A database maintained by the US National Library of Medicine states that there are 2,66,901 clinical trials being conducted in the world. India is the 2nd most populous country in the world; it bears 20% of the burden of diseases and 1.4% of the clinical trials of the world take place in India. Given the size of the Indian population and the favorable conditions present for conducting trials in India, the figure can be improved upon.
Clinical trials in India saw an upsurge after India became a signatory to TRIPS (Trade related Intellectual Property Rights) in 2005. The period from 2005-2010 saw a massive increase in the number of clinical trials conducted by domestic as well as by foreign pharmaceuticals. Pharmaceuticals employ CROs (Contract Research Organizations) while outsourcing clinical trials to manage their operations in another country, to cut down on costs. The major global CROs operating in India are – IQVIA, PPD, Paraxel and the major domestic players are - Siro Clinpharm, Clininvent.
The main reasons for India becoming a preferable destination for outsourcing of clinical trials were; availability of cheap skilled English speaking professionals to conduct the trials, large patient pool with diverse genetic conditions, low cost of doing business, timely completion of trials and significant market opportunities. The cost of conducting a clinical trial in India (and other BRICs nations) is almost half the cost of conducting a clinical trial in the US, providing a cost effective alternative to Pharmaceutical companies. However, many cases of financial inducements offered to patients were reported which led to patients entering multiple trials at once, skewing the accuracy of the test results and leading to harmful effects for the participants. The exact number of deaths caused by clinical trials in India has been reported differently by various organizations because of poor documentation and failure in determining the exact cause of death.
Under pressure from NGOs and various organizations, the Indian government approached the Supreme Court in 2013 which halted the progression of 162 trials in the country. On advice of the Supreme Court, the regulatory framework regarding clinical trials was improved which led to a fall in the participation of global pharmaceuticals in conducting clinical trials in India. The period from 2013-2015 saw a major setback for clinical trials in India because of the new, stricter regulations which resulted in longer waiting periods while seeking approval; major pharmaceuticals such as Biocon even considered shifting their operations to other countries. The media uproar created regarding the death of individuals participating in these trials may have been misplaced because often, the figures fail to differentiate between deaths of patients during a clinical trial and deaths of patients caused by a clinical trial. Determining the exact cause of death or injury is imperative before allocating compensation to the victims and participants.
In 2016, the clinical industry saw a revival because of simplification of regulatory processes which cleared a lot of the ambiguity surrounding the approval process. These reforms have led to increased transparency in the system and removed some of the unnecessary procedural delays while getting clearances. Also, the companies only need to pay compensation up to the point where the drug resulted in the adverse reaction in the patient in the trial. The future for clinical trials appears to be bright and experts have predicted growth in the sector in coming years because of the regulations and the pro foreign investment stance of the government of India.
Some of the problems that need to be addressed are; the participants do not always get their compensation in case of any injury or loss of life. The trials mostly focus on non-communicable diseases of a western bias and do not look to fight the problems more prevalent in India. Appropriate legislation should ensure that the treatments devised through clinical trials conducted in India be made available to Indian citizens at discounted rates, or for free. Proper records of patients enrolling in clinical trials should be maintained so that patients do not enroll in multiple trials at once, which can have adverse health effects for the patients.