India to roll out new drug policy, devise rules for clinical trials, say officials
Indian government is working with stakeholders to devise new rules for clinical trials that are expected to bring new projects to India.
India is expected to roll out a new drug policy and devise rules for clinical trials that may bring new projects to the country, a top Indian official has said.
A team of Indian officials led by G N Singh, Drug Controller General of India, said a set of new procedures to facilitate clinical trials are expected to be unveiled shortly.
Addressing the annual US-India BioPharma and Healthcare Summit in Boston on Thursday, Singh said the Indian government is working with stakeholders to devise new rules for clinical trials that are expected to bring new projects to India.
Over the last few years, clinical trials in India slowed down amid tedious court litigation and rising protests from health activists on issues related to informed consent and compensation norms, an official statement said.
The government, in consultation with stakeholders, has devised new rules that will require more information of the patients enrolling themselves for clinical trials, Singh said at the day-long conference organised by the 'USA-India Chamber of Commerce'.
In his remarks, Singh talked of efforts to integrate scattered laboratories that can help avoid duplication of research and accelerate the process of drug development.
The government is keen to work on three broad categories: harmonise standards, convergence of regulatory practices and avoid duplication, Singh told the leaders from pharma industry and research companies.
This year prominent attendees included Elias Zerhouni, global R&D head at Sanofi, Andrew Plump, chief medical and scientific officer, Takeda Pharmaceuticals, William Chin, executive VP and chief medical officer, PhRMA, William Hait, global head, R&D, Janssen Pharmaceutical, James Bradner, president, Novartis Institute of Biomedical Research, David Nicholson, chief R&D officer, Allergan and Martin Mackay, executive VP and global head of R&D, Alexion Pharmaceuticals.
In his address, R K Vats, additional secretary, Union Health Ministry, underlined the government's commitment to make business easier for the industry.
He also asserted on the need to have affordable drugs for the Indian patients given that most of the healthcare expenses in the country is paid by the patients, unlike reimbursement models followed in developed markets like the US.
Leaders participating in the summit represent over $45 billion of the R&D budget. This represents over 70 per cent of the global R&D spent in the private sector, said Karun Rishi president of the USA-India Chamber of Commerce.
"This is huge. This group of committed and passionate people are a source of hope for the patients. India has a great, yet unrealised potential to play an important role in the bio pharma research and development," Rishi said.
During the meeting, speakers participated in engaging discussions that ranged from the latest trends in drug discovery to development of rare and neglected diseases and how those could be made accessible in resource-starved settings.
Discussions also focused on developing of vaccines to be prepared for unforeseen medical emergencies such as the outbreak of Zika and Ebola viruses that can potentially cause devastating consequences and kill thousands of people.
Most speakers agreed that given the longer timelines required to develop vaccines, there is a general lack of sustained attention for vaccines research, the statement said.
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