DRUG REGULATORY

Presentation By
y FRAMEWORK
Debasish Panda
&
Joint Secretary NEW INITIATIVES
Ministry of Health &
Family Welfare
Government of India

INDIA

Snapshot - Indian Pharma Industry

Indian Pharmaceutical Market ~US $ 18bn

Import (2008-09 )US$ 2.7 Bn
Export (2008-09
(2008 09 ) US$ 7Bn
8% global Production & 2% of World phama Market
Bulk Drug Production > 400 API’s
Export of Biotech products ~US $763M
Biopharmaceuticals ~ US $ 600 M
Manufacturing Facilities 119 US FDA Approved
g
Largest Number of Manufacturing g Facilities outside US
153 EDQM approved facilities (49 sites with CEP Approvals)
Abbreviated New Drug approval Filing - 2nd to USA
DMF submissions in US (1998-2007) ~ 10% (32 out of 316)

1
Final ANDA Approvals Granted in US (2008) - Countrywise

Country Numbers
¾USA 169
¾India 132
¾Israel 40
¾Germany 25
¾Canada 24
¾Switzerland 19
¾Iceland 14
¾Jordan 11
¾Other 25
Source: Thomson Scientific

Indian Vaccine & Biopharma Industry

¾Vaccine & Biopharma

¾400 organized pharma sector
¾200 companies in biotech Sector
¾Growth rate is 37% in 2006-07
¾Total production of biopharmaceuticals is >US
$ 1Bn

2
 Indian Pharmaceutical Industry: EXPORTS

8
1980-81 7.30
1990-91
7
2000-01 6.011
2001-02 5.818
6
2002-03
2003-04
5
USD Billion

2004-05
2006-07 4.121
4
2007-08
3.42
2008-09 2.850 2.81
3

2.05
2

1
0.184
0.009
0
1980-81 1990-91 2000-01 2001-02 2002-03 2003-04 2004-05 2006-07 2007-08 2008-09

Trade with Africa Countries

USD Bn % Growth
y Total Pharma Export 5.66 12.78
y African
Af i C
Countries
ti 0 87
0.87 17 81
17.81

Share of Exports to
African Countries 13.53%

3
TOP 5 countries Sorted by Share of Market Region Wise

Southern Africa North Africa

South Africa 62.08% Sudan 34.23%
Zambia 12.02% Egypt 30.41%
Angola 10.12% Algeria 23.69%
Mozambique 4.80% Morocco 6.58%
Namibia 3.72% Libya 3.33%

East Africa West Africa

Kenya 36.71% Nigeria 53.37%
Tanzania 19.54% Ghana 16.36%
Uganda 18.58% Guinea 8.50%
Ethopia 14.26% Benin 4.01%
Mauritius 6.18% Senegal 3.01%

Central Africa
Chad 4.18% Gabon 3.75%
Cameroon 33.31% Congo Rep 0.68%
Equtl Guinea 0.28

Vaccines – Exported to 151 Countries

4
 WHO‐PREQUALIFIED INDIAN VACCINE MANUFACTURERS
(As of June, 2009)
• Bharat Biotech International Limited       ‐ Hepatitis B (recombinant) (Revac‐B+)

• Haffkine Bio Pharmaceutical Corp. Ltd.   ‐ OPV (from bulk supplied by Biofarma, Indonesia)

• Novatris Vaccines and Diagnostics S.r.l   ‐ Rabies 
India, (Formerly Chiron Behring)

• Panacea Biotech ‐ DTwP  Biofarma ‐ Hib Novatris (1dose) (EASYFOUR) 

DTwP  Biofarma ‐ Hepatitis B  P.H.B. ( 1dose) (ECOVAC)
DTwP  Biofarma‐Hep B P.H.B. ‐ Hib P.H.B. (1dose) (EASYFIVE)
Hepatitis B ( Enivac B)
OPV ( from bulk supplied by Biofarma, Indonesia)
OPV (from bulk supplied from Chiron, Italy)

• Serum Institute of India Ltd. ‐ BCG, DT, dT, DTwP , DTwP‐Hep B, 
Hep B(recombinant) , Hib, TT, MR, 
MMR , Measles, Rubella 

