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National Drug Authority ItsStructure and Activities
Seminar on Clinical Trials: The Heart of Medical Science
on 4th November, 2008 at Assocham House, New Delhi
CDSCO
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
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
Cosmetics Act,
1940
Drugs and
Cosmetics Rules,
1945 made under
the Act
Drug Price
Control Order
(DPCO), 1995
Drugs and Magic
Remedies
(Objectionable
Advertisements)
Act, 1954
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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Drugs Controller General (I)
HEAD QUARTERSUB ZONAL
OFFICE (2)
ZONAL
OFFICE (4)
LABORATORY
(6)
PORT OFFICE
(7)
New Drugs
CLAA
Imports
DTAB/ DCC
GMP Audits
Coordinations
with States
GMP Audits
Coordinations
with States
Import
Export Testing of drug
Samples
Validation of
Test protocol
CDSCO
DRUGS CONTROLLER/ COMMISSIONER
DEPUTY DRUGS CONTROLLER
DRUGS TESTING LABORATOTY
DRUGS INSPECTOR
SUPPORTING STAFF
STRUCTURE AT STATE LEVEL
STATE DRUGS CONTROL ORGANISATIONSTATE DRUGS CONTROL ORGANISATION
GOVT. ANALYST
ANALYST
SUPPORTING STAFF
Total No. of Drugs Inspectors : ~1000Total 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
Rule 122 B
Rule 122 DA
Rule 122 E
Permission to import new drug
Permission to manufacture new drug
Definition of Clinical trials
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
Detailed Review by IND
Committee
CDSCO HQ
Examination by New
Drug Division
IND Applicant
Timeline
Phase I 90 days
Phase II 45 days
Phase III 60 days
Approval
Recommendation
to DCG(I)
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Import, Registration and Licensing
Rules
21 to 30
Schedule
DI & DII
Rules related to grant of Registration
Certificate and Import License
Information required for registration of Mfg
site and Product
Mfg sites and Products are required to be Registered
Issue of Import License in Form 10 / 10A
Registration Certificate(RC) and
Import License - Valid for 3 years
Timeline
For RC: As per D& CRules, 9 Months ,However
in practice, 2 months
For Import License
2 -3 weeks
As per Rule 24A (5), there is provision to inspect overseas
manufacturing site for which manufacturer has to pay 5000 USD
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*
* For Biologicals, Large volume parenterals (LVP), Blood bank andblood products & Some Medical Devices
STATE LICENSING
AUTHORITY
CLAA
Approval and
Grant of License
Joint Inspection
by State andCentral
Inspectors
Manufacturer
License Prepared by
State LicensingAuthority
Examination of
Report
Global Clinical Trials
Permission is required from CDSCO for
conducting global clinical trials in thecountry
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
N N N N N S S S S SS E E E E E W W W W W
CD S OC
S S S S S W W W WEEEEENNNNN
NPAC
ZPC
RPC
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 CDACentral
Drug
Administration
Drugs Controller General
Office - 1 Office - 2 Office - 3
Regulatory Affairs and
Enforcement
Division for Import
New Drugs & Clinical Trials
Enforcement
Biologicals &Biotechnology products
Pharmacovigilance
Medical Devices and
Diagnostics
Organizational services
Training & Services
Quality control
Legal and Consumer Affairs
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
Collaborations
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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 May2009.
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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TimelinesApproval 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 Weeksproducts on registration
Registration 12 weeks
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