**Summary:**
This notice, issued by the Drugs Controller General of India (DCGI) on October 5, 2017, outlines the procedure for subsequent applicants seeking approval for Fixed Dose Combinations (FDCs) that have been declared rational by the Kokate Committee and approved by the DCGI. The notice refers to previous directives issued on January 15, 2013, March 16, 2017, and June 5, 2017, regarding this matter. It clarifies the requirements for applicants who intend to manufacture and market FDCs already deemed rational. Such applicants must submit their applications along with relevant data to demonstrate the safety and efficacy of their specific FDC formulation, even if the FDC has already been approved for other manufacturers. The notice is addressed to all State/Union Territory Drugs Controllers and Zonal/Sub-Zonal offices of the Central Drugs Standard Control Organization (CDSCO). Copies have also been sent to the PS to JSR, Ministry of Health and Family Welfare, and various drug manufacturing associations, including IDMA, OPPI, IPA, and FOPE. Dr. G.N. Singh, Drugs Controller General of India, is the contact person for this notice. The File No. is 4012013DC Mise. 13PSC.
Key Entities Referenced
Drugs Controller General India: Designation of the officer issuing the notice, part of Directorate General of Health Services.
FDCs: Fixed Dose Combinations, referring to pharmaceutical products.
Kokate Committee: A committee that evaluated the rationality of FDCs (Fixed Dose Combinations).
DCGI: Drugs Controller General of India, the authority approving the recommendations of the Kokate Committee regarding FDCs.
Directorate General of Health Services: The parent organization of the Office of Drugs Controller General India.
FDA Bhawan, Kotla Road, New Delhi: Location of the Office of Drugs Controller General India.
CDSCO: Central Drugs Standard Control Organization, zonal and sub-zonal offices are mentioned.
Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi: A governmental organization to which copy of the notice is addressed
File No. 4-01/2013-DC (Mise. 13-PSC)
Directorate General of Health Services
Office of Drugs Controller General (India)
(FDC Division)
FDA Bhawan, Kotla Road
; New Delhi-110002
Pared: 5 OCT 201)
NOTICE
Subject: Procedure to be followed for subsequent applicants in respect of FDCs declared as
rational by Kokate Committee and approved by DCGI-regarding.
References: 1. This Directorate’s letter no. 4-01/2013-DC (Mise. 13-PSC) dated 15.01.2013. 2.
This Directorate’s notice no. 4-01/2013-DC (Mise. 13-PSC) dated 16.03.2017.
3. This Directorate’s notice no. 4-01/2013-DC (Mise. 13-PSC) dated 05.06.2017.
rp aa tt ih onw aa ly T b h f yi o s r P ri c os l f e .i a n Kr c a oo n kn c at e ti eon u f Ca c ot a mi so men is t t wo ti et t eh hi s ar neD dsi pr aee pcc ptt ro t or oa v t s ee u d b n bso yet qi Duce Ce n Go tf I a e p wv p ae l sn i c cn a lnu at rm s ib f iie enr d .r d ea st pee cd t 0 o5 f. 0 F6 D. C20 s1 7 d ew ch lae rr ee db y a
aaL ppi ppc lle iin ccs aai ttI n iit g
oo
nw nA ssa u s wt
t
i
h
o
la o ll r ts i nho t
i
o
sy tr e bf Dq o eiu r re cess ocut ntce sod h
ir a
dt F
t
eh D
e
ra et C
a
dsa
t
l
a
l a
nt
nt
h
ddh
e
e
t
d
h
em ei
a
ia d
r
r
ln n iu lo ef ist ca
t
ec o nt b
b
su t
u
ear
t
sie n wr
n
is oN
l
t
lw O bh lC
a
eo
t e
cf ra or r noe
t
sm
h
ia
a
dl D
n
er C re 4G ea dd I my
a
oa sh nr o
t
wel
h
id r
s
tei
,
hqn
o
ug ufi tarl iei lldc eie gntn agoc
l
e s
w
v
u ahf lb ir im co di ihm t
t y
S tt ,t hha eet ii re r
dap op wli nc a ut nI i dn o
e
nv rsi te s hhw ia
s
l o Dlf
i
rsa eub cbo tmv oie r, t
a
ti t et h
’
e sis nsa oag tma ii cen
e
t or o fe q t eu h vie ess nt D e nid r
u
e mt ch bta eot r rs a u t de ac th w
e
i dm t a 0hn 5iu .nf
0
a 62c
.
t 2mu 0or 1ne 7r t .s h sw h aso pa er re ty he et t po r os cu eb dm ui rt e t lh ae ii dr
Yours faithfully,
(Dr. G. Nj Singh)
Drugs Controller General (India)
To:-
All State/UT Drugs Controllers/All Zonal/Sub Zonal offices of CDSCO.
Copy to:-
1. PS to JS(R), Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi.
2. Drug Manufacturing Associations: IDMA/OPPI/IPA/CIPI/FOPE
ete,