Your SlideShare is downloading. ×
Scope On Cdm In India Dr  S  K  Gupta
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×
Saving this for later? Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime – even offline.
Text the download link to your phone
Standard text messaging rates apply

Scope On Cdm In India Dr S K Gupta

1,971
views

Published on


0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
1,971
On Slideshare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 1. INDIA AS AN EMERGING DESTINATION FOR OUTSOURCING CLINICAL RESEARCH Dr. S K Gupta Dean & Director General Institute Of Clinical Research, India New Delhi-110037 REQUIREMENTS FOR GLOBAL RESEARCH Infrastructure Regulatory Environment Patient Pool-Genetic Diversity I.P Protection Investigator Availability Bioethics Regulation Cost Advantage 1
  • 2. LANDMARK YEAR: 2005 CLINICAL RESEARCH Phase I clinical trial NCE from Amended abroad in Phase I trial for Schedule Y Pipeline NCE developed in India: Yes Pharmacovigilance Clinical Trial launch Registry launched Product patent regime ICMR/ Bioethics ICH-GCP INFRASTRUCTURE AVAILABLE • Over 200 Medical Colleges • Over 22,000 graduates per year • 15,622 hosp., 903,952 hosp.beds >75% in urban area Clin. Res. • 14000 diagnostic labs Infrastructure • 700,000 scientists and engineering graduates / year • World class medical / lab facilities at secondary / tertiary care centers • Skilled computer savvy biomedical work force • Highly developed IT / ITES IT Support • Motivated & committed personnel • High quality digital connectivity Connectivity • Excellent air/surface transport facilities across country CDSCO 2
  • 3. INDIA : ADVANTAGES • Large No. of specialists in different therapy segments • Medical Training In English Investigators • 600,000 Eng. Speaking physicians • PG training from Europe/US • Treatment Protocols in line with West • Large no. of ICH/GCP compliant Investigators / sites • Large, Diverse, therapy-naïve • Advantage of having 6 out of 7 genetic varieties Patient population • Large pt. pool in acute/chronic disease segment • Increasing no. of pts in life style disorders segment, HIV, Oncology CDSCO Demand-Supply Gap of CR Professionals, 2010 in India 4000 Other Site Staff 400 2000 Invigilator 300 Demand 6000 Supply CRO Staff 1000 1000 Sponsor Staff 200 0 1000 2000 3000 4000 5000 6000 7000 3
  • 4. HUMAN RESOURCE DEVELOPMENT Established in 2004 To meet the challenges 50,000 Professionals DELHI, MUMBAI, BANGALORE AHEMEDABAD AND HYDERABAD DRUG DISCOVERY & DEVELOPMENT R&D investment by Indian Pharma Companies Before patent protection implementation Process research NDDS NCE After patent protection implementation -Expected Process NDDS NCE research Process Research NDDS NCE 4
  • 5. WHY INDIA IS BECOMING A HOT DESTINATION FOR CLINICAL RESEARCH? Clinical trials in India is growing at a 60% AAGR • Crossed USD 100 million in 2004. • By 2010, the industry will spend USD 300M+ on clinical trials in India. Estimated market size of clinical trials in India (USD in mn) More than 150 CRO’s are conducting clinical trials complying TREATMENT NAIVE PATIENTS (DISEASE WISE) 45 million asthmatics 8 million epileptics 30 million diabetics 3 million cancer 18 million hypertensive 1.5 million Alzheimer's 13 million hepatitis C one million 10 million or more HIV schizophrenics patients 5
  • 6. CLINICAL DATA MANAGEMENT ADVANTAGE INDIA Capabilities of Vendors Opportunity From Deals HR capabilities to support Strategic outsourcing of a global large work force function well capitalized & willing to Seek more than cost saving invest Long term contracts committed to innovation Board level oversight Scale & Scope to effect a “Tipping long term high level Point” relationship CLINICAL TRIALS Cost of Clinical trials in USA vis-à-vis in India Study Average US cost (in Indian cost millions) Phase I 20 50% less than the average cost in US Phase II 50 60%less than the average cost in US Phase III 100 60%less than the average cost in US 6
  • 7. CROS CONTRIBUTING FOR OUTSOURCING CLINICAL RESEARCH CROs Can Deliver Quicker CROs Can Deliver Quicker and More Efficient Trials and More Efficient Trials •• Specialized in clinical research and Specialized in clinical research and can generate economies of scale can generate economies of scale 139 140 •• Utilize latest data management tools Utilize latest data management tools 89 66 81 97 & technologies as well as other & technologies as well as other technologies (e.g., patient technologies (e.g., patient recruitment) recruitment) Phase I Phase II Phase III •• Can conduct trials in lower cost Can conduct trials in lower cost Sponsor CRO regions regions •• Reduce time to complete trials* Reduce time to complete trials* – CROs complete trials 30% faster than – CROs complete trials 30% faster than pharma companies* pharma companies* – CROs complete trials in less time – CROs complete trials in less time across phases across phases ADVANTAGE INDIA OVER OTHER COUNTRIES 7
