for mpharm

1. MR. SANDIP N MAVCHI
FIRSTYEAR M.PHARMACY (QA)
SVBCP DOMBIVLI
SEMINAR ON CDSCO
Guided by Prof.Vaibhav kulkarni sir

2. SEMINAR OUTLINE..
 What is CDSCO.?
 Vision, MissionValues and strategies.
 Hierarchy of CDSCO.
 Head office and zonal offices .
 Functions of CDSCO.
 Functions of central authority.
 Functions of State Authority.
 Functions of Port Offices of CDSCO
 Joint responsibilities of CDSCO and SLAs.
 New and investigational drug application and approval process.
 Three tier review process.
 Medicl devices and diagnostics.
 CDSCO-Sugam
 BA/BE tests application.
 Clinical trials.
 CDL and its fuctions.
 Refrences.

3. What is CDSCO….??
It is the National Drug Regulatory Authority
of the Government of India.
Central Drugs Standard Control Organization
(CDSCO) exercises regulatory control over the
quality of drugs, cosmetics and notified
medical devices in the country.
It is the Central Drug Authority for
discharging functions assigned to the Central
Government under the Drugs and Cosmetics
Act.

5. To Protect and
Promote public
health in India.
To safeguard and
enhance the public
health by assuring the
safety, efficacy and
quality of drugs,
cosmetics and medical
devices.

6. To achieve the mission and mandate of the CDSCO
we will strive to act with
Transparency,
Accountability,
Punctuality,
Courtesy,
Openness,
Responsiveness,
Professionalism,
Impartiality,
Consistency,
IntegrityAnd
Truthfulness.

7. Strategies
Initiate in framing of rules, regulations and guidance
documents to match the contemporary issues in
compliance with the requirements of Drugs & Cosmetics
Act 1940 and Rules 1945.
Facilitate in Uniform implementation of the provisions
of the Drugs & Cosmetics Act 1940 and Rules 1945.

8. Hierarchy
•
Indian government
Ministry of health and family planning
and welfare
Drugs controller general of India
Joint drugs controller (2)
Deputy drugs controllers ( 10)
Assistant drugs controllers(25)
Director administration
Deputy director(Adm)
Section officer (Adm)

10. HEAD OFFICES AND ZONAL
OFFICES
The Central Drugs Standard Control Organization
(CDSCO) is the Central Drug Authority for discharging
functions assigned to the Central Government under the
Drugs and Cosmetics Act.
CDSCO has six zonal offices,
four sub-zonal offices,
13 port offices and
seven laboratories under its control.

14. Oversight and market Surveillance through
Inspectorate of Centre Over and above the
State Authority.

15. 1.Laying down standards of drugs, cosmetics,
diagnostics and devices.
2.Laying down regulatory measures, amendments to
Acts and Rules.
3.To regulate market authorization of new drugs.
4.To regulate clinical research in India.
Functions of central authority

16. 5.To approve licenses to manufacture certain
categories of drugs as Central Licence
approving Authority i.e. for Blood Banks, Large
Volume Parenteral and Vaccines & Sera.
6.To regulate the standards of imported drugs.
7.Testing of drugs by Central Drugs Labs.
8.Publication of Indian Pharmacopoeia.

17.  Licensing of drug manufacturing and
sales establishments.
 Licensing of drug testing laboratories.
 Approval of drug formulations for
manufacture.
 Monitoring the quality of Drugs &
Cosmetics, manufactured by respective
state units and those marketed in the
state.
Functions of State Authority

19. Functions of State Authority
 Investigation and prosecution in respect
of contravention of legal provisions.
 Administrative actions.
 Pre- and post- licensing inspection
 Recall of sub-standard drugs.

