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Indian firm gets drug controller nod for phase-I clinical trial of Zika vaccine

Indian firm gets drug controller nod for phase-I clinical trial of Zika vaccine

New Delhi: The Drugs Controller General (India) has granted permission to an Indian firm to conduct Phase-I clinical trial, in pursuance to its application to the DCG (I) on a Zika virus vaccine, the government has said.

Union Minister of State for Health and Family Welfare Ashwini Kumar Choubey in the Lok Sabha had said that an Indian firm had submitted an application to the drugs controller.

“The application was on the Zika virus vaccine, along with non-clinical (Animal) Toxicity data, claiming 100 percent efficacy in animals for grant of permission to conduct the Phase-I clinical trial,” he said in a written reply to a question.

“Based on the evaluation of the application, in consultation with the Experts Committee, the DCG (I) has granted permission to conduct the Phase-I clinical trial,” Choubey said.

On the same day, Anupriya Patel, also Union Minister of State for Health and Family Welfare, said in a written reply that the World Health Organisation (WHO) had declared the Zika virus disease to be a Public Health Emergency of International Concern (PHEIC) on February 1, 2016, following the Zika outbreak in Brazil and other Latin countries and its association with birth defects (microcephaly) in newborns.

“Further, the WHO declared that it ceased to be a Public Health Emergency on November 18, 2016,” she said.

She added that the ministry has a three-pronged action plan on combating the disease, and there are 27 laboratories in the government sector that can test the Zika virus disease.

Source: PTI
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