dr. surinder singh
TRANSCRIPT
National Drug Authority Its Structure and ActivitiesSeminar 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 DrugsDrugs and Cosmetics Act, 1940Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
Drugs and Cosmetics Rules, 1945 made under the Act
Drug Price Control Order (DPCO), 1995
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 DSCODrugs Controller General (I)HEAD QUARTER ZONAL OFFICE (4) SUB ZONAL OFFICE (2) PORT OFFICE (7) LABORATORY (6)
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
STRUCTURE AT STATE LEVELSTATE DRUGS CONTROL ORGANISATION
DRUGS CONTROLLER/ COMMISSIONERDEPUTY DRUGS CONTROLLER
DRUGS TESTING LABORATOTY
GOVT. ANALYST
DRUGS INSPECTOR
ANALYST
SUPPORTING STAFF
SUPPORTING STAFF
Total No. of Drugs Inspectors Total No. of Drugs Manufacturers Total No. of Sales Premises
: : :
~1000 ~10000 ~ 500000
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Functions of CDSCOApproval of new drugs and clinical trials
Import Registration and LicensingLicensing 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 AuthoritiesLicensing 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 DrugsRequirements 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 INDIND Applicant CDSCO HQ
Examination by New Drug Division
Detailed Review by IND Committee 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 LicensingMfg sites and Products are required to be Registered Issue of Import License in Form 10 / 10A
Rules 21 to 30 Schedule DI & DII Timeline
Rules related to grant of Registration Certificate and Import License Information required for registration of Mfg site and Product Registration Certificate(RC) and Import License - Valid for 3 years
For RC: As per D& C Rules, 9 Months ,However in practice, 2 months For Import License2 -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*CLAA Approval and Grant of LicenseLicense Prepared by State Licensing Authority
Manufacturer
STATE LICENSING AUTHORITY
Joint Inspection by State and Central Inspectors
Examination of Report
*
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
CDSCO
NPAC
ZPC RPCN N N N N N N N E S E S E S E S E S S E S E S E S E S E 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 CDACentral Drug Administration Drugs Controller General
Office - 1
Office - 2
Office - 3
Regulatory Affairs and Enforcement
New Drugs & Clinical Trials Enforcement Biologicals & Biotechnology products
Organizational services
Division for Import
Training & Services
Pharmacovigilance
Quality control
Medical Devices and Diagnostics
Legal and Consumer Affairs
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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TimelinesApproval Export NOC Dual use, Rule 37 & Neutral code Additional indication etc. Form 10 Test License First response to New Drug FDC first response Endorsement of additional products on registration Registration
Time Frame2 Weeks 3 Weeks 4 Weeks 4 Weeks 4 Weeks 6 Weeks 6 Weeks 8 Weeks 12 weeks
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