The question – whether India should participate in global clinical trials – has been on the horizon since 2005, when regulations for clinical trials were amended.
The need for clinical trial has become a burning question with media, parliament, and NGOs voicing concerns about rights, safety well-being of clinical trial participants.
A writ petition has requested the supreme court of India to direct the government that 1) no clinical trials of psychiatric patients and children shall take place till suitable guidelines are framed and 2) that where effective treatment is available, no placebo trial should be conducted on patients.
In March 2012, a question was asked in parliament: What steps being taken by Government to stop drug trials on patients in the future? Although government denied any move to stop clinical trials, the tone and tenor of public discussions appears to be unfavourable to clinical trials in general and global trials in particular. In such an emotionally charged atmosphere, it is desirable to consider the other perspectives - scientific and medical need for clinical trials for Indian population.
One of arguments against global clinical trials is that they are not conducted in diseases endemic to India – communicable disease such as tuberculosis and malaria but in non-communicable conditions prevalent in Western countries – cancer, cardiovascular, neurological, psychiatry etc. However, this argument masks the current reality of India’s disease profile.
Disease profile
Several recent reports from World Health Organization (WHO), INDIA National Health System Profile 2008 and National Commission on Macroeconomics and Health 2005 have discussed the current Indian health scenario. These data suggest that the range and complexities of health issues are substantial with the equal presence of both communicable and non-communicable diseases.
The dominant communicable diseases are infectious and parasitic diseases, respiratory diseases, maternal conditions, perinatal conditions and nutritional deficiencies.
Non-communicable diseases are cancer, diabetes mellitus, neuropsychiatric disorders, sense organ disorders, cardiovascular diseases, respiratory diseases, digestive diseases, musculo-skeletal diseases, congenital anomalies, oral diseases and other non-communicable diseases.
The current prevalence and future estimate for 2015 are desorbed in the table (Ref: National Commission on Macroeconomics and Health 2005)
It is estimated that India's disease burden will increase significantly due to non-communicable diseases.
Cardiovascular diseases and diabetes will increase two-fold and cancers will rise by 25 per cent. Mental health illnesses are anticipated to rise due to stress on account of frequent disruptions in incomes, unemployment, lack of social support systems etc.
One assumes that these communicable diseases largely affect the rich, affluent people from higher socio-economic strata. There is limited direct evidence available in India on the risk of non-communicable diseases, by socio-economic status. However, the current data from National Commission suggests that the poor are no less at risk.
The non-communicable diseases contribute to higher proportion – 53 per cent of deaths (cardiovascular 29 per cent and others 24 per cent). .
The cancer death rate (per 100,000 population) is 49 i.e. cancer kills 4.9 lakh Indian annually. The deaths due to cardio-vascular diseases affect 188 per 100,000 population or 1.88 million Indians.
Also India has a high burden of mental health – psychiatric problems. Most of these illnesses have serious consequences. Stopping trials for psychiatric conditions would have disastrous consequences. Efforts have to be made to find therapeutic solutions for both communicable and non-communicable diseases.
New drug resources
One important consideration in Indian setting is access to affordable medicines. National Commission on Macroeconomics and Health commission, whilst discussing issue of high price of globally patented drugs, recommends step up publicly supported R&D, encouraging public agencies, universities and private companies to develop new drugs. However, this approach is still in infancy and unlikely to meet the expectation of providing affordable new drugs over next few years. This means we still have to depend on pharma industry for new drugs.
The pharma resources are Indian Pharma and Western multinationals. Although one would expect Indian pharma to focus on India’s prime need – drugs for communicable disease, the drug discovery pipeline of Indian pharma by and large covers non-communicable disease – cancer, diabetes, hypertension, , cognitive disorders, parkinsonism, rheumatoid arthritis, COPD, asthma, obesity, osteoporosis etc.
The Indian R & D pipeline has around 90 compounds of which 60 are in pre-clinical stage and 20 in Phase I. (The Indian Drug Discovery And Development Pipeline Differding Consulting 3 Jan 2012). Considering that drug development requires over 10-12 years, and success rates are low, Indian pharma would not be able to provide new drugs in near future.
The other resource is new drugs developed by global pharma companies. There are two approaches for India:
1) Participate in global clinical trials and accept data generated in Indian patients for supporting registration of new drug in India
2) Follow the old pre-2005 approach of local Phase III trials to permit marketing in India.
It appears that either approach essentially results in same scenario – participation in clinical trial of a global pharma company.
Of course, it is essential that the regulatory and ethical process are strengthened to protect the rights, safety and well being of the clinical trial participants. Similarly, it is essential that the regulatory process is made transparent and time bound so as not to delay introduction of global new drugs in India.
The author is President, Clininvent Research Pvt Ltd