CDSCO GUIDELINES
Presented By : Heli V. Patel
M.Pharm Sem 1 RA
EN. No. 92301299001
Subject: CRR (13MR0103)
Under Guidance By Nasir H. Vadia
Department of Pharmaceutical sciences,
Faculty of health sciences.
Marwadi University, Rajkot.
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Overview of CDSCO Guidelines: Drug, Clinical Trial, Cosmetic, & Medical Device Regulation, Slides of Pharmacy
Title: Overview of CDSCO Guidelines: Drug, Clinical Trial, Cosmetic, and Medical Device Regulations in India Document Type: PowerPoint Presentation / Academic Seminar Course: Clinical Research and Regulatory Affairs (CRR) Subject Code: 13MR0103 Semester: M.Pharm Semester 1 Academic Year: 2023-2024 This PowerPoint presentation provides a comprehensive overview of the Central Drugs Standard Control Organization (CDSCO)—India's national regulatory authority for pharmaceuticals, medical devices, and clinical trials. Designed for postgraduate pharmacy students, the content is aligned with the syllabus of Clinical Research and Regulatory Affairs and presents well-organized information under key headings.
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2024/2025
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CDSCO GUIDELINES
Presented By : Heli V. Patel M.Pharm Sem 1 RA EN. No. 92301299001 Subject: CRR (13MR0103) Under Guidance By Nasir H. Vadia Department of Pharmaceutical sciences, Faculty of health sciences. Marwadi University, Rajkot.
CONTENT
- (^) Introduction
- (^) Organization
- (^) Function of CDSCO
- (^) Drug Approval Process
- (^) Clinical trials Process
- (^) Cosmetics
- (^) Medical Devices
Vision Mission To protect and promote health in India. To safeguard and enhance the public health by assuring the safety, efficacy, and quality of drugs, cosmetics and medical devices.
Drugs Controller General of India [DCGI]
- (^) He is a responsible for approval of New Drugs, Medical devices and Clinical Trails to be conducted in India.
- (^) He is appointed by the central government under the State drug control organization will be functioning.
- (^) The DCGI (Drug Controller General of India) is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee(DCC).
Zonal office
- (^) Mumbai
- (^) Kolkata
- (^) Chennai
- (^) Ghaziabad
- (^) Ahmedabad
- (^) Hyderabad Sub-Zonal Office
- (^) Chandigarh
- (^) Jammu
- (^) Bangalore Port Office
- (^) Delhi
- (^) Chennai
- (^) Hyderabad
- (^) Indore Port
- (^) Kolkata Port
- (^) Mumbai Port
- (^) Cochin Port
- (^) Vishakhapatna m sea Port
- (^) Krishnapatana m Port Laboratories
- (^) Kolkata
- (^) Kasauli
- (^) Mumbai
- (^) Hyderabad
- (^) Chennai
- (^) Chandigarh
- (^) Guwahati
State Licensing Authority
- (^) Licensing of manufacturing site for drug including API and finished product.
- (^) It give approval of drug testing laboratories.
- (^) Monitoring of quality of drug and cosmetics marketed in the country
- (^) Licensing of establishment for sale or distribution of drug
- (^) Recall of sub-standard drugs.
Drug Approval Process
COSMETICS
- (^) For import of cosmetics in India required to be registered with central drugs standard control organization (CDSCO) by giving application in Form 42 to obtain registration certificate in Form 43.
- (^) The manufactured person / the authorized agent can be an applicant for issuance of registration certificate for import of cosmetics into India.
- (^) License will granted within 6 months.
MEDICAL DEVICES
- (^) Any instrument, apparatus, implement machine, appliance, implant, in vitro reagent used for treatment.
- (^) The import, export, manufacturing of medical devices regulated under drug and cosmetics act & rule
- (^) The risk based classification for medical devices ranging from:
- Class A low risk (thermometer, tongue depressor)
- Class B low moderate risk (suction equipment, hypodermic needle)
- Class C high moderate risk(bone fixation plate)
- Class D high risk (heart valves,)