Dr. Surinder Singh[1]

8/14/2019 Dr. Surinder Singh[1]

1/24

1

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


2/24

2

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.


3/24

3

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


4/24

4

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


5/24

5

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)


6/24

6

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


7/24

7

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


8/24

8

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


9/24

9

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


10/24

10

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.


11/24

11

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


12/24

12

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


13/24


14/24

14


15/24

15


16/24

16


17/24

17


18/24

18


19/24

19


20/24

20


21/24

21


22/24

22


23/24

23


24/24

Dr. Surinder Singh[1]

Documents

Transcript of Dr. Surinder Singh[1]