Podcast
Questions and Answers
What is the role of the Central Drugs Standard Control Organization (CDSCO)?
What is the role of the Central Drugs Standard Control Organization (CDSCO)?
Which of the following is NOT one of the responsibilities of CDSCO?
Which of the following is NOT one of the responsibilities of CDSCO?
The Indian drug regulatory system is governed by the Drugs and Cosmetics Act, 1940.
The Indian drug regulatory system is governed by the Drugs and Cosmetics Act, 1940.
True
What does NRA stand for in the context of CDSCO?
What does NRA stand for in the context of CDSCO?
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The CDSCO headquarters is situated at ____.
The CDSCO headquarters is situated at ____.
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Match the following CDSCO offices with their locations:
Match the following CDSCO offices with their locations:
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Study Notes
Overview of Indian Drug Regulatory System
- Regulates drugs, cosmetics, and medical devices via the Drugs and Cosmetics Act, 1940, and associated rules from 1945.
- Functions at both central and state levels, with health-related drug regulation under the concurrent list in the Indian Constitution.
Central Regulatory Authority
- Central Drugs Standard Control Organization (CDSCO) operates under the Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare (MoH&FW).
- The CDSCO is considered the National Regulatory Authority (NRA) of India, overseen by the Drugs Controller General of India (DCG(I)).
- Headquarters located at FDA Bhawan, Kotla Road, New Delhi.
Responsibilities of CDSCO
- Approves clinical trials, new drugs, medical devices, biopharmaceuticals, vaccines, biosimilars, and stem cell products.
- Monitors clinical trials through thirteen zonal and sub-zonal offices across India.
CDSCO Offices and Laboratories
- Six zonal offices located in Ghaziabad, Mumbai, Chennai, Kolkata, Ahmedabad, and Hyderabad.
- Seven sub-zonal offices in Chandigarh, Bangalore, Goa, Jammu, Guwahati, Indore, and Varanasi.
- Eight central drug laboratories situated in Kolkata, Mumbai, Chennai, Hyderabad, Chandigarh, Guwahati, Kasuali, and NIB Noida.
- Thirteen port offices manage import and export regulations.
Various Divisions at CDSCO
- Divided into several specialized divisions at headquarters focusing on:
- New Drugs
- Biologicals
- Medical Devices & IVD (In Vitro Diagnostics)
- Cosmetics
- Specific processes include:
- Investigational New Drug (IND) applications
- New Biologicals
- Clinical Investigations (CI) for medical devices
- Registration processes for cosmetics and new drugs.
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Description
Explore the structure and functions of the Indian Drug Regulatory System, including the Central Drugs Standard Control Organization (CDSCO) and its responsibilities. This quiz provides insights into how drugs, cosmetics, and medical devices are regulated in India under the Drugs and Cosmetics Act of 1940.
