The foundation of knowledge-based industry in India was laid down by Information Technology industry and following the footsteps; Clinical Research is fast emerging as another powerful knowledge based industry of the new millennium. Clinical Research is an indispensable part of drug discovery that ensures that the drug, which is to be marketed, is safe and effective.
Clinical research is carried out on healthy volunteers and patients with diseases for which the drug has intended use. It is the most expensive and time-consuming component of drug development.
India is already being looked upon as a hot destination for clinical trials, the advantages that it offers being abundance of Patients with genetic diversity, highly trained medical professionals, skilled manpower and IT enabled infrastructure at a lower cost. The average cost of drug discovery in US is estimated at USD800 million. Research conducted for comparing the drug development cost in India versus other developed countries has clearly spelt that the cost of conducting clinical research in India is much lower as compared to the developed countries.
An estimate of total market of clinical trial conduction either directly or through Contract research organization in India till 2010 is projected at USD 2 billion by many major Pharmaceutical companies.
India has its unique advantages but the challenges too are unique here!
Opportunities
Clinical Trial Guidelines
India has well-defined guidelines for carrying out various phases of clinical trials. These guidelines are in line with the global guidelines on clinical research (ICH-GCP). The various guidelines that governs the conduct of clinical trials in India includes:
i) Schedule Y of Drugs and Cos-metics Act, 1940
ii) Ethical Guidelines for Biomedical Research on Human Subjects, 2000 also known as ICMR Code
iii) Good Clinical Practices, 2001
Patient Population and Wide spectrum of disease
The past experience has shown that in most of the multi-country trials, patient enrolment is rapid in India, thereby speeding up the drug development process. The 20-year-clock on a drug patent starts ticking when a new compound is discovered, not when it is approved. An early completion of drug testing results in the reduction in cost incurred on its development. As a consequence, availability of newer drugs at a lower cost ultimately benefits patients. Moreover such rapid developments will bring better therapies for patients much faster than expected.
Apart from the sheer numbers of patients, there are other compelling reasons why multinationals drug companies are looking at India to test new drugs. Diseases like multi-drug resistant pneumonia, hepatitis B, diabetes, cardiovascular diseases and some cancers are far more prevalent in India than in west. Also testing a drug on different ethnic groups can determine how drugs work differently in various racial groups and among other things, whether different dosages are required in different ethnic populations.
Economy and Economic environment
Clinical trials in India are economic. Drug companies can save up to two - third of overall cost of conducting trials in India compared to the west. The present day economic environment is quite favorable for foreign direct investments. Foreign Direct Investment is over USD 2 billion a year.
Data generation of International standard
The acceptance of data generated from India at all major conferences and journals proves its credibility. India has been a part of the many FDA & EMEA registration studies.
Alignment with GATT/TRIPS/WTO
India became a member of WTO in 1995 and agreed to adhere to the product patent regime by 2005. This has led to a significant growth in pharmaceutical industry (>15%) and increased stakes of MNCs in Indian operations.
Infrastructure
India has a talented pool of Clinical Research Professionals and infrastructure, which includes all super specialties of Medicine, advanced diagnostic tools. Professionals from disciplines like pharmacy, nursing, and lab technology are available in abundance, which could be involved in activities like monitoring of clinical trials, Project management, Study coordinators and data management.
Challenges
Clinical Trial Guidelines
In spite of the well-defined guidelines on clinical trials, the biggest challenge is their implementation and adherence. We do not have a regulatory inspection system in place to monitor the adherence and compliance to these guidelines.
In order to be the part of global clinical research we have to develop a robust Medical Quality Assurance system (MQA), which would ensure the safety of the subjects, involved in clinical trials and also the integrity of data.
Patient Rights and Safety
Prevalence of high illiteracy rates makes poor uneducated masses susceptible to abuse in clinical trials. Such patients can be easily allured to participate in a clinical trial in the name of free treatment. Presently, lack of patient advocacy groups who can be a guardian to these patients' safety and integrity could be a major challenge. Too many languages written and spoken in India also pose a difficulty in preparing authenticated Patient consent form translations, which would cover large patient population.
Data Quality
Hospital records are designated as source documents in clinical trials. This includes patient files, laboratory reports X-rays, ECG reports etc. Most major governmental hospitals have a poor patient data retrieval system due to lack of space, large number of patients and poor environmental control.
The documentation of patient disease as well as treatment is also not adequate to meet the standards of good documentation practices, which is required to ensure data completeness and correctness. It is also important for maintaining an audit trail. There is a lack of centralized records and good archival facilities. Since all GCP based clinical trials need data archival for 15 years it currently poses a challenge.
Infrastructure
The supportive infrastructure like Labs and diagnostics are also not up to the standards of international accreditation. This is a hurdle, as the regulators need supportive data from the labs, which have well defined processes with proper validation, back up and quality control.
Pharmacovigilance
Pharmacovigilance has been defined as " all methods of assessment and prevention of adverse drug reaction". An efficient pharmacovigilance system in place would ensure the safety of the trial subjects while the trial is ongoing and it will also ensure that all relevant safety information is disseminated to participating investigators. The regulatory pharmacovigilance presently is not optimally implemented for adverse event handling and reporting in clinical trials.
Ethical Review Boards
An ethical review board ensures ethical and scientific validity of a clinical research. Various aspects of ethical review board functioning like composition, standard operating procedures that include review process of a research project, voting, decision-making and record keeping are not well defined. They are not matching the standards laid down by Indian as well as international regulatory agencies.
India no doubt is a favorable destination to carry out high-end clinical research in spite of certain challenges. The benefits are large in terms of cost advantages, superior medical care being offered to our patients, interaction of our researchers in India with rest of the world resulting in newer partnerships which will enrich the medical research in India. Moreover it will also create huge employment opportunities for trained professionals competent to carry out clinical research activities.
An active participation is required from Industry, Clinical researchers and governmental agencies involved to act on time to pave a way for an opportunity, that is round the corner.
Fact File- INDIA
- Population - 1,027m (2001)
- Population growth - 1.6%
- GDP growth - 5.1% (2000/01)
- Size of domestic pharmaceutical market: USD 3 billion
- Number of manufacturing units: >20,000
- Market growth rate >10%
- Market share of MNCs: 40%
- Market share of Indian companies: 60%
- Every 6th patient in the world
- Ranked 42 in competitiveness by International Institute for Manage-ment Development
- Ranked 73 in Economic freedom by Cato Institute u
The Authors: Gagan Dua is currently working as Clinical Research Associate, Eli Lilly and company while Sanjay Gupta is Team Leader, Clinical Research in the same organisation