regulatory india

8/8/2019 Regulatory India

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DRUG REGULATORYFRAMEWORKPresentation By

&

NEW INITIATIVESDebasish PandaJoint SecretaryMinistry of Health &Family WelfareGovernment of India

INDIA

Snapshot - Indian Pharma Industry

Indian Pharmaceutical Market ~US $ 18bn

Import (2008-09 )US$ 2.7 Bn

-

8% global Production & 2% of World phama Market

Bulk Drug Production > 400 APIs

Export of Biotech products ~US $763M

Biopharmaceuticals ~ US $ 600 M

Manufacturing Facilities 119 US FDA Approved

Largest Number of Manufacturing Facilities outside US153 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)


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Final ANDA Approvals Granted in US (2008) - Countrywise

Country Numbers

USA 169India 132

Israel 40

Germany 25

Canada 24

Switzerland 19

Jordan 11

Other 25 Source: Thomson Scientific

Indian Vaccine & Biopharma Industry

400 organized pharma sector

200 companies in biotech Sector

Growth rate is 37% in 2006-07

Total production of biopharmaceuticals is >US$ 1Bn


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Indian Pharmaceutical Industry: EXPORTSIndian Pharmaceutical Industry: EXPORTS

6

7

81980-81

1990-912000-01

2001-02 5.8186.011

7.30

2

3

4

5

2002-03

2003-04

2004-05

2006-07

2007-08

2008-09

2.05

2.813.42

4.121

USD

Billion

2.850

0

1

1980-811990-912000-012001-022002-032003-042004-05 2006-072007-082008-09

0.1840.009

Trade with Africa Countries

USD Bn % Growth

Total Pharma Export 5.66 12.78

r can ountr es . .

Share of Exports to

African Countries 13.53%


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TOP 5 countries Sorted by Share of Market Region Wise

Southern Africa North AfricaSouth 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 AfricaKenya 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 AfricaChad 4.18% Gabon 3.75%Cameroon 33.31% Congo Rep 0.68%

Equtl Guinea 0.28

Vaccines Exported to 151 Countries


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BharatBiotechInternationalLimited HepatitisB(recombinant)(RevacB+)

HaffkineBioPharmaceuticalCorp.Ltd. OPV(frombulksuppliedbyBiofarma,Indonesia)

NovatrisVaccinesandDiagnosticsS.r.l RabiesIndia,(FormerlyChironBehring)

WHOPREQUALIFIEDINDIANVACCINEMANUFACTURERS

(AsofJune,2009)

PanaceaBiotech DTwP Biofarma HibNovatris (1dose)(EASYFOUR)DTwP Biofarma HepatitisB P.H.B.(1dose) (ECOVAC)

DTwP BiofarmaHepBP.H.B. HibP.H.B. (1dose) (EASYFIVE)

HepatitisB(EnivacB)

OPV(frombulksuppliedbyBiofarma,Indonesia)

OPV(frombulksuppliedfromChiron,Italy)

SerumInstituteofIndiaLtd. BCG,DT,dT,DTwP,DTwPHepB,HepB(recombinant),Hib,TT,MR,

MMR,Measles,Rubella

ShanthaBiotechnicsPrivateLtd. HepatitisB(recombinant),DTwPHepB(Shantetra), TT(ShanTT),DTwPHepatitisBHib(Shan5)(1doseand10doses)

ZydusCadila Rabies

India Well defined Drug Regulatory System

Govt. of IndiaMinistry ofHealth & Familywelfare

Ministry ofChemicals &fertlizers

Ministry ofCommerce

Patent Office

Ministry ofscience &Technology

CDSCO

DCGI DTABEnforcement &GMP audit Div

Quality Control

Pharmaceuticals

NPPA

Controller Generalof patents DBT

CSIR Labs

-

Registration Div

New Drugs Div.

Pharmacovigilance

Trainings


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CDSCO North Zone (Ghaziabad)

CDSCO, HQ

CDSCO Geographical Location of 6 Zonal Offices

Mumbai

New Delhi

Kolkata

.

