Govt to unveil new rules for drugs, clinical trials soon: official

The Indian government is expected to roll out a new drug policy and devise rules for clinical trials that may bring new projects to the country, says G.N. Singh of DCGI


G.N. Singh said the government has devised new rules that will require more information of the patients enrolling themselves for clinical trials. Photo: Mint
G.N. Singh said the government has devised new rules that will require more information of the patients enrolling themselves for clinical trials. Photo: Mint

Washington: 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 have 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, 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 practises and avoid duplication, Singh told the leaders from pharma industry and research companies.

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