Current Regulatory Requirements for Clinical Trials in India
42 Questions
6 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

How many Sub Zonal Offices are mentioned?

  • Eight
  • Six
  • Thirteen
  • Seven (correct)

    • What is one of the main responsibilities of the Headquarters at CDSCO?

  • Testing of drugs
  • Conduct GMP audits
  • Pharmacovigilance (correct)
  • Import registration

    • Which city is NOT listed as a Central Drugs Laboratory?

  • Hyderabad
  • Kolkata
  • Goa (correct)
  • Chennai

    • What does the acronym GCT stand for in the context of clinical trials?

    <p>Global Clinical Trial</p> Signup and view all the answers

    Which of the following is a role of Zonal Offices?

    <p>GMP audits</p> Signup and view all the answers

    What is the main focus area of the CDSCO Lab?

    <p>Testing and validation of drugs</p> Signup and view all the answers

    Which office is responsible for import and export processes?

    <p>Port Office</p> Signup and view all the answers

    Which division is NOT represented at the CDSCO Headquarters?

    <p>Food Products</p> Signup and view all the answers

    What does the abbreviation DTAB stand for?

    <p>Drugs Technical Advisory Board</p> Signup and view all the answers

    Which set of regulations was published on March 19, 2019?

    <p>New Drug &amp; Clinical Trial Rules</p> Signup and view all the answers

    Which of the following achievements relates to drug samples testing?

    <p>47000 drug samples tested in government labs.</p> Signup and view all the answers

    Which of the following is NOT a type of vigilance program mentioned?

    <p>Envirovigilance</p> Signup and view all the answers

    What ensures a 24X7 clearance of consignments at ports in India?

    <p>CDSCO regulations</p> Signup and view all the answers

    Which organization declared CDSCO as a functional National Regulatory Authority?

    <p>WHO</p> Signup and view all the answers

    What measure was taken to address the issue of animal testing in cosmetics?

    <p>Testing of cosmetics on animals was prohibited.</p> Signup and view all the answers

    What was the purpose of establishing a Public Relation Office (PRO) at CDSCO?

    <p>For grievance redressal</p> Signup and view all the answers

    What is one of the major gaps in conducting clinical trials in India?

    <p>Shortage of manpower</p> Signup and view all the answers

    Which of the following is NOT a responsibility of CDSCO?

    <p>Conducting clinical trials</p> Signup and view all the answers

    What role does the DCGI have in trials related to adverse events?

    <p>Causality assessment and compensation decisions</p> Signup and view all the answers

    What issue contributes to the inefficiency of clinical trials in India?

    <p>Space constraints for laboratories</p> Signup and view all the answers

    Which statement about CDSCO is true?

    <p>It has a zonal and sub-zonal office structure.</p> Signup and view all the answers

    What regulatory function has recently been added to CDSCO's responsibilities?

    <p>Complete monitoring of clinical trials including site inspections</p> Signup and view all the answers

    Which of the following is a recent regulatory challenge for CDSCO?

    <p>Complete registration of all Ethics Committees in India</p> Signup and view all the answers

    What is the primary concern regarding drug testing facilities in India?

    <p>They lack adequate testing capabilities.</p> Signup and view all the answers

    What primary law governs the Indian drug regulatory system?

    <p>Drugs and Cosmetics Act, 1940</p> Signup and view all the answers

    Which level of government is primarily responsible for drug regulation in India?

    <p>Both Central and State Government</p> Signup and view all the answers

    What is one of the primary responsibilities of the State Licensing Authority in India?

    <p>Granting licenses for local drug manufacturing</p> Signup and view all the answers

    Which of the following is NOT a focus area of CDSCO?

    <p>Controlling pharmaceutical advertising</p> Signup and view all the answers

    What do the gaps in regulatory requirements for clinical trials refer to?

    <p>Incomplete ethical guidelines for trials</p> Signup and view all the answers

    Which organization is responsible for overseeing the drug regulatory framework in India?

    <p>Central Drugs Standard Control Organization (CDSCO)</p> Signup and view all the answers

    What role does the Central Government play in the drug regulatory system?

    <p>Setting fundamental regulatory frameworks and guidelines</p> Signup and view all the answers

    Which ministry is NOT typically involved in the drug regulatory system in India?

    <p>Ministry of Information Technology</p> Signup and view all the answers

    What is the primary role of the State Licensing Authority (SLA)?

    <p>To regulate drug manufacturing and sales in the state</p> Signup and view all the answers

    Which of the following ministries is NOT mentioned as involved in the regulatory process for clinical trials?

    <p>Ministry of Agriculture</p> Signup and view all the answers

    Which agency is responsible for the approval of clinical trials in India?

    <p>Central Drugs Standard Control Organisation (CDSCO)</p> Signup and view all the answers

    Which of the following is NOT a responsibility of the central regulatory authorities?

    <p>Monitoring quality of drugs</p> Signup and view all the answers

    Which organization evaluates serious adverse events (SAE) during clinical trials?

    <p>Central Drugs Standard Control Organisation (CDSCO)</p> Signup and view all the answers

    Who leads the State Licensing Authority?

    <p>Commissioner or Drug Controlling Authority</p> Signup and view all the answers

    What role does the National Pharmaceutical Pricing Authority (NPPA) play?

    <p>Regulating pricing of pharmaceuticals</p> Signup and view all the answers

    Which committee is associated with the review of genetic manipulation?

    <p>Review Committee on Genetic Manipulation (RCGM)</p> Signup and view all the answers

    What does the State Licensing Authority monitor?

    <p>Quality of drugs and cosmetics</p> Signup and view all the answers

    Which of the following best describes the role of the Department of Science & Technology (DST)?

    <p>Supporting biotechnology initiatives</p> Signup and view all the answers

    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.

    Studying That Suits You

    Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

    Quiz Team

    Related Documents

    Current Regulatory Requirements for Conducting Clinical Trials in India for IND/New Drug PDF

    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.

    More Like This

    Use Quizgecko on...
    Browser
    Open
    Browser
    Browser