**Summary:**
This notice, dated September 5, 2017, is a continuation of a previous public notice (dated June 2, 2017) issued by the Directorate General of Health Services, Office of Drugs Controller General India. The Directorate initially sought suggestions and comments from stakeholders, including manufacturers and marketers of Hydroxypropyl Methylcellulose (HPMC) capsules, as well as relevant NGOs, regarding the potential replacement of gelatin capsules with cellulose-based capsules for drug encapsulation.
Following the receipt of various comments, the Ministry of Health and Family Welfare has constituted an Expert Committee to examine all aspects related to this proposed replacement and to ensure its sustainability. Stakeholders who have not yet submitted their responses on this issue are requested to submit their comments/representations to the Directorate within 15 days for consideration by the Expert Committee. This call for comments aims to ensure wider consultation on the matter. The contact information for submission is with the Member Secretary, Expert Committee.
Key Entities Referenced
Directorate General of Health Services: An organization; issuing the notice.
Drugs Controller General India: An office under the Directorate General of Health Services.
HPMC capsules: Hydroxyl Propyl Methyl Cellulose capsules; Subject of the notice, regarding suggestions/comments from stakeholders.
NGOs: Non-governmental organizations; Invited to provide suggestions/comments.
Ministry of Health and Family Welfare: The ministry that has received representation related to replacement of Gelatin Capsules.
Expert Committee: A committee constituted to consider the issue pertaining to replacement of Gelatin Capsules.
Gelatin Capsules: Capsules being considered for replacement with cellulose based capsules.
cellulose based capsules: Proposed replacement for Gelatin Capsules.
File No. 4-01/2013-DC (Misc. 45)
Directorate General of Health Services
Office of Drugs Controller General (India)
Pated: 05 SEP 2017
NOTICE
This is in continuation to this Directorate earlier public notice dated 02.06.2017,
whereby suggestions/comments of the Stakeholders including manufacturers/marketers of
HPMC capsules as well as NGOs who are working in this subject were invited.
This Directorate has received various comments from different stakeholders and
t Mh ine
i
ss ta rym e
o f
w Ha es
a
lp tl ha c ae nd
d
b Fe af mo ir le
y
t Wh ee
l
fE ax rp ee rt
to
C ao dm dm ri et st se e
al l
co tn hs et i tt eu ct he nd
i
cf ao lr it sh se
u
ep su r pp eo rs tae
i
nb iy
n
gt h te
o
replacement of Gelatin Capsules with cellulose based capsules for encapsulation of drugs.
The Committee has desired that those Stakeholders who have not yet made
ar le sp or e ss ue bn mt ia tti to hn es
i r
a cn od
m
ma er ne
t
sw /i rll ei pn rg esto
e
np tr ae ts ie on nt
s
t sh oei r
t
hac ta s ae
c
ob ne sf ior de
e
rt eh de viEx ep we crt
a
nC bo em m ti at kt ee ne
i
nm ta hy
e
matter.
In order to have wider consultation, comments/representations are invited from
such stakeholders within 15 days who are working in this subject and have not yet
submitted their comments so far to this Directorate.
(Member Secretary, Expert Committee)