CDSCO ( Central Drug's Standard control Organisation ):

CDSCO (Central Drug's Standard control Organisation) : 

CONTEXT:-

# The Central Drug's Standard Control Organisation (CDSO) has asked commonly-used antibiotics manufacturers to ensure its details be made available to the general public.

# This decision was taken considering directives from the National co-ordination Center of the Pharma-Covigilance Programme of India (PVPI) .

WHAT IS PHARMA-COVIGILANCE PROGRAMME OF INDIA (PVPI):-

# The PVPI was started by the government of India on 14'th July 2010 With the AIMS New Delhi as the National Co-ordination Center for monitoring Adverse Drug Reactions (ADRR) in the country for Safe-guarding Public Health.

# Pharma-Covigilance is  defined as the science relating to the detection , Assessment, Understanding and prevention of adverse effects , principally long term and short term adverse effects of medicines.

# The CDSCO has a Natioo-Wide Pharma-Covigilance Programme for protecting the health of the potients by promising drug safety.

# The program is coordinated by the Indian Pharmacopeia commission Ghaziabad as a National Co-ordinating Centre (NCC) .

ABOUT CDSCO:-

The Central Drug's Standard control Organisation (CDSCO) Under Directorate General of Health Services , Ministry of Health and Family Welfare , Government of India in the National Regulatory Authority (NRA) of INDIA.

FUNCTIONS:-

# Under the Drug's and Cosmetics Act , CDSCO is Responsible for approval of New Drugs , Conduct of Clinical Trials , Laying down the Standards for Drug's Control over the quality of Imported Drugs in the country and Co-ordination of the Activities of the State Drug control Organisation by providing expert advy with a View of bring about the Uniformity in the Inforcement of the Drug's and Cosmetics ACT.

# CDSCO Along with State Regulator's is Jointly Responsible for grant of Licenses of certain specialized Categories of Critical Drug's such as Blood and Blood products , I.V Fluids Vaccine and Sera.