DCGI allows Indian firm to conduct phase 1 trials for Zika vaccine
The Drugs Controller General of India (DCGI) has granted permission to Indian firm to conduct Phase-I clinical trials for a Zika vaccine. It was announced by Union Minister of State (MoS) for Health and Family Welfare Ashwini Kumar Choubey in Lok Sabha.
Zika Virus is vector borne diseases spread by Aedes egypti mosquito. Infections in pregnant women can cause children to be born with brain deficiencies (microcephaly) and Guillain-Barré syndrome (GBS). Microcephaly is condition where a baby’s head is much smaller than expected.
The World Health Organisation (WHO) had declared Zika virus as Public Health Emergency of International Concern in February 2016, following an outbreak in Brazil and other Latin American countries and its association with birth defects in newborns. It was revoked in November 2016
The Indian firm had submitted an application along with non-clinical (animal) toxicity data, claiming 100% efficacy in animals to the DCGI to conduct Phase-I clinical trials of its Zika vaccine. Based on evaluation of application, in consultation with the Experts Committee, the DCG (I) has granted permission to conduct the Phase-I clinical trial. The Phase I trials ascertain safety, tolerability and physiological action of a compound inside the body.
Drugs Controller General of India (DCGI)
DCGI under gamut of Central Drugs Standard Control Organization (CDSCO) is responsible for approval of licenses of specified categories of drugs such as blood and blood products, vaccines, IV fluids and sera in India.
DCGI lays down standards and quality of manufacturing, selling, import and distribution of drugs in India. It acts as appellate authority in case of any dispute regarding quality of drugs. It prepares and maintains national reference standard. It brings about uniformity in enforcement of Drugs and Cosmetics Act. It trains Drug Analysts deputed by State Drug Control Laboratories and other Institutions.