this ppt talks about the clinical trends and growth in past 10 years and regulatory aspects of Clinical trials in India

1. Presented By-
Nayan Jha
M.Pharm( DRA)
Poona College of Pharmacy
Bhartiya Vidhyapeeth, Pune
Present Scenario of
Clinical Trials in
India: Waking the
Sleeping Tiger

2. Introduction
• India is one of the major destination for conducting clinical
trials. The Drug Controller General of India (DCGI) is the
governing body responsible for all pharmaceutical-research
and regulatory issues in India.
• Clinical trials in India are controlled by 3 regulatory guidelines.
• The presentation is planned to see the scenario of clinical
trials and their trend over the last 10-12 years and also in view
of new regulatory guidelines.
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3. Contents
1. What is clinical trial?
2. World’s clinical trial status
3. Why India as a destination for clinical trial?
4. Growth of clinical trial in India
5. Achievements and initiatives
6. Challenges
7. Clinical trial quick facts
8. Conclusion
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4. 1. What is Clinical trial ?
• “Any investigation in human subjects intended to discover or verify the clinical,
pharmacological and/or other pharmacodynamic effects of an investigational product(s),
and/or to identify any adverse reactions to an investigational product(s), and/or to study
absorption, distribution, metabolism, and excretion of an investigational product(s) with
the object of ascertaining its safety and/or efficacy”. (according to ICH-GCP 1.12)
• Clinical trial has four phases:
PHASE 1
(Human
Pharmacology
trial)
PHASE 2
(Exploratory
trial)
PHASE 3
(Confirmatory
trial)
PHASE 4
(Post
Marketing
trial)
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5. Overview of Clinical trial
International Clinical Trial Day celebrated each year on/near 20th May in
order to celebrate the day James Lind started the famous clinical trial,1747
(www.jameslindlibrary.com)
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6. Drug Discovery and Development
*SOURCE- R&D Cost Study Briefing, Boston
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7. 2. World’s Clinical Trial Status
Geriatric trials have been on spotlight in countries like USA & Japan.
Paediatric trials have been on spotlight in countries like Canada and Australia.
SOURCE- https.//ClinicalTrials.gov
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8. 3. Why India as a destination for clinical trial?
Investigators
• Large no. of specialists in different therapy segments
• Medical training in English
• Treatment protocols in line with west
Patient Population
•Large, diverse, therapy-naıve
•Large pt. pool in acute/chronic disease segment
•Increasing no. of pts in life style disorders segment, HIV, oncology
Clinical Research infrastructure
• Over 200 medical colleges
• Over 22,000 graduates per year
• World class medical/lab facilities at secondary/tertiary care centres
• Skilled computer savvy biomedical work force
Connectivity
• High quality digital connectivity
• Excellent air/surface transport facilities across country
SOURCE- Dr. Surender Singh,ClinicalTrials New Horizon—India
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9. *SOURCE- McKinsey report, CDSCO
Cost of carrying out Clinical research in India, Russia, China is half the
amount required in USA.
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10. 4. Growth of clinical trial in India
*SOURCE- Clinical Trial Registry; www.clinicaltrials.gov
*SOURCE- Mc kinsey report,2016
• The Indian pharmaceutical industry is
growing at an annual rate of 11 % while
the clinical research industry is growing an
annual rate of whopping 84 %.
• India ranked third in the vaccine trials
among the study regions next to US and
EU.
• The top 10 diseases with maximum
ongoing trials in India was found to be in-
cancer, diabetes, coronary artery
disease (CAD), asthma, chronic obstructive
pulmonary disease (COPD), epilepsy,
hypertension, schizophrenia, heart failure,
HIV, malaria.
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11. 4. Growth of clinical trial in India
• 1.3% population growth/year- rise in trials 20% by 2020.
Phase wise distribution of studies done by
various systems of medicine
State-wise maximum number of studies are done in - Maharashtra
Gujarat
Tamil Nadu
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No. of clinical trial approval

12. 5. Achievements & Initiatives
Evolution of regulatory changes in India (2005–2017 as relevant to clinical trials)
YEAR NATURE OF REGULATION
2005-2006
• Amendment of 1988 version of
Schedule Y
• Next revision was done in 2006
2007
• CDSCO disqualifies NRA
(assessment in respect of
Regulatory Control over
vaccines discovered and
manufactured in the Country).
2009
• CDSCO qualifies NRA
• Registration of Clinical trial to
CTRI was done mandatory from
15th June.
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13. YEAR NATURE OF REGULATION
2013
• Introduction of SAE analysis and
timelines for reporting SAEs
• Introduction of compensation for clinical
trial related injury or death
• Various requirements conditions for
conduct of clinical trials included
• Registration of ECs with DCGI made
mandatory
• Introduction of AV recording of informed
consent process of clinical trials
• Independent ECs to oversee
Bioavailability and Bioequivalence studies
(BA/BE) for approved drug molecules
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14. YEAR NATURE OF REGULATION
2016
• No approval needed from DCGI when-
a) A 'new' drug undergoing a clinical trial for investigator
initiated studies (IIS) .
b) Addition of new trial site or investigator
• GCP Inspection checklist released by CDSCO
• Diagnostic laboratories & research centres can import/export
biological material without the need for an import/export license
• SUGAM- online applications for clinical trials
• Uplift of restriction of Investigator to only 3 trials rule
• New Amendment of DACA Rules,1945 came on 31st Dec
2017
• ICMR came up with the newly revised guideline “Ethical Guideline for
Biomedical Research on Human Participants” in October
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15. 6. Challenges
New regulations bought in
severe challenges
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16. 7. Clinical Trials Quick Facts
• RECENTLY APPROVED DRUGS IN INDIA-
Date of Approval Drug Disease
7/12/2017 Macitentan tablet Pulmonary arterial hypertension
24/11/2017 Arteolane maleate+ Piperaquine
phosphate Dispersible tablet
Acute Uncomplicated P.falciferum
& P.vivax malaria
10/11/2017
Tenofovir Fumarate capsule
Chronic Hepatitis B
• TOP 3 CRO’S IN INDIA-
QUINTILES IMS
HOLDINGS, INC.
PAREXEL International
Corporation
LABORATORY
CORPORATION OF
AMERICA HOLDINGS
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17. .
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• As of July 2014, the New Drug Advisory Committees (NDACs) established in
2011 were renamed Subject Expert Committees (SECs).
• In May 2017, FDA Office of International Programs held its 1st joint training
workshop for Indian regulators, academic representative and industry on ethical
standards for clinical trials.
• In August 2017, Government proposes abolishing clinical trials on proven drugs.
• Mylan and Biocon’s biosimilar trastuzumab, to be sold under the name Ogivri,
gets first US-FDA approval for the treatment of breast cancer or stomach cancer
• GlaxoSmithKline Wins FDA Approval for Shingles Vaccine “Shingrix”.

18. • At present, the Indian environment is again becoming conducive to
clinical trials. However, it is essential that all stakeholders work
toward common goal of conducting quality trials which assure
human subject protection while ensuring data integrity of the trial.
• The recent regulatory amendments call for a fresh breath of air in
the clinical research industry.
8. Conclusion
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‘GREAT FUTURE OF CLINICAL TRIALS
IN INDIA’