**Summary:**
This notice, issued by the Central Drugs Standard Control Organisation (CDSCO) on December 2nd, 2016, announces a review of its eGovernance project and seeks stakeholder feedback on the effectiveness of its online systems and various regulatory activities. The CDSCO is soliciting responses regarding the processing and approval of applications through the online system Sugam, risk-based inspections, NRA assessment through the WHO, lot release by CDL Kasauli, skill development initiatives for regulators and laboratory officials, the DCG Cell for addressing grievances, and amendments in DC Act Rules, Medical Device Rules, Cosmetics, and Clinical Trials. Stakeholders are invited to furnish their responses, and further information can be found on the CDSCO website (www.cdsco.nic.in). The notice was distributed to all State/UT Drug Controllers, Pharma Associations, and other stakeholders. Contact person is S.K. Anwar, DDA.
Key Entities Referenced
CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India, under the Ministry of Health & Family Welfare.
eGovernance project of CDSCO: An initiative by CDSCO to perform its mandated functions online.
Sugam: Online system for processing and approval of applications at CDSCO.
WHO: World Health Organization, assessing NRA (National Regulatory System).
National Regulatory System: A system assessed by WHO, for Regulatory Inspection Process of Registration and marketing approval.
CDL, Kasauli, Himachal Pradesh: Central Drugs Laboratory, Kasauli, responsible for lot release.
DC Act Rules: Drugs and Cosmetics Act Rules, subject to amendment.
State UT Drug Controllers: Drug Controllers of all States and Union Territories of India.
F. No. D.21013/230/2016-Dc
CEN DT IR RA EL
C
D TR OU RG AS
T
ES T GA EN ND EA RR AD
L
C OFO N HT ER AO LL
T
HO R SG EA RN VI IS CA ET SION
FDA Bhawan, Kotla Road,
New Delhi
2nd December, 2016
NOTICE
Under the ongoing e-Governance project of CDSCO, most of its mandated
functions are currently being performed online. Since the system has been in
Place for some time now, it has been felt desirable to elicit response from
various stakeholders about the extent of relief/fa ilities this system has
actually generated. Further, to bring out improvement in functioning of various
regulatory activities at CDSCO, it has been decided to elicit response from
stakeholders. The response may thus be furnished on following points:-
{Processing
and approval of applications through online system ice.
Sugam;
(i) Risk based inspections started in the country;
(ili) NRA assessment through WHO for different functions like
National Regulatory System,
- Regulatory Inspection
~ Process of Registration and marketing approval.
~ Lot release by CDL, Kasauli ete.
@) Skill development exercise started by CDSCO by imparting training
fo CDSCO regulators, State regulators and laboratory officials:
TM) — DCG() Cell for addressing Grievance /Complaints;
(vi) Amendment in
- D&C Act & Rules.
- Medical Device Rules
- Cosmetics
- Clinical TrialN2. o tiT ch ee r he as vp io nn gs e bi en
e
nq ues pt oi so tn
e
dm a oy
n
ple Ca Ds Se
C
b Oe
'
sf ur wn ei bs sh ie td
e
w it ah tin w0 w3
w
.w ce dse ck os
.
no if
c
t .h ii ns
(S.K.
‘anwar]
To DDA (D)
(i) All State/ UT Drug Controllers.
(ii) All Pharma Associations
(iii) Others Shekehelders
Copy to:-
(i) PPS to JS (KLS).
(ii) Staff of DCG (1).
(iii) Director (Admn.)
(iv) Guard file.