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Date: 2022-02-22 Category: Not Applicable State: Union Government Country: India

Revised Schedule for Public hearing at PRO, CDSCO (HQ)

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This notice from the Central Drugs Standard Control Organisation (CDSCO) announces a revised schedule for public hearings at the Public Relations Office, CDSCO (HQ), New Delhi.
  • These public hearings are intended to provide regulatory guidance to stakeholders and innovators.

Key Changes

  • The notice revises the schedule for public hearings previously announced on October 4, 2019, and December 10, 2021.
  • The revised schedule allocates specific days and time slots for different divisions within CDSCO to conduct public hearings.
  • Monday: Medical Device & IVD (1st Half), CDAC & Blood Bank (2nd Half)
  • Tuesday: New Drugs & SND (1st Half), FDC & GCT (2nd Half)
  • Wednesday: Cosmetics, Veterinary & International Cell (1st Half), Medical Device, IVD & CDAC (2nd Half)
  • Thursday: Import & Registration (1st Half), Biological & LVP (2nd Half)
  • Friday: Ayush & Ethics Committee (1st Half), CDAC & BAIBE (2nd Half)

Impact Analysis

Stakeholders

  • Ethics Committees: Impacted by changes to public hearing schedules related to Ethics Committee matters.

Suggested Action Items

  • Monitor the CDSCO website for any further updates or changes to the public hearing schedule.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. Public Relations Office, CDSCO (HQ): The location where the public hearings are conducted. Medical Device & IVD: Division within CDSCO responsible for Medical Devices and In-Vitro Diagnostics. CDAC: Division within CDSCO. (Full form not specified in the notice) Blood Bank: Division within CDSCO responsible for Blood Bank related matters. New Drugs & SND: Division within CDSCO responsible for New Drugs and Subsequent New Drugs. FDC & GCT: Division within CDSCO responsible for Fixed Dose Combinations and Global Clinical Trials. Cosmetics: Division within CDSCO responsible for Cosmetics. Veterinary: Division within CDSCO responsible for Veterinary drugs. International Cell: Division within CDSCO responsible for International matters. Import & Registration: Division within CDSCO responsible for Import and Registration of drugs. Biological & LVP: Division within CDSCO responsible for Biologicals and Large Volume Parenterals. Ayush: Division within CDSCO responsible for Ayush products. Ethics Committee: Division within CDSCO responsible for Ethics Committee related matters. BAIBE: Division within CDSCO responsible for Bioavailability and Bioequivalence studies. Public Notice dt. 04.10.2019 & 10.12.2021: Previous public notices regarding public hearings by CDSCO.
Official Source Record View Original Source →
See Full Document Text
File No X-11 026/030/19 Ministry of Health and Family Welfare Directorate General of Health Services Central Drugs Standard Control Organisation (HQ) (Public Relations Office) FDA Bhawan, Kotla Road New Delhi-1 10002 Date : '1. ~ f 02..J 2<.12'2. NOTICE In continuation to this Directorates Public Notice of even number dt. 04.10.2019 & 10.12.2021 regarding public hearing by respective division at Public Relations Office CDSCO (HQ), New Delhi is operational in following manner to strengthen the process of regulatory guidance to stakeholders and innovators. The schedule is revised as follows in public interest. ----- Day 15t Half - 2DD Haif Monday Medical Device & IVD CDAC & Blood Bank -- Tuesday New Drugs & SND FDC & GCT Cosmetics, Veterinary Medical Device, IVD Wednesday &CDAC & International Cell Thursday Import & Registration Biological & LVP Friday Ayush & Ethics Committee CDAC & BAIBE All stakeholders may avail the facilities as per their requirement. . y.- ~-.-y (Dr. V G Somani) Drugs Controller General (India) Copy To­ 1. JDC(SER)/JDC(PBN), JDC(APK) 2. All DDC(I)s/ADC(I)s at CDSCO (HQ) 3. IT Cell for uploading on website of CDSCO 4. Guard File

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