Questions and Answers
How many Sub Zonal Offices are mentioned?
What is one of the main responsibilities of the Headquarters at CDSCO?
Which city is NOT listed as a Central Drugs Laboratory?
What does the acronym GCT stand for in the context of clinical trials?
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Which of the following is a role of Zonal Offices?
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What is the main focus area of the CDSCO Lab?
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Which office is responsible for import and export processes?
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Which division is NOT represented at the CDSCO Headquarters?
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What does the abbreviation DTAB stand for?
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Which set of regulations was published on March 19, 2019?
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Which of the following achievements relates to drug samples testing?
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Which of the following is NOT a type of vigilance program mentioned?
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What ensures a 24X7 clearance of consignments at ports in India?
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Which organization declared CDSCO as a functional National Regulatory Authority?
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What measure was taken to address the issue of animal testing in cosmetics?
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What was the purpose of establishing a Public Relation Office (PRO) at CDSCO?
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What is one of the major gaps in conducting clinical trials in India?
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Which of the following is NOT a responsibility of CDSCO?
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What role does the DCGI have in trials related to adverse events?
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What issue contributes to the inefficiency of clinical trials in India?
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Which statement about CDSCO is true?
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What regulatory function has recently been added to CDSCO's responsibilities?
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Which of the following is a recent regulatory challenge for CDSCO?
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What is the primary concern regarding drug testing facilities in India?
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What primary law governs the Indian drug regulatory system?
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Which level of government is primarily responsible for drug regulation in India?
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What is one of the primary responsibilities of the State Licensing Authority in India?
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Which of the following is NOT a focus area of CDSCO?
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What do the gaps in regulatory requirements for clinical trials refer to?
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Which organization is responsible for overseeing the drug regulatory framework in India?
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What role does the Central Government play in the drug regulatory system?
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Which ministry is NOT typically involved in the drug regulatory system in India?
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What is the primary role of the State Licensing Authority (SLA)?
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Which of the following ministries is NOT mentioned as involved in the regulatory process for clinical trials?
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Which agency is responsible for the approval of clinical trials in India?
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Which of the following is NOT a responsibility of the central regulatory authorities?
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Which organization evaluates serious adverse events (SAE) during clinical trials?
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Who leads the State Licensing Authority?
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What role does the National Pharmaceutical Pricing Authority (NPPA) play?
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Which committee is associated with the review of genetic manipulation?
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What does the State Licensing Authority monitor?
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Which of the following best describes the role of the Department of Science & Technology (DST)?
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Study Notes
Overview of Indian Drug Regulatory System
- The Indian drug regulatory system operates under the Drugs and Cosmetics Act, 1940, and its rules established in 1945.
- Regulation occurs at both the Central and State levels, with ‘drugs’ categorized under the concurrent list in India’s Constitution.
- CDSCO oversees drug regulation, with various offices including Central Drugs Laboratories and Sub Zonal Offices across the country.
CDSCO Structure and Responsibilities
- CDSCO comprises numerous divisions handling new drugs, biologicals, medical devices, cosmetics, and clinical trials.
- Functions include approving new drugs and medical devices, overseeing clinical trials, and ensuring compliance with Good Manufacturing Practices (GMP).
- Central responsibilities involve import oversight, ethics committee registration, and serious adverse event evaluation.
State Licensing Authority (SLA)
- SLAs in India establish licensing authority under different names, e.g., FDA, DCA.
- Each state has its own authority to regulate drugs and cosmetics, led by a Commissioner or Drug Controlling Authority.
- State responsibilities focus on licensing manufacturing and quality monitoring of drugs.
Involvement of Other Ministries/Departments
- Key ministries involved in drug regulation include:
- Ministry of Chemicals and Fertilizers
- National Pharmaceutical Pricing Authority (NPPA)
- Indian Council of Medical Research (ICMR)
- Department of Biotechnology and Genetic Engineering Appraisal Committee (GEAC)
- These departments collaborate in areas such as pricing regulation and biotechnology oversight.
Achievements of CDSCO
- Prohibited 344 irrational Fixed Dose Combinations (FDCs).
- Introduced e-governance through the SUGAM Portal to streamline processes.
- Established timelines for processing applications to facilitate efficient regulatory actions.
- Initiated a nationwide drug survey, testing around 47,000 drug samples.
- Implemented pharmacovigilance programs, prohibiting animal testing for cosmetics.
Identification of Regulatory Gaps/Challenges
- Manpower shortages in technical and administrative sectors.
- Space constraints at CDSCO locations affecting operational efficiency.
- Inequities in drug testing facilities for chemical, biological, and medical substances.
- Enhanced responsibilities regarding monitoring clinical trials and Ethics Committee registrations.
Summary of Lecture
- Covered CDSCO structure, including hierarchy and functions.
- Discussed roles and responsibilities at both state and central levels.
- Highlighted CDSCO’s achievements and regulatory challenges needing addressing.
Recap of Key Information
- CDSCO is responsible for the approval of new drugs and clinical trials in India.
- CDSCO is headed by the Drugs Controller General of India.
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Description
This quiz covers the essential regulatory requirements for conducting clinical trials in India, focusing on IND/New Drug applications. Learn about the Indian drug regulatory system overseen by CDSCO and SLA, along with the key legal and procedural aspects involved. Perfect for students and professionals needing to update their knowledge in this area.