• Shantha Biotechnics Private Ltd.  ‐ Hepatitis B (recombinant), DTwP‐Hep B (Shantetra),  TT (Shan TT),  
DTwP‐Hepatitis B‐Hib ( Shan5) (1dose and 10 doses) 

• Zydus Cadila ‐ Rabies

India – Well defined Drug Regulatory System

Govt. of India
Ministry of Ministry of Ministry of Ministry of
Health & Family Chemicals & Commerce science &
welfare fertlizers Technology
Patent Office
DGHS Department of ICMR
Pharmaceuticals Controller General
CDSCO of patents DBT
NPPA
DCGI DTAB CSIR Labs
¾Enforcement &
GMP audit Div
¾Quality Control
Division CDTL
Division-CDTL
¾Registration Div
¾New Drugs Div.
¾Pharmacovigilance
¾Trainings

5
 Drugs regulatory system in India
Drugs is in concurrent list
of Indian Constitution
It is governed by both
Centre and State
Governments

Legal Enactments to Regulate Import, Manufacture & Sale of Drugs

Drugs and
Cosmetics
A t 1940
Act,

Drugs and Magic

Remedies
(Objectionable
Advertisements)
Act, 1954

Drugs and
Cosmetics
Rules, 1945
made under
the Act

6
CDSCO – Geographical Location of 6 Zonal Offices
CDSCO, HQ

CDSCO North Zone (Ghaziabad)

CDSCO West Zone (Mumbai)

New Delhi
CDSCO South Zone (Chennai)
Ahmedabad * .
CDSCO East Zone (Kolkata)
Kolkata
New Zonal Offices – Mumbai
Ahmedabad & Hyderabad
Sub Zonal Office
Sub- :2 •** Hyderabad
H d b d
Port Offices/Airports : 7
Laboratories :6
Chennai
29 States
6 Union Territories

Functions of CDSCO
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

7
 Functions of State Licensing Authorities

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

CDSCO -Number of Applications received/processed

From Year 2005-09

25000

20000
No. of Applications

16945

15000 12945 13370

10160 11061 Series 1

10000 Series 2
Expected
applications by
Year 2009 end
5000
N

0 Jan-June
2005 2006 2007 2008 2009
Year(Jan-Dec)

8
 Status of various categories of applications received/processed
From Jan 2005 to 30th June 2009 

S.No Subject Year Year 2006* Year 2007* Year 2008* Year 2009
2005* (Jan-Dec) (Jan-Dec) (Jan-Dec) (Jan-June)
(Jan-Dec)
1 New Drug Applications 1200 1500 1600 1750 920
2 Global Clinical Trials 100 170 300 350 130
3 Vaccines and Biotech 10 50 40 45 58
4 Medical Devices 0 300 450 400 301
5 Diagnostic Kits 250 350 400 850 340
including Test License
6 Export NOCs 2000 2100 1800 2350 1672
7 Test License 3700 5000 5500 7200 4047
8 Blood Bank License 200 225 280 275 330
9 Import Registration 300 450 400 475 258
10 Import License / Dual 2300 2400 2000 1950 1935
use
11 BE NOC for exports 100 400 600 1300 1070
Total 10160 12945 13370 16945 11061
*Approximate figures
**This does not include other applications like NOC for manufacturing of trial batches of drug, correspondence with
various ministries/deptt. ,sate drug controller authorization ,parliament matters & other misc. letters

Timelines for Approvals

S.NO. APPLICATION FOR TIME IN WORKING
DAYS

A. EXPORT RELATED CLEARANCES

1. EXPORT NOC 10

2. BE NOC
OC FOR
O EXPORTS
O S 28
8

B. OTHER CLEARANCES

3. DUAL USE, RULE 37 & NEUTRAL CODE 20

4. ADDITIONAL INDICATION ETC.(1ST RESPONSE) 45

5. FORM 10 30

6. TEST LICENCE 30
7. A. NEW DRUGS & CLINICAL TRIALS APPLICATIONSFOR OTHER THEN BIOLOGICALS
(1ST RESPONSE) 45
B. NEW DRUGS (MARKETING AUTHORIZATION) APPLICATION FOR BIOLOGICALS
(1ST RESPONSE) 90
C. CLINICAL TRIAL APPLICATION FOR BIOLOGICALS AS PER GUIDANCE DOCUMENT
TO INDUSTRY (1ST RESPONSE) 45

