Functions and Responsibilities of CDSCO: Drug Regulatory Authority in India

Central Drugs Standard Control Organisation Functions & Responsibilitie

What is CDSCO .?? It is the National Drug Regulatory Authority of the Government ofIndia. 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 CosmeticsAct.

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

Functions of CentralAuthority 1.Layingdownstandardsof drugs,cosmetics,diagnosticsand devices. 2. Layingdownregulatory measures,amendmentstoActsand Rules. 3. T oregulatemarket authorisation of newdrugs. 4. T oregulateclinical researchin India. 5.T o approve licenses to manufacture certain categories of drugs as Central Licence approvingAuthority i.e.for BloodBanks,LargeVolumeParenteralandVaccines &Sera. 6. T o regulate the standards of imported drugs. 7.Work Consultative Committee(DCC). relating to the Drugs Technical Advisory Board (DTAB) and Drugs 8. Testing of drugs by Central Drugs Labs 9. Publication of Indian Pharmacopoeia.

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.

Port Offices ofCDSCO Functions of Scrutiny of bills of entry with a view to ensuring that imported drugs comply with the regulations. T o check the shipping bills for export for statistical data and keep control under the regulations T o 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. T o ensure that small quantities of drugs imported for clinical trials or for personal use are duly permitted under T est License (11 or 11-A) or Permit License as (12 B) as the case maybe. Maintenance of Statistics regarding import and export of drugs and cosmetics. Coordination with Customsauthorities. Coordination with States Drugs Controllers and Zonal Offices for post-import checks. Preparation of monthly / quarterly / annual reports. T o draw samples from import/export and re-import consignments.

Responsibilities Of StateAuthority 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

Responsibilities Of CentralAuthority Approval of NewDrugs Clinical Trials in the country Laying down the standards for Drugs Control over the quality of imported Drugs Coordination of the activities of State DrugC O Providing expert advice with a view of bringing about the uniformity in the enforcement of the Drugs and CosmeticsAct

Approval of New Drugs

Clinical Trial In the past, the regulatory pathway for clinical trial was simple with a single tier approvalprocess. In March 2011, C D S C O constituted 12 New Drug Advisory Committees Known as SubjectExpert Committees (SEC) 3 Tier Review Process

Medical Devices NewGuidelines were effective from Jan 1, 2018 Class A- Low Risk (Thermometer,Tongue Depressor) The Risk based Class B- Low Moderate Risk(Suction classification for medical Equipment, Hypodermic Needle) devices Class C-High Moderate Risk (Ventilator, Bone FixationPlate) Class D- High Risk (Heart Valves)

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 DIGIT AL INDIA initiatives It is a major influence in bringing reforms in the Indian PharmaIndustry The prime objectives of the project are: T o establish a single window for multiple stakeholders involved in the processes of C D S C O . T o consolidate the Indian Drug Regulatory Framework by streamlining the C D S C O processes. T o enable paperless grant of various clearances by C D S C O . T o enable higher level of transparency in Drug regulatory processes. T o enable ease of business for Pharmaceutical Industry & regulatoryagency. T o enable the greater outreach of citizen centric & consumer centric information related to quality and standard of drugs in the country.

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

Thank You