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India has begun to bounce back in clinical trials with the new regulations issued at frequent intervals. This has enabled global pharma and clinical research organisations (CROs) to re-consider conduct of human studies in the country, said Naz Haji, SVP and head of India, Indonesia, Malaysia and Singapore operations, Quintiles.
“This change in regulations specific to clinical trials is progressive for both Indian companies and its patient population. Big pharma has evinced interest and is comfortable to kick start human studies once again in India which was considered a promising hub until end of 2012,” he added.
“However, the government along with the industry will need to reinstate efforts to ensure that the regulatory enforcement system in the country is able to step up the pace of approvals and provide the required clearances in a time bound manner. Clinical trials are important in patient care and therefore we are educating our customers internally that human studies are expected to surge supported by adequate assistance from the Indian regulators,” Haji told Pharmabiz at the sidelines of the DIA Life Sciences IT-enabled business conference held here in Bengaluru.
“Our strategy from a company perspective is to capture new opportunities driven by the government’s regulations and create a patient awareness to opt for clinical trials for their medical needs. So long the global companies whose trials constituted a substantial chunk of India’s clinical research business were unsure of India. The lack of regulations and uncertainty on the required approvals were looming large. But now we are convincing them that the environment is conducive and appropriate for clinical trials”, stated Haji adding that all Indian clinical research companies would need to move on similar lines to convince both multinational majors and the Indian patient population.
As it stands, regulations in India are adequate to ensure traction in clinical trials. There is enough momentum in the last nine months to ensure the prevalence of a comfort zone. Now with the latest guidance issued the Union health ministry early this month permitting clinical trials at hospitals with less than 50 beds and with no restriction on the number of clinical trials an investigator could take up at a time in the country, are expected to give a big impetus to growth, he said.
India is much-sought-after by international drug majors and CROs for human studies. The big benefits in this country are the combination of qualified doctors and patient pool along with the hospital infrastructure. Now with implementation of ICT (information and communication technology), the infrastructure needs are evolving with wireless networks, mobiles, higher-quality video viewing and broader bandwidth connections. For Quintiles too, India is key in its future game plan as we continue to invest in both individuals and infrastructure to serve companies here, said Haji.
Furthermore, global pharma and CROs too are beginning trust the reliability on the Indian regulatory system. Another positive for India is that the government itself is reaching out facilitate partnerships and collaborations. “Therefore, this country is bouncing back as it has emerged out of the dark phase of decline in human studies. We foresee 2017 to be more positive as sponsors making a big comeback,” he noted.
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