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Date: 2017-02-15 Category: Not Applicable State: Union Government Country: India

Notice regarding Human Vaccines dated 15.02.2017

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 order, issued by the Drugs Controller General (India), mandates that all manufacturers and importers of human vaccines must submit samples from each batch, along with manufacturing and testing protocols, to the Central Drugs Laboratory (CDL), Kasauli, Himachal Pradesh for lot release. This practice continues previous communications and practices.
  • The Director of CDL Kasauli is directed to undertake the lot release process.

Key Changes

  • All manufacturers and importers of human vaccines are required to send samples of each batch to CDL Kasauli for lot release.
  • This order formalizes and continues the existing practice of lot release at CDL Kasauli.
  • CDL Kasauli is officially designated as the laboratory responsible for lot release of human vaccines.

Impact Analysis

Manufacturers and Importers of Human Vaccines

  • Action Items: Review current manufacturing and testing processes to ensure compliance with submission requirements. Establish a system for efficient sample submission and tracking. Factor in potential delays in release timelines.

Central Drugs Laboratory (CDL), Kasauli

  • Action Items: Ensure sufficient capacity and resources to handle the increased workload. Streamline the lot release process to minimize delays. Maintain clear communication with manufacturers and importers regarding submission requirements and timelines.

Central Drugs Standard Control Organization (CDSCO)

  • Action Items: Monitor the effectiveness of the lot release program. Provide support and guidance to CDL Kasauli as needed. Evaluate the need for additional resources or infrastructure to support the program.

State Drugs Controllers, Zonal, Sub Zonal & Port Offices of CDSCO

  • Action Items: Communicate the requirements of the order to all relevant stakeholders. Monitor compliance and report any issues to CDSCO.

Key Entities Referenced

Directorate General of Health Services: Parent organization of the Central Drugs Standard Control Organization (CDSCO). Central Drugs Standard Control Organization (CDSCO): National regulatory body for pharmaceuticals and medical devices in India. Drugs Controller General (India): Head of the CDSCO, responsible for drug regulation and control in India. Central Drugs Laboratory (CDL), Kasauli: National laboratory responsible for testing and quality control of drugs and vaccines. All Manufactures & Importers of Human Vaccine: Entities involved in the manufacturing and import of human vaccines in India. All States Drugs Controller, Zonal, Sub Zonal & Port Offices of CDSCO: Regional offices of CDSCO responsible for enforcing drug regulations.
Official Source Record View Original Source →
See Full Document Text
File No. XII026/11/2017-BD Directorate General of Health Services Central Drugs Standard Control Organization' (0/0 Drugs Controller General India) FDA Bhawan, Kotla Road New Delhi-II 0002 15 FEB 2017 Dated: - ORDER In continuation to earlier communications & practices in this regard, all the manufactures & importers of human vaccines ,,~re required to send thesarnples along with protocol of manufacturing & testing of each batch to Central Drugs Laboratory (CDL), Kasauli, Himachal Pradesh for the purpose of lot release till further orders.i as a functionunder technical control of the undgrsigned. Further, Director, 'Central Drugs Laboratory (CDL), Kasauli, Himachal Pradesh is requested to undertake such lot release. ,(Dr. . N. Singh) Drugs Controller General (India) To" 1. Director, Central Drugs Laboratory (CDL), Kasauli, Himachal Pradesh. 2.t All Manufactures & Importers ofHuman Vaccine 3. All States Drugs Controller, Zonal, Sub Zonal & Port Offices of CDSCO

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