem-I)

Roll No. 543

Sinhgad College Of PharmacyDepartment Of Pharmacology

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CDSCO(Central Drug Standard Control Organization)

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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FUNCTIONS OF CDSCO 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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AMENDMENTS

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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Cont… 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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INDIAN PHARMACOPEIA COMMISSION(2009)

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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Recent Amendment

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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INDIAN COUNCIL OF MEDICAL RESEARCH 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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ICMR CODE

(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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GENERAL STATEMENT

Medical and related research using human beings as research participants must necessarily ensure :-

Purpose

Conditions of conduction

Evaluation

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STATEMENT OF GENERAL PRINCIPLES

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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Clinical Evaluation Of Drugs Vaccines Devices Diagnostics Herbal Remedies

STATEMENT OF SPECIFIC PRINCIPLES FOR:

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SPECIFIC PRINCIPLES FOR DRUG TRIALS

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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VACCINE TRIALS

Phase I : 1. Safety and biological effects2. 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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Cont..

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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REFERENCES

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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THANK YOU…