This Office Memorandum, reference number F. No X1102624 2018BD, issued by the Directorate General of Health Services, Office of Drugs Controller General India, Biological Division, FDA Bhawan, Kotla Road, New Delhi 110002, and dated October 7, 2014, outlines a guarantee concerning compliance with the provisions of Drugs & Cosmetics rules 1945. The memorandum stipulates that all vaccines/sera must comply with the aforementioned rules and fulfill the necessary quality requirements according to Indian Pharmacopoeia. Furthermore, it mandates communication of any related actions to the Directorate. The memorandum is addressed to Drugs Controllers General and copied for information to the DGHS, Ministry of Health and Family Welfare, NIB Noida, PS to JS (R), Ministry of Health and Family Welfare, and ADC(I) of Zonal and sub-zonal offices of CDSCO.
Key Entities Referenced
Directorate General of Health Services: An organization, likely a part of the Indian government, responsible for health services.
Drugs Controller General India: A regulatory authority in India responsible for the control of drugs.
Biological Division FDA Bhawan, Kotla Road, New Delhi 110002: A division within the Drugs Controller General India, located at FDA Bhawan in New Delhi.
Drugs Cosmetics: Refers to the Drugs and Cosmetics Act, an Indian law regulating drugs and cosmetics.
Dr. G. N. Singh: The individual who signed the memorandum, potentially the Drugs Controller General.
CDSCO: Central Drugs Standard Control Organisation, an Indian regulatory body for pharmaceuticals and medical devices.
Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi: A ministry of the Government of India responsible for health policy.
NIB Noida: National Institute of Biologicals, an autonomous institution under the Ministry of Health & Family Welfare, Government of India located in Noida, Uttar Pradesh.
F. No X-11026/24
2018-BD
Directorate General of Health Services
Office of Drugs Controller General (India)
(Biological Division)
FDA Bhawan, Kotla Road,
New Delhi 110002
Dated: O7-0 2-14
Office Memorandum
tice Memorandum
letter of guarantee, subjected to the condition that:
1) AT ch te 1p 9r 4o 0d u ac nt d s Rh ua ll el s ,c o 1m 9p 4l 5y tw hi et rh e ua nl dl et rh .e provisions of Drugs & Cosmetics
2) scY a ao s mu e e m t sa h hey a l p lt ra bok ede u ra c e t cw ar lii s lt et d de e n fc rlu oan r md e e tdr
h
t eaa s mk ai n rn o kg t
e
tf o .r fo sm t t ah ne d aI rn dd i qa un a la ig te yn t b ys t ta ht ei n Ng I t Bh ,a t t hi en
The action taken in this regard shall be communicated
to this Directorate.
(Dr. G. N. Singh)
To:- Drugs Controll General (1)
All port offices of CDSCO
Copy for information to:
1. DP eP lS h it -o 1D 1G 0H 00S 1, Ministry of Health and Family Welfare, Nirman Bhawan, New
2. The Director, NIB Noida
3. PS to JS (R), Ministry of Health and Family Welfare, Nirman Bhawan, New
Ol A Ol Pl P ID ,D MC u m(1 b) a/ iADC (I) of Zonal and sub-zonal offices of CDSCO. ws