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National Drug Authority – Its

Structure and Activities

Seminar on Clinical Trials: The Heart of Medical Science


on 4th November, 2008 at Assocham House, New Delhi

By
Dr. Surinder Singh
Drugs Controller General (India)
CDSCO, Directorate General of Health Services, Ministry
of Health & Family Welfare, Govt. of India, New Delhi
www.cdsco.nic.in

CD SCO

Drug Regulatory System

• Health is in concurrent list of Indian


constitution
• It is governed by both Centre and State
Governments

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Legal Enactments to Regulate
Import, Manufacture & Sale of Drugs
Drugs and Magic
Drugs and Remedies
Cosmetics Act, (Objectionable
Advertisements)
1940
Act, 1954

Drugs and Drug Price


Cosmetics Rules, Control Order
1945 made under (DPCO), 1995
the Act

The overall objective of a Drug Regulatory


Authority (DRA) is to ensure that medicinal
products are of acceptable quality, safety and
efficacy, are manufactured and distributed in
ways which ensure their quality until they
reach the patient/consumer, and their
commercial promotion is accurate.

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C DSCO
Drugs Controller General (I)

ZONAL SUB ZONAL PORT OFFICE LABORATORY


HEAD QUARTER
OFFICE (4) OFFICE (2) (7) (6)

•Import
•GMP Audits •GMP Audits •Export •Testing of drug
•Coordinations •Coordinations Samples
•New Drugs with States with States •Validation of
•CLAA Test protocol
•Imports
•DTAB/ DCC

STRUCTURE AT STATE LEVEL


STATE DRUGS CONTROL ORGANISATION

DRUGS CONTROLLER/ COMMISSIONER DRUGS TESTING LABORATOTY

DEPUTY DRUGS CONTROLLER GOVT. ANALYST

DRUGS INSPECTOR ANALYST

SUPPORTING STAFF SUPPORTING STAFF

Total No. of Drugs Inspectors : ~1000


Total No. of Drugs Manufacturers : ~10000
Total No. of Sales Premises : ~ 500000

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Functions of CDSCO

Approval of new drugs and clinical trials

Import Registration and Licensing

Licensing of Blood Banks, LVPs, Vaccines, r-DNA


products & some Medical Devices

Amendment to D &C Act and Rules

Banning of drugs and cosmetics

Grant of Test License, Personal License, NOCs for Export

Testing of Drugs

Functions of State Licensing Authorities

Licensing of Manufacturing Site for Drugs including API and


Finished Formulation

Licensing of Establishment for sale or distribution of Drugs

Approval of Drug Testing Laboratories

Monitoring of Quality of Drugs and Cosmetics marketed in the


country

Investigation and prosecution in respect of contravention of


legal provision

Recall of sub-standard drugs

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Approval of Clinical Trials, Import, &
Manufacture of New Drugs

Requirements and Guidelines - Schedule Y

Rule 122 A Permission to import new drug

Rule 122 B Permission to manufacture new drug

Rule 122 DA Definition of Clinical trials

Rule 122 E Definition of New Drugs*

• New substance having therapeutic


indication
• Modified or new claims, new route of
administration for already approved drug
• Fixed Dose Combination

Approval of IND
IND Applicant CDSCO HQ

Examination by New
Drug Division

Detailed Review by IND


Committee Approval

Timeline –
Phase I – 90 days
Phase II – 45 days Recommendation
to DCG(I)
Phase III – 60 days

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Import, Registration and Licensing
Mfg sites and Products are required to be Registered

Issue of Import License in Form 10 / 10A

Rules Rules related to grant of Registration


21 to 30 Certificate and Import License

Schedule Information required for registration of Mfg


site and Product
DI & DII

Timeline Registration Certificate(RC) and


For RC: As per D& C Import License - Valid for 3 years
Rules, 9 Months ,However
in practice, 2 months
For Import License As per Rule 24A (5), there is provision to inspect overseas
manufacturing site for which manufacturer has to pay 5000 USD
2 -3 weeks

Requirements For Import and


Registration
• Registration of overseas Manufacturing
site and Drugs

• Registration Certificate issued in form 41


by the Licensing Authority

• Import License issued in Form 10 or 10A

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Central Licensing*
CLAA
Approval and
Grant of License

License Prepared by
State Licensing
Manufacturer Authority

STATE LICENSING Joint Inspection


by State and Examination of
AUTHORITY
Central Report
Inspectors

* For Biologicals, Large volume parenterals (LVP), Blood bank and


blood products & Some Medical Devices

Global Clinical Trials

• Permission is required from CDSCO for


conducting global clinical trials in the
country
• Phase I for New Drug substance
developed outside India is not permitted
• So far, approx. 500 permissions have been
granted since 2003

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National Pharmacovigilance
Programme

NPAC
CDSCO

ZPC

RPC

NN N
N N
N N N E
S E
S E
S E
S S
E E
S S
E S
E S
E E
S W W W W W
PPC

NPAC = National Pharmacovigilance Advisory Committee, ZRP = Zonal


Pharmacovigilance Centre, RPC = Regional Pharmacovigilance Centre, PPC
= Peripheral Pharmacovigilance Centre

Proposal to Create CDA


• Setting up of autonomous Central Drugs
Authority (CDA) of global standards under
the Ministry of Health & FW.
• To introduce a system of centralized
licensing for manufacture of drugs
• Bill has already been introduced in the
Parliament

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Proposed Structure of CDA
Central
Drug
Administration

Drugs Controller General

Office - 1 Office - 2 Office - 3

Regulatory Affairs and New Drugs & Clinical Trials


Organizational services
Enforcement Enforcement

Biologicals &
Division for Import Training & Services
Biotechnology products

Pharmacovigilance Quality control

Medical Devices and


Legal and Consumer Affairs
Diagnostics

Collaborations
• With Health Canada, US FDA, Brazil,
South Africa to strengthen

– Functioning in several areas including


monitoring drugs for adverse reactions,
regulating medical devices, clinical
practices and biological drugs

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Clinical Trial Inspection
• Inspection of clinical trial sites is an
important tool to ensure subject protection
and integrity of data.
• To develop knowledge and skill in
inspecting clinical trial sites, implementing
GCP inspection programme, CDSCO has
collaborated with US FDA.

Clinical Trial Inspection


• The first USFDA-CDSCO collaborative
GCP inspection workshops conducted in
September 2008.
• Next advanced workshop planned in May
2009.
• Each workshops will be followed by series
of regional workshops across the country.

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Expansion of Organization
• Shifted to the state of the art FDA Bhawan
• Aggressive approach in filling up vacant
posts and creating new vacancies
• Contractual staff hired for smooth
functioning of the organization

Image Upliftment of CDSCO


• Corporate culture
• Professional approach
• Moral boost
• Modulating work culture
• Strict timelines
• Interactive workshops
• Sending staff abroad

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Timelines
Approval Time Frame

• Export NOC 2 Weeks


• Dual use, Rule 37 & Neutral code 3 Weeks
• Additional indication etc. 4 Weeks
• Form 10 4 Weeks
• Test License 4 Weeks
• First response to New Drug 6 Weeks
• FDC first response 6 Weeks
• Endorsement of additional 8 Weeks
products on registration
• Registration 12 weeks

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