  • 8. DISEASE WISE CLINICAL TRIALS DONE IN INDIA THE PERCENTAGE OF CRO REVENUES FROM BIOTECH FIRMS IS RAPIDLY INCREASING CRO R&D Expenditure Forecast (2000–2007) 100% % of 23% 26% 30% 32% Expenditure 34% 36% 38% 40% Biotech 75% 50% 77% 73% 70% 68% 66% 64% 62% 60% 25% Pharma 0% 2000 2001 2002 2003 2004 2005 2006 2007 Source: Frost & Sullivan, 2003. 8
  • 9. PHASE IV TRIAL MARKET INCREASING DUE TO SAFETY CONCERNS % of Revenue 100% 15.5% 18.8% 22.2% 26.1% Phase IV 75% 39.3% 37.2% Phase III 34.2% 31.1% 50% Phase II 26.2% 24.3% 23.4% 22.2% 25% 19.0% 19.7% 20.2% 20.6% Phase I 0% 2001 2003 2005 2007 CRO Revenues by Clinical Phase (2001–07) Source: Frost & Sullivan, 2003. INDIA BUILDING A TRACK RECORD Clinical Trial Data From India to Achieve an FDA NDA Drug Company Compound Researched Indication US Launch Canagene Hepagam Hepatitis B Jan 06 Eli Lilly Alimta Cancer Feb-04 Eli Lilly Cialis Erectile dysfunction Nov-3 Jannsen Risperidal Psychosis Oct-03 Wyeth Flumist Influenza May-03 Alcon Vigamox Ophthalmic Infections Jan-03 Glaxo Lamictal Epilepsy Jan-03 Novrtis Zelcorm Irritable Bowel Syndrome Jul-02 Pfizer Vfend Fungal Infection May-02 Eli Lilly Xigris Septicemia Nov-01 Santen Quixin Ophthalmic Infections Oct-00 9
  • 10. GLOBAL CLINICAL TRIALS COMPARISON INDIA : CHINA Sr. No. Company Clinical Trial in India CLINICAL Trial in China 1 Astra Zeneca 10 10 2 BMS 17 6 3 Eli Lilly 17 12 4 GSK 22 14 5 J&J 20 13 6 Merck 8 5 7 Novartis 9 6 8 Pfizer 16 5 9 Roche 5 14 10 Sanofi Aventis 15 13 Total 139 98 Clinical Trials from India (www.clinicaltrials.gov.: 15Apr08) 100000 No. Trials (Log transformed) 10000 1000 100 10 1 Phase-1 Phase-2 Phase-3 Phase-4 India 32 165 394 63 USA 6324 11305 5683 2474 All 8540 16878 11662 6142 Phase of trial 10
  • 11. CLINICAL TRIAL ACTIVITIES IN ASIA ALL STUDIES www.clinicaltrials.gov-snapshot: 7 Feb 2008 Countries with more than 100 studies listed Country All Studies % Industry Sponosred Australia 1572 62.72 Chinese Taipei 903 45.29 Japan 732 67.76 Korea 674 72.26 China 643 53.50 India 582 72.16 Singapore 335 68.36 Thailand 327 69.42 Chinese Hong Kong 250 82.00 Philippines 206 93.20 Malaysia 180 93.33 Global Clinical Trials Permitted YEAR No. of Trials 2003 30 2004 50 2005 100 2006 143 2007 264 2008( upto August) 115 Total 702 CDSCO 11
  • 12. GOVERNMENT’S INITIATIVES INCENTIVES No import duty on clinical trial supplies (2003) Exemption from registration requirements for clinical trial supplies (2003) Export of clinical trial related biological specimens allowed, based on protocol approval (2005) Exemption from Service Tax on new Drug testing (2007) RECENT INITIATIVES BY CDSCO FOR PROMOTING ETHICAL CLINICAL RESEARCH • Review of proposal- Time lines • Phase O, Phase-1 and Micro dosing trial- initiatives • Registration CRO’s • Registration of Clinical Trials 12
  • 13. PRIORITIES SET BY CDSCO Establish Single Window clearance for approvals Fix timelines for each application (2-6 Weeks) New Drug application status on the web – Update fortnightly Subject Experts-reviewers – Internal / External Staff & Infrastructure at one site Training CDSCO GOALS FOR CLINICAL TRIALS REGULATION Short Term Goals Year – 2008 • Guidelines for Registration of CROs • Meeting timelines • Registration of CROs • Mandatory registration of clinical trials in centralized clinical trial registry • Allow Phase 0 (micro dosing) studies and phase 1 studies in the country in controlled manner CDSCO 13
  • 14. CDSCO INITIATIVES E-GOVERNANCE- DRUG REGULATORY SYSTEM • * LAN / WAN connectivity of CDSCO campus • * Online submission of all the forms • * Digitalized interactive portal • * Digitalization of records • * Online approvals with Digital signature • * Inbuilt feature would administer spontaneous and random • * Checks to ensure quality ethical standards. • Vision : Paperless CDSCO office CDSCO CLINICAL TRIALS IN INDIA “India’s business and regulatory climates have undergone dramatic change in the past 18 months through passage of a patent bill, regulations updated to harmonize with TRIPs and international standards, and plans for a more US FDA-like regulatory body.” CenterWatch (July 2007) 14
  • 15. CHALLENGES AHEAD • Improvement in Regulatory Framework • Expanding Investigators Pool • Moving from Metro to Mini Cities • Scale up Competence Building • Making India a Vibrant Destination THANK YOU www.icriindia.com 15

×