This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM

1. Central Drugs Standard
Control Organisation
CENTRAL DRUGS
STANDARD CONTROL
ORGANISATION
Functions & Responsibilities
Presented By: Bindu
Research Scholar

2. • 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.
What is CDSCO….??

3. Mission:
To safeguard and enhance the public health by assuring the
safety, efficacy and quality of drugs, cosmetics and medical
devices.
Vision:
To Protect & Promote Health in India

4. Functions of Central Authority
1. Laying down standards of drugs, cosmetics, diagnostics and devices.
2. Laying down regulatory measures, amendments to Acts and Rules.
3. To regulate market authorisation of new drugs.
4. To regulate clinical research in India.
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. Work relating to the Drugs Technical Advisory Board (DTAB) and Drugs
Consultative Committee (DCC).
8. Testing of drugs by Central Drugs Labs
9. Publication of Indian Pharmacopoeia.

5. Functions of State Authority
1.Licensing of drug manufacturing and sales establishments
2. Licensing of drug testing laboratories.
3. Approval of drug formulations for manufacture.
4. Monitoring of quality of Drugs & Cosmetics, manufactured by respective state
units and those marketed in the state.
5. Investigation and prosecution in respect of contravention of legal provisions.
6. Administrative actions.
7. Pre- and post- licensing inspection
8. Recall of sub-standard drugs.

6. •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.
•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.
Functions of Port Offices of CDSCO

7. Responsibilities Of State Authority
Manufacturing
Sale
Distribution of Drugs
• Manufacturing, sales, distribution of Drugs
licensing drug testing laboratories.
• Approving drug formulations for manufacture
• Carrying out pre- and post-licensing inspections
• Overseeing the manufacturing process for drugs
manufactured by respective state units and
those marketed in the state

8. Responsibilities Of Central Authority
• Approval of New Drugs
• Clinical Trials in the country
•Laying down the standards for Drugs
•Control over the quality of imported Drugs
•Coordination of the activities of State Drug CO
• Providing expert advice with a view of bringing about the
uniformity in the enforcement of the Drugs and Cosmetics Act

10. Approval of New Drugs

11. Clinical Trial
In the past, the regulatory pathway for clinical trial was simple with a single tier approval process.
In March 2011, CDSCO constituted 12 New Drug Advisory Committees Known as Subject Expert
Committees (SEC)
3
Tier
Review
Process

12. Medical Devices
New Guidelines were effective from Jan 1, 2018
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 (Heart Valves)
The Risk based
classification for medical
devices

13. 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
• To establish a single window for multiple stakeholders involved in the processes of CDSCO.
• To consolidate the Indian Drug Regulatory Framework by streamlining the CDSCO processes.
• To enable paperless grant of various clearances by CDSCO.
• To enable higher level of transparency in Drug regulatory processes.
• To enable ease of business for Pharmaceutical Industry & regulatory agency.
• To enable the greater outreach of citizen centric & consumer centric information related to quality and standard of
drugs in the country.
The prime objectives of the project are:

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

15. Thank You