9
 Timelines for Approvals Condt.
S.NO. APPLICATION FOR TIME IN WORKING DAYS

8. FDC (1ST RESPONSE) 45

9. ENDORSEMENT OF ADDITIONAL PRODUCTS 60

ON REGISTRATION FOR MEDICAL DEVICES

10. ENDORSEMENT OF ADDITIONAL PRODUCTS 90

ON REGISTRATION FOR OTHER THAN
MEDICAL DEVICES

11 REGISTRATION 120*

12. REGISTRATION (1ST RESPONSE) 45

*Subject to all clearances including testing by CDTL/CDL as applicable.

Comparison Of Regulatory Timeline Approvals - Clinical Trials

Countries Timeline (Days)

China 300
Brazil 120-140
India 60-80

Czech 80-100

Poland 100-120
Australia/ NZ 70-90
South Africa 70-80
Russia 70-90
Taiwan 80-90
Korea 60-80
Honkong 50-75
Singapore 20-40
USA 20-40

Ernst & Young

10
Myth – Reality About Spurious drugs in India

¾The figures quoted by media range from

10% to 25% of drugs in country being
spurious / counterfeit drugs

¾A study of a samples of drugs tested all

over the country in last 4 to 5
yyears,, reveals that about 0.3%% to 0.4%
% of
around 40,000 samples fall within the
category spurious drugs

Facts and Figures

Year Samples Spurious % age
(2001-2008) Tested Drugs Spurious
Drugs
Detected
2007 2008
2007-2008 39 117
39,117 46 0 117
0.117

Figures from the State 2006-2007 34,738 58 0.166

Drug Controllers - 2005-2006 43,138 152 0.352
spurious Drugs
2004-2005 49,287 144 0.292
detected year wise
2003-2004 40,862 118 0.288

2002-2003 43,138 129 0.299

2001-2002 38,824 96 0.247

11
 Country wide Survey (Year 2008-09)- Spurious Drug

y Study to assess the extent of spurious drugs in country

y Study designed by Indian Statistical Institute, Hyderabad
y Samples
p of 61 various p
popular
p brands from 9 therapeutic
p
categories like anti-TB, Anti allergic, Ant-infective, Anti-
Malarial, Antihistamines etc. were targeted for this study.
y Samples from various parts of the country have been
collected.
y 24,136 samples collected from different parts of country.
y Analysis of 3000 samples drawn randomly is underway
and results are expected by October 2009 end.

Initiatives taken by Govt. of India

y Definition of spurious drugs and penal provision for its manufacture were
introduced in the D&C Act in 1982.

y Recently under the D& C Act (Amendment 2008)

y Penalties for violation of provisions of D & C Act have been enhanced

y Maximum penalty has been enhanced to life imprisonment & fine of Rs 1 Million.
y Certain offences have been made cognizable & non bailable
y Guidelines for implementing the D&C amendment have been circulated to State
Drugs Controllers

y Revised Schedule M became effective from 30th June 2005 to assure that
quality drugs are produced in the country.

y Whistle Blower policy is in process of being implemented

12
 Definition of IMPACT

¾ A medicinal product is counterfeit when there is a false

representation in relation to its identity, history or source.
This applies to the product, its container, packaging or
other labeling information. Counterfeiting can apply to
both branded and generic products. Counterfeits may
include products with correct ingredients/components,
with wrong ingredients/components, without active
ingredients, with incorrect amounts of active ingredients
or with fake packaging.”

Counterfeit Drugs-New Definition at Hammamet ,Tunisia

¾ A medical product is counterfeit when there is a false

representation1 in relation to identity2 and/or source.
source 3
This applies to the product, its container or other
packaging or labelling information. Counterfeit can apply
to both branded and generic products. Counterfeit may
include products with correct ingredients/components4,
with wrong ingredients/components, without active
ingredients with incorrect amounts of active ingredients,
ingredients, ingredients
or with fake packaging.