CDSCO West Zone (Mumbai)

CDSCO South Zone (Chennai)

CDSCO East Zone (Kolkata)Ahmedabad *

New Zonal Offices Ahmedabad & Hyderabad

Chennai

Hyderabad- :Port Offices/Airports : 7Laboratories : 6

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-DNAproducts & 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


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Functions of State Licensing Authorities

Functions of State Licensing Authorities

Licensing of Manufacturing Site for Drugs including API andFinished Formulation

Licensing of Establishment for sale or distribution of Drugs

Approval of Drug Testing Laboratories

Monitoring of Quality of Drugs and Cosmetics marketed in thecountry

legal provision

Recall of sub-standard drugs

CDSCO -Number of Applications received/processed

From Year 2005-09

25000

10000

15000

Series 1

Series 2

o

.ofApplications

10160

13370

16945

12945

11061

Expectedapplications by

Year 2009 end

0

2005 2006 2007 2008 2009Jan-June

Year(Jan-Dec)


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S.No Subject Year

2005*

(Jan-Dec)

Year 2006*

(Jan-Dec)

Year 2007*

(Jan-Dec)

Year 2008*

(Jan-Dec)

Year 2009

(Jan-June)

1 New Drug Applications 1200 1500 1600 1750 920

2 Global Clinical Trials 100 170 300 350 130

Statuso variouscategorieso app icationsreceive processeFromJan2005to30th June2009

3 Vaccines and Biotech 10 50 40 45 58

4 Medical Devices 0 300 450 400 301

5 Diagnostic Kits

including Test License

250 350 400 850 340

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

use

2300 2400 2000 1950 1935

11 BE NOC for exports 100 400 600 1300 1070

Total 10160 12945 13370 16945 11061

*Approximate figures**This does notinclude other applicationslike NOCfor manufacturing of trial batchesof drug, correspondence withvarious ministries/deptt. ,satedrug controller authorization ,parliament matters & othermisc. letters

Timelines for ApprovalsS.NO. APPLICATION FOR TIME IN WORKING

DAYS

A. EXPORT RELATED CLEARANCES

1. EXPORT NOC 10

2. BE NOC FOR EXPORTS 28

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 DOCUMENTTO INDUSTRY (1ST RESPONSE) 45


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S.NO. APPLICATION FOR TIME IN WORKING DAYS

8. FDC (1ST RESPONSE) 45

Timelines for Approvals Condt.

9. ENDORSEMENT OF ADDITIONAL PRODUCTS

ON REGISTRATION FOR MEDICAL DEVICES

60

10. ENDORSEMENT OF ADDITIONAL PRODUCTS

ON REGISTRATION FOR OTHER THAN

MEDICAL DEVICES

90

11 REGISTRATION 120*

12. REGISTRATION (1ST RESPONSE) 45

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

Countries Timeline (Days)

China 300

Brazil 120-140

India 60-80

Comparison Of Regulatory Timeline Approvals - Clinical Trials

Czech 80-100

Poland 100-120

Australia/ NZ 70-90

South Africa 70-80

Russia 70-90

Taiwan 80-90

Korea 60-80Honkong 50-75

Singapore 20-40

USA 20-40

Ernst & Young


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Myth Reality About Spurious drugs in India

The figures quoted by media range from

10% to 25% of drugs in country being

A study of a samples of drugs tested allover the country in last 4 to 5ears reveals that about 0.3% to 0.4% of

around 40,000 samples fall within the

category spurious drugs

Facts and Figures

Year(2001-2008)

SamplesTested

SpuriousDrugs

% ageSpurious

DrugsDetected

- , .

2006-2007 34,738 58 0.166

2005-2006 43,138 152 0.352

2004-2005 49,287 144 0.292

2003-2004 40,862 118 0.288

Figures from the StateDrug Controllers -spurious Drugsdetected year wise

2002-2003 43,138 129 0.299

2001-2002 38,824 96 0.247


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

Study to assess the extent of spurious drugs in country

Study designed by Indian Statistical Institute, Hyderabad Samples of 61 various popular brands from 9 therapeutic

categories like anti-TB, Anti allergic, Ant-infective, Anti-Malarial, Antihistamines etc. were targeted for this study.

