CDSCO- Functions & Responsibilities
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The Central Drugs Standard Control Organisation (CDSCO) is India's national drug regulatory authority responsible for ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. Its key functions include setting standards, regulating clinical research, approving licenses for manufacturing, and managing imports and exports of drugs. Additionally, the CDSCO has implemented the CDSCO-Sugam project to enhance transparency and streamline regulatory processes in the pharmaceutical industry.
CDSCO- Functions & Responsibilities
- 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