**Summary:**
This order, issued by the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare on July 3, 2014, establishes a cell to coordinate with institutions like the Indian Council of Medical Research (ICMR). The primary objective of this cell is to facilitate and sponsor studies related to drugs and cosmetics. This initiative aims to generate data that will inform decision-making processes related to regulatory approvals and policy formulation within the Ministry of Health and Family Welfare.
The cell will be responsible for identifying areas where studies are needed, coordinating with relevant research institutions, and overseeing the execution of sponsored studies. It will also aim to eliminate redundant efforts to promote focused research to help in decision making.
The cell comprises the following members:
1. Dr. A. Ramkishan, Deputy Drugs Controller India, CDSCO H.Q
2. Shri Somnath Basu, Assistant Drugs Controller India, CDSCO, H.Q
3. Shri M. Balakumar, Drugs Inspector, CDSCO H.Q
These members will coordinate with agencies such as ICMR to utilize funds effectively, avoid duplication of effort, and ensure that studies are conducted to generate useful data for regulatory purposes, particularly concerning drugs and cosmetics.
The order was issued by Dr. G. N. Singh, Drugs Controller General of India, and is addressed to all officers concerned, including JDC I, DDC I, H.Q, and Zonal officers. A copy has also been sent to US D, MOHFW, Nirman Bhawan, New Delhi.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices under the Ministry of Health and Family Welfare in India.
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare, India.
Ministry of Health Family Welfare: The Indian government ministry responsible for public health.
ICMR: Indian Council of Medical Research, the apex body in India for the formulation, coordination and promotion of biomedical research.
New Delhi: The capital of India, where FDA Bhawan and Nirman Bhawan are located.
CDSCO H.Q: Headquarters of the Central Drugs Standard Control Organization.
Dr. A. Ramkishan: Deputy Drugs Controller India, CDSCO H.Q, a member of the cell.
Drugs Controller General India: A key position within the Central Drugs Standard Control Organization responsible for drug regulation in India; Dr. . N. Singh is the current controller.
File No. 12-01/14-DC Pt.47
Central Drugs Standard Control Organization
_ Directorate General of Health Services
Ministry of Health & Family Welfare
FDA Bhawan, Kotla Road, New Delhi-110002
Date: 03.07.2014
ORDER
SUBJECT: Creation of cell for co-ordination with institutes like ICMR for sponsoring
various studies- regarding
S_ tat
u
aph
b
kpe
mr
e
io
nC
v t
h
a t
oa lT
e
n.ih
d
r te m
o hi f
ta eM
s
n i rrnn s eei eh
p
cs i
w
ot op rr
mtd
y
m
o
r
to ef
u
of
n
g
PH
t
dsre
h
a,oa
e
tf l . iMct oilh R
ni
n
a
n i
s& in
s
.cj taF i orla t
y
f
m otR ti
r f
hl o
i
eay Hy
l
esW
Ea
Ce xlahl ptnf ea ha rdu r
t&
d e h
b CF
auh
a
onra mnyd
i mi
lc
n
mt yo o
g
n
i
W
s f
e
tot o lfi r
f
t
t m au du
r
et rl ee
u
ea .d gt
s
Tea
.
hn p
e
E o
T
x l ahip cece ty r
i
ot Ea
nx
nC spdo
e p
m
r
rgm
t
ou i i pCt d oot e smle ei me dn
i
eu
t
tsn
ot
d f bee o eer r -
‘Health & Family Welfare. were finalized by the Ministry of
Cam eda nvr tk e re r at s li e n A Ddgs rr u uS gu gp r se rvr ee a Sit c tl th al ie na o n dncr
a
e e m rp o do o nr f it
C
t, d
o
or nrt u tih g rne s og ,
l
C etr OD ca r.tS gi I aoC t nn wO a iil l
z
l
a
um b ts ia ee
o
y u
n
so efn (f e Cume le Dd d Sii f
C
ci Oai n r )nf ee .o ssr em , Taa hrt d ii cr so hu n g u
u
n nc iu io tt ti n ilt s wi i z ocn a urtu leio o a du n t s el s idy nt
i
u w tdo i ii atn te h es i np
a
o a ts nn ht dd e-
mS ap ko in ns go .r studies in these areas to be able to get the needed information to help in decision-
Ico Cn Mst Ri t fu ot rP e u tdr
h
s ein u ca C on nDt
d
S ut C co
t
O t
o
h fce o
v
m aa p rc r it i oi s uo i sn n s sg
t
ui fn do il et l sh o .i w s i nr g e og fa fr icd i ala ss tod e cc oi -od
.
re dd i nb ay te t wh ie t h M ain gi es nt cry i, e sa s uc cel hl ai ss
1). Dr. A. Ramkishan , Deputy Drugs Controllers (India), CDSCO H.Q
2) Shri Somnath Basu, Asstt, Drugs Controller (India), CDSCO, H.Q
3) Shri. M. Balakumar, Drugs Inspector, CDSCO H.Q
The members of the cell will co-ordinate with agencies such as ICMR, for the
aemc cneo tadn ii bd oc lu ni ec sn t Ce
o
s no D,f
S
c
s oD Cp nre
O
tc u
i
i g
f
nf
o
ui ruc
e
t dcis olt ui nu z std a eiti nie so us n
ue
cf ds ho t er u
v
ddt
a
rih
t
uee
u
gs a, sP
t
o
i
iAs
o
n
dt
n
t- v hom e efa r r
d
csk oree
uu
t ngd ti sr rn yug
m
.g as ru r kr e ev a te cti eil dol ra itn
n
c Ime no dno iif at d o ar r nu i dg ns g t,
o
eR tta act .
k
i eo t n rha eal gt
u
u lw as o te u
o
l ro d yf .
a (Dr. {&. N. Singh)
Drugs Controller Géneral (India)
To
All officers concerned / JDC (I), DDC (I), H.Q & Zonal officers
Copy to:
US (D), MOHFW, Nirman Bhawan, N. Delhi