CLINICAL TRIALS IN INDIA: PATIENT AVAILABILITY
Indian habitat is genetically more diverse than that of the western countries. A population of more than 1 billion makes India a very relevant place for conducting clinical trials. Moreover, India has a very large pool of variety of diseases. - cancer, diabetes, blood pressure and AIDS being the most common amongst them. Almost each family in India has at least one diabetic and one blood pressure patient. There is a bulk of patients who are willing to participate in clinical trials in India for common diseases as they are not so fatal. However, for fatal diseases like, cancer and AIDS also, people are participating in clinical trials in India. As, till now, there is no perfect cure for such diseases, people want to try and go for new and improved drugs in the hope of getting benefits from new medicines. People who are in critical stages of the disease mostly go for any hope that is capable of curing them. As there is a large population suffering from these disorders, clinical trials in India are always welcomed.
Moreover, the drugs which are in trial stages are not expensive, this adds to the value of clinical trial drugs. As India is a developing country and majority of the population belongs to the middle income group, cheaper treatment is always preferred.
India's pharmaceutical regulatory bodies are now even more mature to take care of the ethical issues related to clinical trials as the awareness level due to lack of literacy has not been very remarkable so far. Regulatory bodies are now much more experienced and careful for the consent forms and better understanding of patient and clinical trials in India. Regulation ensures that the patients are well aware of the clinical trials which they have to undergo and make the patient understand about the risks and benefits associated with the use of drug. In other words, their consent must be genuinely informed. India has the largest pool of patients with a variety of diseases. Asians are considered to have the most resistant immune system and hence the healthy volunteers are mostly not very sensitive for trial drugs that can lead to immediate adverse reactions. This is a boon to the companies who want to conduct clinical trials in India. Moreover, people are more participative owing to their need of cheaper treatment plus well trained doctors.
On the other hand, China is a competitor of India in terms of patient availability and variety of diseases. But, the regulatory practices are not reliable enough to have a blind faith on patient availability. Hence, the ethical issues there are always doubtful.
US comes under the list of developed countries and hence the scope of conducting clinical trials for pre approved drugs cuts down, as the people there are very conservative and not willing to take risks, especially when it comes to their health. They rely more on proven methods of curing diseases. Also, there is no such need of cheaper treatments and education. Thus, besides plethora of diseases found in the US, the clinical trials are not invited a lot.
