Drug controller allows Indian firm to conduct phase 1 trials for Zika vaccine
Indian Express
New Delhi: December 19, 2017
Zika is an infection
spread by the Aedes egypti mosquito. Infections in pregnant women can cause
children to be born with brain deficiencies
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.
Comments
Post a Comment