Updated on 29 August 2013
Regulatory changes needed
The large patient pool that India boasts of also adds to its value basket for attracting investments in the domain of clinical research. Currently, India's clinical research market is said to be worth $500 million and with almost 150 million patients suffering from diabetes, cardiovascular or respiratory diseases, and with two million cancer patients, India's disease prevalence data makes it a fertile ground for drug trials. Furthermore, the country has about 600,000 doctors, 45,000 hospitals and around 900,000 beds in both private and public hospitals, with most having electronic medical record facilities.
A 2012 Frost & Sullivan report projected that the clinical research industry would double revenues and cross the $1 billion mark by 2016. The report said, "The large, easy-to-access, treatment-naive population, high degree of available cost arbitrage of up to 30-to-50 percent over the US, and an improved regulatory environment is driving the domestic CRO market, which is growing at 11-to-13 percent."
However, presently the industry is gripped with rising allegations of unethical tests and time-consuming government approvals. In 2011, the industry experienced its first jolts, when reports of increasing number of deaths during trials emerged. During the period of 2005-12, over 2,868 deaths were reported in India, all of which resulted from clinical trials. This brought to light a whole host of issues related to the regulatory system in the country and one of them was the issue of compensation.
Claims were made that the Central Drugs Standard Control Organization (CDSCO), which is India's equivalent of the US Food and Drug Administration (FDA), had been too laid back on the issue of compensation in the case of trial-related injuries and deaths until the controversies erupted. This led to turmoil within and outside the country, damaged goodwill and above all, resulted in financial losses.
Recent policy amendments
The Government of India, in an attempt to make reforms in the regulatory environment, formulated new rules for conducting drug trials in the country. The amendment made to Schedule Y of the Drugs and Cosmetics Rules, 1945, now makes it mandatory for investigators and sponsors to address issues of serious adverse events such as death of subjects involved in trials and mandates grant of adequate compensation in such cases. These new rules also highlight that an independent ethics committees would be set up under medical institutes to monitor ongoing drug trials. It specifies that in case the sponsor fails to provide the proper medical treatment or financial compensation as per the orders, then the authority may cancel or suspend the license of the sponsor to carry out the clinical trials and may even debar it from carrying any clinical trial in future in India.