DCGI allows Indian firm to conduct phase 1 trials for Zika vaccine
The Drugs Controller General of India has granted permission to an Indian firm to conduct Phase-I clinical trials for a Zika vaccine. Zika is an infection spread by the Aedes egypti mosquito. Infections in pregnant women can cause children to be born with brain deficiencies. Union Minister of State for Health and Family Welfare Ashwini Kumar Choubey told the Lok Sabha on Monday 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 per cent efficacy in animals for grant of permission to conduct the Phase-I clinical trial. Based on the evaluation of application, in consultation with the Experts Committee, the DCG (I) has granted permission to conduct the Phase-I clinical trial,” he said in a written reply to a question. Phase I trials ascertain the safety, tolerability and physiological action of a compound inside the body.
Anupriya Patel, also Union Minister of State for Health and Family Welfare, said in another written reply that the World Health Organisation (WHO) had declared the Zika virus to be a Public Health Emergency of International Concern on February 1, 2016, following an outbreak in Brazil and other Latin American 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,” Patel 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.