CDSCO - GOVERNANCE
News: Central
Drugs Standard Control Organization bars Tamil Nadu-based firm from making eye
lubricant
What's in the news?
● The
Central Drugs Standard Control Organization (CDSCO) has instructed Tamil
Nadu-based Global Pharma Healthcare
to stop manufacturing all the products under the category of ophthalmic
preparation till the completion of an investigation.
● The
move came soon after the U.S. Centers for Disease Control and Prevention (CDC)
linked the company’s eye drops to 55 adverse events in the U.S.
CDSCO:
● CDSCO
comes under the Directorate General of Health Services, Ministry of Health & Family Welfare.
● 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.
● Under
the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs,
Conduct of Clinical Trials.
● 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 Organization (CDSCO) is India’s main regulatory
body for medical devices. The Drug Controller General of India is an important
office within the CDSCO.
● DCGI
is responsible for authorizing the production of medical equipment.
● In
India, the CDSCO is in charge of overseeing the registration and sale of
certified medical equipment.
3. Biology:
● 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.
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.