**Subject: Regulation of Manufacturing and Marketing of Unapproved Drug, Vitamin K27**
This communication from the Drugs Controller General India, dated January 1, 2016, addresses all State Licensing Authorities regarding the manufacturing and marketing of the unapproved drug, Vitamin K27. The communication references a previous observation regarding the marketing of Vitamin K27 products and emphasizes that the drug remains unapproved.
Specifically, the communication refers to an investigation of M/s. Kataria Healthcare Private Limited, situated at Khewat No. 475/428, Kh. No. 477, Village Nandauli, Tehsil Baddi, District Solan-173205 (H.P.) regarding this issue. This firm was found to be marketing the product in violation of existing regulations. The referenced DC File No. K04/270/2015/Lic. and Enquiry No. K04/06/2015 is associated with this case.
The State Licensing Authorities are directed to take necessary action based on this information.
The communication is signed by Dr. G. N. Singh, Drugs Controller General India, and copies have been distributed to all Zonal and Sub-Zonal offices of the Central Drugs Standard Control Organisation (CDSCO).
Key Entities Referenced
CDSCO: Central Drugs Standard Control Organization
Directorate General of Health Services: An organization under Ministry of Health and Family Welfare, Government of India. The notification is issued by this directorate.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) in India, responsible for regulating pharmaceuticals and medical devices.
FDC Division: Functional division within the Office of Drugs Controller General India.
FDA Bhawan, Kotla Road New Delhi: Location of the Office of Drugs Controller General India
State Licensing Authorities: The regulatory bodies at the state level in India responsible for granting licenses for manufacturing and marketing drugs.
Vitamin K27: An unapproved drug whose manufacturing and marketing is the subject of the notification.
Dr. G. N. Singh: The Drugs Controller General of India who signed the notification.
File No. 4-01/2015-DC (Misc. 63)
Directorate General of Health Services
Office of Drugs Controller General (India)
FDC Division
FDA Bhawan, Kotla Road
New Delhi-110002
Dated: ,
Q) 1 JAN 206
To,
All State Licensing Authorities,
Subject: RM ea gn au rf da ic nt gu .ring and Marketing of Unapproved Drug, Vitamink2-7-
Sir,
mim na afn you rf bma eecP dtl i ue t nr ha fi as on te r g V m i ere a t df a ne m tdr hi ant tm o Ka b2rt ak -h si e 7s et i di so n f ng of oi nc t e o
t
af
h
p{ ee pu t rt n re oa er vp cen p odo r m. o
m
fv eo1 re
n
2 d dm- a a5 r td0 k ir/ eu o1 tg n2 , i s- n D gV oC fi i t nd
E
a ta xm ht pi ee en d
r
c: to K u0 C2 n4 - t or. 7 my0 .6 mw . iIh2 ne
t
0 tr1 the5 i
e
sb eyr re ,eg gia t a r rd dw ,i a n s ig t
abh fua ois rk e a d sarp iup dgr o l( ev A te P td e! r ) v dca ar a ti eno d u :bs e 0 4f c .o or 0nm 6su .il 2da 0et 1ri 5eo n d is sa ssc u o edn dt e a bei ymn i e tn hdg i s tV ooi f ft b ia e cm ei an mp apK r y2 o - bv7 ee. d d T efh aoe lrr t e t af h co e cr oe p r, u d r iV p ni got lsa yet .mh ii as n n do Kf 2f ti - hc e7e
This is for information and necessary action.
"| faithfully,
he
(Dr. G. N. Singh)
Drugs Controller G&heral (India)
Copy to:
All zonal, Sub Zonal offices of CDSCO