**Policy Summary: Abeyance of Notice Regarding Rabies Vaccine Availability**
This notice, issued by the Drugs Controller General of India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, announces the abeyance of Notice No. X110261615BD, dated 27.05.2016, concerning rabies vaccine. The decision to keep the aforementioned notice in abeyance was made in the larger public interest, with the intention of ensuring the continued availability of the vaccine to the general public. This action follows a representation made by Ms. Indian Immunologicals Limited, Hyderabad, to the Secretary of the Ministry of Health and Family Welfare, and subsequent discussions with the Directorate General of Health Services (DGHS) and the Additional Secretary, Food and Drug (FD). The notice is addressed to all States and Union Territories Drugs Controllers, as well as all manufacturers and importers of rabies vaccine. Copies are 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 issuing authority is Dr. N. Singh, Drugs Controller General of India.
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 in the Government of India responsible for health policy.
Indian Immunologicals Limited, Hyderabad, Telangana: An Indian vaccine manufacturer located in Hyderabad, Telangana, that made a representation regarding the notification.
Rabies Vaccine: A vaccine used to prevent rabies infection.
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare, Government of India.
National Centre for Disease Control, New Delhi: An institute under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, responsible for disease control.
New Delhi, Delhi: The location of several organizations mentioned in the document including the Directorate General of Health Services and the National Centre for Disease Control.
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