Currently the global pharmaceutical market is estimated at US$ 427 billion with research and development cost estimated at US$ 60-65 billion annually. Two-thirds of this amount i.e., approximately US$ 40 billion, is spent on drug development. Clinical trials involve almost 70% of the time and money of new drug development as the cost of conducting clinical trials for a new drug is approximately US$ 200-250 million. India, home to more than 1.2 billion people, is the second largest pharmaceutical market in Asia estimated at US$ 5.40 billion and is growing by more than 9% annually. Despite this, till March 2013 only 1.5% of the worldwide clinical trials registered at www.clinicaltrials.gov of National Institute of Health, United States of America (USA), were from India. There is a huge potential for clinical trials in India but it is essential that the existing International and National rules and regulations regarding clinical research should be known by potential investigators in ensuring high quality studies. Clinical trials need to be conducted keeping in mind ICH-GCP for clinical trials in India, including the principles of bioethics and other regulatory requirements to safeguard the rights, safety and well-being of the trial subjects. Clinical research has played a vital role in India in the introduction of new drugs and improving health statistics. Today, India is at par with the rest of the world as advancements in this industry have drastically reduced brain drain, therefore, retaining the best of the doctors providing world-class treatment to the Indian patients.(3) The decline in clinical trials in the US has led to an increase in trials across emerging countries, making the industry progressively competitive. The Indian clinical research industry witnessed a slowdown in 2011 due to decline in revenue and the decreasing number of clinical trial approvals further compounded the situation. On the positive side, these challenges geared the industry into action and acted as a channel for the industry, regulatory bodies and other key stakeholders to synergise as well as discuss issues important to the industry. There is huge potential for the clinical research industry in India, which offers attractive opportunities for contract research organisations. The clinical trials industry in India was estimated at $485 million in 2010 by Frost & Sullivan and is anticipated to grow at 17 per cent CAGR from 2009-15, remaining the largest clinical trial market in Asia after Japan. The growth is accelerated not only by the global majors but also the domestic companies that have seen a rapid growth over the past three years(1). India has a varied genetic pool and a significant number of Indians suffer from acute chronic diseases. This can be win-win situation: for patients who don’t get or can’t afford good treatment and pharma companies who need patients to conduct clinical trials to develop new medicines. The cost of a phase I trial is estimat

1. TO STUDY THE NEW REGULATIONS IN CLINICAL TRIAL
MANOJ DAGWAR
GULBERGA UNIVERCITY
MBA IV SEM

2. KEMHRC
MISSION
 “Provide evidence-based, sustainable and rational health
care solutions for the rural population using globally
relevant community-based ethical research”

3. CLINICAL TRIAL
 INTRODUCTION

4. REASONS FOR MEDICATION USE
 Prevention
 Vaccines
 Antimalarial agents
 Antibiotic prophylaxis
 Curative
 Antibacterial
 Oncology drugs
 Antifungal
 Control of Disease Process
 Antihypertensive
 Ant diabetics
 Thyroid agents
 Palliation
 Analgesics
 Oncology drugs

5. CLINICAL RESEARCH AND CLINICAL TRIALS
 What is clinical research?
 Why is clinical research important?
 What are clinical trials?
 What are the phases of a clinical trial?

6. CLINICAL STUDIES
 Phase 1: Efficacy studies on healthy volunteers
 Phase 2: Clinical studies on a limited scale
 Phase 3: Comparative studies on large number of patients
 New Drug Application (NDA): Regulatory review
 Phase 4: Continued comparative studies. Registration and market introduction

7. PHASE 1
Typically involves 20-80 healthy
Emphasis is on drug safety
Goal is to identify major side effects, metabolism and routes of
excretion
About 70% of drugs will pass this phase

8. PHASE 2
Typically involves 100-300 individuals who have the target disease
Emphasis is on effectiveness
Patients receiving the drug are compared to similar patients receiving a
placebo or another drug
About 33% of drugs will pass this phase
Evaluate side effects & effectiveness
Pharmacodynamics
Determine dose response curve

9. Phase 3
Typically involves 1000-3000 patients
Emphasis is on safety and effectiveness
Investigates through well-controlled studies different populations and
different dosages as well as uses new drug in combination with other
drugs
25-30% of drugs will pass this phase
 Confirm effectiveness

10. Phase 4
Post-market surveillance of the drug to continually assess the safety of
the drug
May include incidence and severity of rare adverse reactions, cost-
effectiveness analyses, comparative trials, and quality of life studies
Additional testing as required by the FDA
Continuous monitoring of drug in public use

11. COMPENSATION RULES IN INDIA
 Injury or death unrelated to trial
 Injury or death due to negligence
 Injury or death due to exacerbation of pre-existing disease
 The trial drug fails to produce its efficacy
 Standard drug fails to produce its effect
 Death in the placebo group
 Death in the trial of a drug not meant to treat the disease
 Death due to adverse effects of the IP/standard drug/

12. CHALLENGES OF CONDUCTING CT’S IN INDIA
 Ethical issues
 Quality Issues
 Regulatory issues
 Cultural issues
 Media
 Training/Mentoring
 Informed consent
 Institutionalization and registrations

13. CHALLENGES OF CONDUCTING CT’S IN INDIA
 Approval mechanism
 Transparency
 Inspection and auditing
 Applicability of stringent laws
 Drugs with serious side effects
 Pending actions from the side of Government

14. THANK YOU