(Contd.)

13
 Counterfeit Drugs-New Definition at Hammamet Tunisia(Contd.)

Violations or disputes concerning patents must not be confused with

counterfeiting of medical products. Medical products (whether generic or
branded) that are not authorised for marketing in a given country but
authorized elsewhere are not considered counterfeit. Substandard batches
or quality defects or non-compliance with Good Manufacturing Practices/
Good Distribution Practices in legitimate and medical products should not
be confused with counterfeiting.
(1) Counterfeiting is done fraudulently and deliberately. The criminal intent
and/or careless behaviour shall be considered during the legal procedures
for the purposes of sanctions imposed.
(2) This includes any misleading statement with respect to name, composition,
strength, or other elements
((3)) This includes anyy misleading g statement with respect
p to manufacturer,,
country of manufacturing, country of origin, marketing authorization holder
or steps of distribution
(4) This refers to all components of a medical product

CDSCO Initiatives : Year 2008-2012

1. Implementation of CTD Format for biological & qualification of NRA Assessment by

WHO and Introduction of CTD Format for New Chemical Entities

• Streamlining regulatory approval pathway for facilitating development of New

Chemical Entities

2. Infrastructure :
ƒ Shifting of CDSCO HQ, to new building(FDA Bhawan)
ƒ Creation of Pharma Zones with Minilab facility at ports- Delhi, Hyderabad, Mumbai
ƒ Upgradation of 2 Sub Zonal to Zonal Offices and creation of 2 new sub Zonal
offices.
ƒ Shifting of CDSCO West Zone office to new building
ƒ Videoconferencing /Teleconferencing facility in HQ, Zonal offices, Sub Zonal
Offices, ports & CDTL Laboratories
ƒ Creation of Centralized state of art Archiving Facility

3. Manpower
ƒ 144 New posts in various categories have been sanctioned
ƒ 72 new posts were sanctioned in the Year 2008
ƒ This will take the number of Drugs inspectors to 169 , besides 31 assistant drugs
inspectors

14
 CDSCO Initiatives : Year 2008-2012

4. Transparency & Accountability

ƒ Regular posting of approvals on CDSCO website at www.cdsco.nic.in
ƒ Regular posting of guidance document for industry /stakeholders
ƒ Display on 2 LCDs of various approvals at FDA Bhawan
ƒ Turn around time for various applications such as BE, NOC for export ,test licence etc.
ƒ Interactive sessions with stakeholders

5. Clinical Trial
ƒ Mandatory registration of clinical trials in centralized clinical trial registry (www.ctri.in)
w.e f. 15th June 2009
ƒ Registration of CROs , Ethics Committee & Clinical Trial sites
ƒ GCP training of investigators by accredited body.
ƒ Inspection of Clinical Trials
ƒ Building of regulatory capacity in respect of First in Man(i.e. Phase 0/Micro-dosing
studies)
6. Medical devices
ƒ Schedule M III guidelines have been posted on website which are in line with GHTF
ƒ Medical Devices to be taken out from the definition of Drug & Rules to be amended
accordingly

7. National Pharmacovigilance Program

ƒ All medical colleges ,premium medical institutions ,corporate hospitals etc to have a
Pharmacovigilance centre

CDSCO Initiatives : Year 2008-2012

8. Internationals Collaborations with

ƒ WHO
ƒ USA FDA, Health Canada
ƒ Brazil (ANVISA) ,South Africa
ƒ EMEA, AFSSAPS- France
ƒ ICH
ƒ MHRA - UK

9. Nationwide survey of Spurious drugs

10. Inspections
ƒ Overseas manufacturing units
ƒ COPP under WHO GMP Scheme to be issued by CDSCO from 1st October 2009.

11. E-Governance
ƒ LAN / Wi-Fi
Wi Fi connectivity, MIS ,Digitalization of records
ƒ Online submission of all the forms/applications
ƒ Digitalized interactive portal
ƒ Online approvals with Digital signature
ƒ Nearly paperless office.

12. Creation of Central Drugs Authority- Bill under consideration in Parliament.

15
THANK YOU

16