Home India Ministry of Health and Family Welfare Presentation for Rabies Vaccine- regarding...
Date: 2016-09-08 Category: Not Applicable State: Union Government Country: India

Presentation for Rabies Vaccine- regarding

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

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Executive Summary & Key Takeaways

**Policy Summary:** This notice, issued by the Drugs Controller General of India, Central Drugs Standard Control Organization on September 6, 2016, pertains to the availability of rabies vaccine. The notice announces that Notice no. X110261615BD dated 27.05.2016 is being held in abeyance. This decision follows a representation made by Indian Immunologicals Limited, Hyderabad, to the Secretary, Ministry of Health and Family Welfare, Government of India, and subsequent discussions with the Directorate General of Health Services (DGHS) and Additional Secretary FD, Ministry of Health and Family Welfare. The original notice is being held in abeyance in the larger public interest to ensure the rabies vaccine remains accessible to the general public. The notice is addressed to all States and Union Territories Drugs Controllers and all manufacturers and importers of rabies vaccine. Copies have been circulated to the PPS to DGHS, MoHFW, New Delhi; PPS to AS FD, MoHFW, New Delhi; the Director, National Centre for Disease Control, MoHFW, New Delhi; and all zonal, sub-zonal, and port offices of CDSCO. The contact person for this notice is Dr. N. Singh, Drugs Controller General I. The document's reference number is F. No. X110261615BD.

Key Entities Referenced

Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India. Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) in India. Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy. Rabies Vaccine: A vaccine used to prevent rabies. Indian Immunologicals Limited, Hyderabad, Telangana: An Indian vaccine manufacturer located in Hyderabad, Telangana. Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare, Government of India. Dr. N. Singh: The Drugs Controller General of India. National Centre for Disease Control, New Delhi: An institute under the Directorate General of Health Services, Ministry of Health and Family Welfare in New Delhi.
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F. No. X-11026/16/15-BD Directorate General of Health Services Central Drugs Standard Control Organization Office of Drugs Controller General India (Biological Division) FDA Bhawan, Kotla Road, New Delhi — 110002, India Dated: Notice 68 SEP 0K Subject: Presentation for Rabies Vaccine - Regarding. This is in reference to the Notice no. X-11026/16/15-BD dated 27.05.2016 issued by this Directorate. A representation was made to the Secretary, Ministry of Health and Family Welfare, Government of India by M/s Indian Immunologicals Limited, Hyderabad on the above notification. After discussing the issue with DGHS and Additional Secretary (F&D), Ministry of Health and Family Welfare, the above mentioned notice is kept in abeyance in larger public interest so as to make the vaccine available to the general public. (Dr. -N. Singh) Drugs Controll General (I) To: 1. All States and UT’s Drugs Controller 2. All manufacturers and importers of rabies vaccine Ce: 1. PPS to DGHS, MoH&FW, New Delhi 2. PPS to AS (F&D), MoH&FW, New Delhi 3. Director, National Centre for Disease Control, MoH&FW, New Delhi 4, All zonal, sub-zonal and port offices of CDSCO

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