20. Scrutiny of bills of entry with a view to ensuring that
imported drugs comply with the regulations.
To check the shipping bills for export for statistical data
and keep control under the regulations
To ensure that no New Drug is imported into the
country unless its import is permitted by the Drugs
Licensing Authority under Rules 122 A & 30-AA.
To ensure that small quantities of drugs imported for
clinical trials or for personal use are duly permitted under
Test License (11 or 11-A) or Permit License as (12 B) as
the case may be.
Functions of Port Offices of CDSCO

21. Functions of Port Offices of
CDSCO
Maintenance of Statistics regarding import and export of
drugs and cosmetics.
Coordination with Customs authorities.
Coordination with States Drugs Controllers and Zonal
Offices for post-import checks.
Preparation of monthly / quarterly / annual reports.
To draw samples from import/export and re-import
consignments

22. state licensing
authorities

26.  New Guidelines were effective from Jan 1, 2018
 The Risk based classification for medical devices
 Class A- Low Risk (Thermometer,Tongue Depressor)
 Class B- Low Moderate Risk (Suction Equipment,
Hypodermic Needle)
 Class C-High Moderate Risk (Ventilator, Bone Fixation Plate)
 Class D- High Risk (HeartValves)

30. CDSCO-Sugam
This project has brought simplicity,
transparency, reliability, accountability,
timeliness and also simplified ease of business.
It is the project of national importance that
directly reflects the Governments DIGITAL
INDIA initiatives.
It is a major influence in bringing reforms in
the Indian Pharma Industry.

32. FOR BA/BETESTS APPLICATION
The applicants submit the application for BE NOC &Test
Licence through online Sugam Portal in applicable
checklist.
The application will be processed by the Assistant Drugs
Inspector/Drugs Inspector (Reviewing Officer) and send to
the ADC(I) (Nodal Officer) for further review.
The Nodal Officer will send the application to DDC(I)
(Deputy Decision Authority)/JDC(I) (Decision Authority)
for recommendation for approval then DCG(I) (Licensing
Authority) will grant the BE NOC &Test Licence to the
applicant through Online Sugam Portal.

34. FLOW CHART FOR BA/BETEST APPLICATION

36. Application forwardedto
Reviewing Officer
After review forwarded to NO
After review forwarded to
DDA/DA
If any deficiency
in documents
Query
If all the documents are in Order
Forwarded to LA
Approval
Application received by Nodal
Officer
Online submission of application with
requisite documents
Approval process for Post Approval Application received Online Sugam Portal with respect
to Global Clinical Trials Division.
Applicant

40. Central DrugTesting Laboratories

41.  Analytical quality control of majority of the imported Drug
available in Indian market.
Analytical quality control of drug and cosmetics
manufactured within the country on behalf of the Central and
State Drug Controller Administrations.
Preparation of National Reference Standards and
maintenance of such Standards. Maintenance of microbial
cultures useful in drug analysis Distribution of Standards and
cultures to State Quality Control Laboratories and drug
manufacturing establishments.
Training of Drug Analysts deputed by State Drug Control
Laboratories and other Institutions.

42. Training of World Health Organization Fellows from
abroad on modern methods of Drug Analysis.
To advise the Central Drug Control Administration in
respect of quality and toxicity of drug awaiting license.
To work out analytical specifications for preparation of
Monographs for the Indian Pharmacopoeia and the
Homoeopathic Pharmacopoeia of India.
To undertake analytical research on standardisation and
methodology of Drug and cosmetics.

43. Analysis of Cosmetics received as
survey samples from Central Drug
Standard Control Organization.
Quick analysis of life saving Drug on an
All-India basis received under National
Survey of Quality of Essential Drug
Programme from Zonal Offices of
Central Drug Standard Control
Organization.

44. References
https://www.slideshare.net/viveksachithananthan/cdsco-a-regulatory-overview
http://www.jli.edu.in/blog/roles-and-responsibilities-of-cdsco/
http://cdsco.nic.in/writereaddata/Guidance%20documents.pdf
https://www.slideshare.net/bdvfgbdhg/central-drug-standard-control-
organisation
http://www.cdsco.nic.in/writereaddata/Scan1.pdf
https://cdsco.gov.in/opencms/opencms/en/Home/
https://cdscoonline.gov.in/CDSCO/homepage

45. THANKYOU