CDSCO
– SCI & TECH
News: CDSCO Deputy Drugs Controller in
WHO’s expert panel on Biological Standardisation
What's
in the news?
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A. Ramkishan, hailing from Warangal
district, will contribute his expertise as a member of the Expert Advisory
Panel (EAP) on Biological Standardization for the World Health Organization
(WHO) for a period of four years.
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This is the first instance of a person
from India’s regulatory sector gaining a seat on the WHO’s expert panel.
CDSCO:
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CDSCO comes under the Directorate General
of Health Services, Ministry of Health
& Family Welfare.
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It is the National Regulatory Authority
(NRA) of India for Drugs, located in New Delhi and also has six zonal offices,
four sub zonal offices, thirteen Port offices and seven laboratories spread
across the country
●
The
Drugs & Cosmetics Act, 1940 and Rules 1945
have entrusted various responsibilities to central & state regulators for
regulation of drugs & cosmetics.
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Under the Drugs and Cosmetics Act, CDSCO
is responsible for approval of Drugs, Conduct of Clinical Trials.
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Further CDSCO along with state regulators,
is jointly responsible for grant of
licenses of certain specialized categories of critical Drugs such as blood and
blood products, I. V. Fluids, Vaccines etc.
Major
Functions of CDSCO:
1.
Drugs:
●
CDSCO is India’s National Regulatory
Authority (NRA) under the Director-General of Health Services, Department of
Health and Family Welfare; the Government of India is establishing India to
monitor the safety, efficacy, and quality of drugs.
●
CDSCO is responsible for approving New
Drugs, Clinical Trials, setting drug standards, regulating imported drugs,
coordinating the activities of the State Drug Control Agency by providing
expert advice, and at the same time enforcing the Drugs and Cosmetics Act.
2.
Medical Equipment:
●
The Central Drug Standards Control
Organisation (CDSCO) is India’s main regulatory body for medical devices. The
Drug Controller General of India is an important office within the CDSCO.
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DCGI is responsible for authorising the
production of medical equipment.
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In India, the CDSCO is in charge of
overseeing the registration and sale of certified medical equipment.
3.
Biology:
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Biological products, or biologicals, are
medical products. Many biologics are made from various natural resources
(human, animal or microorganisms). Like drugs, some organisms are intended to
treat, prevent or diagnose diseases and medical conditions. Biological products
include:
○
Vaccines.
○
Blood and Blood products for transfusion
and production of other products.
○
Antimicrobials are used for diagnosis and
treatment (for example, Allergies).
○
Human cells and tissues for
transplantation (e.g., muscles., Muscles and bones).
○
Genetics and cellular therapy.
○
Screening tests that may donate blood for
infectious substances like HIV.
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CDSCO is responsible for providing the NOC
with issuing Form 29 (drug production for testing purposes, rDNA products, Stem
cells and Cell-based products, Blood & Blood Products, animal vaccines)
authorization.