Percentage of clinical trials in India down from 1.5% as of February 2017 to 1.2% now
India has among the most stringent clinical research regulatory environments in the world
NEW DELHI :
The number of clinical trials being held in India as a proportion of global trials is falling, prompting experts to express concerns over the health implications of this decline.
The percentage of clinical trials in India has come down from 1.5% as of February 2017 to 1.2% now, according to the latest data from the United States National Library of Medicine’s database of global clinical studies.
As on 13 February, 297,101 clinical trials had been conducted in past one year, out of which India is engaged in only 3,618 (1.2%) trials. This despite the fact that the country has 18% of the world’s population and 20% of the global disease burden.
Public health experts claimed that this number is inadequate considering the burgeoning healthcare requirements of India. In fact, they say, more clinical research is needed to develop new and effective medicines and vaccines to tackle its mammoth disease burden and unmet medical needs. “The changing profile of diseases affecting the Indian population, the continuing high prevalence of endemic diseases and the emergence of lifestyle diseases all point to an urgent need for greater investment in research and innovation to address India’s increasing disease burden and the incremental costs associated with it," said Chirag Trivedi, president, Indian Society for Clinical Research (ISCR).
Clinical trials have a patchy history in India. After a parliamentary committee report in 2012 highlighted a strong nexus between drug makers, doctors and some government regulators, the health ministry mandated sponsors of clinical trials to pay 60% of compensation upfront in case of death or permanent disability of the patient. The move led many pharmaceutical companies to head for other geographies for clinical trials.
“Clinical research in India is governed by robust local and global regulations, which make India among the most stringent clinical research regulatory environments in the world. In such an environment we need to encourage, not deter, not-for-profit organizations, institutions and bio-pharma companies from doing more research in India," said Sanjay Mittal, senior director, clinical cardiology and head of research, Medanta hospital.
In July 2018, the World Health Organization (WHO) told the health ministry that with its stringent rules, India will not get sufficient global attention for clinical research. “It is extremely unfortunate that India is lagging behind in clinical trials. However, serious efforts are underway to initiate new strategies to smoothen the hurdles faced by investigators by national organizations, including the Indian Council of Medical Research (ICMR) and the Drug Controller of India (DGCI)," said Ravi Mehrotra, director, ICMR-National Institute of Cancer Prevention and Research of the Department of Health Research.