Clinical trials in India
Since the early 2000s there have been international discussions from science, medicine, and business sectors which observed that India is both an attractive and challenging place to conduct medical research.
[4] In the years around 2010 there were various scandals in media and popular discussion in which companies conducted clinical trials in unethical ways.
Among the responses, some say that the clinical trials are safer for participants, and others say that the new rules favor large domestic and international companies over other stakeholders.
[9] A study examining all registered ethics committees in 2017 reported that few of them were in academic medical institutions, which is the global norm and desirable for such organizations.
[17] The study recommended improved research participant education as a way to make the management of trials more ethical.
[18] One 2015 audit of 5 years of trials at a single site found that the expected percentage of people invited to participate declined to do so.
[19] An evaluation of about 50 clinical trials in 2007-08 found that the reported results had higher than expected rates of false positive errors due to the statistical methods the researchers used.
[24] Many potential research participants in India had not previously had medical treatment, and clinical trials get better data from such people.
[24] India also has a well trained workforce and many research sites which met international good clinical practice standards.
[25] However, to make sense of any such reports from India, then researchers have to adapt the instructions for local Indian culture.
[27] There was perception in the research community that the media had usefully brought public scrutiny of the ethics and conduct of clinical trials.
[31] A 2011 paper noted that low operational costs, improved government regulation, and existing business infrastructure have made India increasingly attractive as a place for foreign companies to conduct clinical trials.
[32] Some researchers study global practices for managing clinical trials and apply lessons learned to multiple countries at once, with India being among them.
[36] A characteristic of a healthy clinical trials sector in a country is prioritizing the most urgent health concerns of the population.
[22] This low rate of domestic drug approval demonstrates that the research is not actually a medical benefit to the local population in India.
[39] A 2008 report described the entry of multinational companies into India for clinical trials research as a frenzy.
[40] At the time there was a perception that the industry was going to grow fast for the foreseeable future in a way that favored the research investor.
[41] The investment from foreign companies has resulted in more education, professional training, and jobs in the clinical research sector.
[41] However, there has been an obvious sudden increase of influence by both foreign and domestic large companies as this research field has developed.
[41] The establishment of the Pharmacovigilance Program made India a more attractive international destination for foreign companies to bring clinical trials research.
[44] Because of the risks, that paper advised that foreign countries would not gain benefit from outsourcing clinical trials to India.
[47] Among all that growth, a major concern was establishing regulation to improve the ethics and integrity of clinical research in India.
[51] The staff who were there were working under a misguided mandate to "meet the aspirations … demands and requirements of the pharmaceutical industry", which was an error and a conflict of interest against protecting the health of the public.
[24] The researchers must report serious adverse events quickly to the study sponsor, the ethics committee, and the government regulator.
[24][53] All trials will comply with publicly available payment formulas for calculating how much money to give in case of someone dying or experiencing any other serious adverse effect.
[24] In 2018 the government established a process for approving drugs in India, without clinical trials, in exceptional circumstances such as an epidemic.
[58] A 2009 report described how innovation in phase 1 cancer research trials could have a big impact on Indian health.
[59] Various studies in the United Kingdom have described how British researchers can make trial participation easier for South Asian people living in the UK.
[60][61] A 2011 report encouraged teaching clinical research in the curriculum of medical students to prepare them to conduct trials.
[62] A 2019 survey found that respondents in India were cautious in saying that they would approve of clinical trials related to the sexual health of adolescent girls.
