Indian clinical research industry shaping up

By Emilie Reymond

- Last updated on GMT

Related tags: Clinical trials, Pharmacology, Pharmaceutical industry, India

India's clinical research industry took on more shape this week
with the launch of the Indian version of the Association of
Clinical Research Professionals (ACRP) and the government's
proposed new regulations on clinical trials conducted in the
country.

Pharma services provider Bilcare Research, the Indian company at the root of the creation of the Indian ACRP, said yesterday it expects the new body to be a gateway for quality clinical research training in the Asian region. The company also launched yesterday its first training centre at Pune, India, dubbed Bilcare Research Academy which, alongside ACRP, will provide training to hospitals, contract research organisations (CROs) and other players in the clinical research arena. "The ACRP-Bilcare academy will bridge the gap of a long awaited qualitative manpower requirement and practices across the country and parts of Asia. This partnership aims to uplift the clinical research infrastructure in the Asian region,"​ said Mohan Bhandari, managing director of Bilcare Research. "Forthcoming US elections may trigger for India's $200m (€150m) clinical trials industry which now accounts for just one percent of the world market. Democrats are keen to empower the government to negotiate drug prices directly with pharmaceutical companies as well as to provide for re-importation of drugs,"​ said Thomas Adams, CEO of ACRP. "If accomplished, these measures could reduce the profitability of big pharma, which would impact their resources for inventing new drugs. In such a scenario, they would be forced to offshore their clinical trials to cost-effective regions, particularly to India and hence there is a need of capacity building at this stage, which will be provided by Bilcare-ACRP's common initiative,"​ he explained. The initiative comes at a decisive time and could support the country's clinical research as the Indian government seems to want to get tougher on the regulation of clinical trials with a new set of rules now ready to be proposed to lawmakers. The country's health ministry said it plans to regulate clinical research activities under the authority of the Central Drugs Authority (CDA) - the Indian drug regulator - with a draft bill likely to be reviewed in the upcoming monsoon session of Parliament. Under the proposed new law, the CDA would have the power to prosecute CROs, investigators and pharma companies who violate rules of clinical trials. Those who do so could soon face imprisonment of five years and a fine of Rs 20 lakh (€36,000). "We will not compromise on any clinical trials and research that is being conducted in the country,"​ said Drug Controller General of India (DCGI) M. Venkateshwarulu, who was present at the ACRP inauguration. "We all need drugs with better drug delivery system. There is need for more transparency and knowing about the associated risk factors to encourage more participation from the public." ​ There are an increasing number of clinical trials being run in the country but at the moment there is no regulatory system in place to monitor them, he said. Sitting presently at around 1.5 per cent, within the next 10 to 15 years, 30 per cent of the world's clinical research will be conducted in India, according to Venkateswarlu. If approved these new regulations could provide a safety net for patients and volunteers who participate in clinical trials in India. "The people who undergo clinical trials of drugs should not be exploited. They should be well informed about the risks. Their safety should be ensured."

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