Samples from various parts of the country have beencollected.

24,136 samples collected from different parts of country.

and results are expected by October 2009 end.

Initiatives taken by Govt. of India

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

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

Drugs Controllers

Revised Schedule M became effective from 30th

June 2005 to assure thatquality drugs are produced in the country.

Whistle Blower policy is in process of being implemented


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Definition of IMPACT

A medicinal product is counterfeit when there is a falserepresentation in relation to its identity, historyor source.This a lies to the roduct its container acka in orother labeling information. Counterfeiting can apply toboth branded and generic products. Counterfeits mayinclude products with correct ingredients/components,with wrong ingredients/components, without activeingredients, with incorrect amounts of active ingredientsor with fake packaging.

Counterfeit Drugs-New Definition at Hammamet ,Tunisia

A medical product is counterfeit when there is a false.

This applies to the product, its container or otherpackaging or labelling information. Counterfeit can applyto both branded and generic products. Counterfeit mayinclude products with correct ingredients/components4,with wrong ingredients/components, without active

, ,or with fake packaging.

(Contd.)


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

Violations or disputes concerning patents must not be confused withcounterfeiting of medical products. Medical products (whether generic or

branded) that are not authorised for marketing in a given country butauthorized elsewhere are not considered counterfeit. Substandard batchesor quality defects or non-compliance with Good Manufacturing Practices/Good Distribution Practices in legitimate and medical products should notbe confused with counterfeiting.

(1) Counterfeiting is done fraudulently and deliberately. The criminal intentand/or careless behaviour shall be considered during the legal proceduresfor the purposes of sanctions imposed.

(2) This includes any misleading statement with respect to name, composition,strength, or other elements

3 This includes an misleadin statement with res ect to manufacturercountry of manufacturing, country of origin, marketing authorization holderor 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 byWHO and Introduction of CTD Format for New Chemical Entities

Streamlining regulatory approval pathway for facilitating development of NewChemical Entities

2. Infrastructure : Shifting of CDSCO HQ, to new building(FDA Bhawan) Creation of Pharma Zoneswith Minilab facility at ports- Delhi, Hyderabad, Mumbai Upgradation of 2 Sub Zonal to Zonal Offices and creation of 2 new sub Zonal

offices. Shifting of CDSCO West Zone office to new building Videoconferencing /Teleconferencing facility in HQ, Zonal offices, Sub Zonal

Offices, ports & CDTL Laboratories

Creation of Centralized state of art Archiving Facility

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

inspectors


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4. Transparency & Accountability Regular posting of approvals on CDSCO website at www.cdsco.nic.in Regular posting of guidance document for industry /stakeholders

Display on 2 LCDs of various approvals at FDA Bhawan Turn around time for various applications such as BE, NOC for export ,test licence etc. Interactive sessions with stakeholders


5. Clinical Trial Mandatory registration of clinical trials in centralized clinical trial registry (www.ctri.in)

w.e f. 15th June 2009 Registration of CROs , Ethics Committee & Clinical Trial sites GCP training of investigators by accredited body. Inspection of Clinical Trials Building of regulatory capacity in respect of First in Man(i.e. Phase 0/Micro-dosing

studies)6. Medical devices

Schedule M III guidelines have been posted on website which are in line with GHTF Medical Devices to be taken out from the definition of Drug & Rules to be amended

accordingly

7. National Pharmacovigilance Program All medical colleges ,premium medical institutions ,corporate hospitals etc to have a

Pharmacovigilance centre

8. Internationals Collaborations with

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


MHRA - UK

9. Nationwide survey of Spurious drugs

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

11. E-Governance

LAN / Wi-Fi connectivit MIS Di italization of records Online submission of all the forms/applications Digitalized interactive portal Online approvals with Digital signature Nearly paperless office.

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


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