The document outlines the functions and structure of the Central Drugs Standard Control Organization (CDSCO), India's national regulatory authority for pharmaceuticals. CDSCO regulates drugs, cosmetics, and medical devices in India to ensure quality, safety and efficacy. It has a central office and several zonal, sub-zonal and port offices. CDSCO sets standards, approves new drugs, regulates clinical trials and imports/exports. It works jointly with state drug authorities on licensing, inspections, and quality monitoring.
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
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
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
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?Ajay kamboj
CoPP is necessary for exporting medicines and pharmaceutical products from India. The application for grant of WHO GMP Certificate of Pharmaceutical Product shall be made to respective zonal/sub zonal officers appointed by DCGI as per the requirement.
A detailed study on the guidelines that are taken for ICH which is also known as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The chapter deals with an overview of Quality, Safety, Efficacy and Multidisciplinary guidelines and then a detailed study on the Quality Guidelines. Also a detailed learning of Stability Testing Guidelines proposed by the International Conference for Harmonization.
A brief introductory presentation about National Drug Regulatory Authority of India for Indian Pharmaceuticals and Medical Devices i.e. CDSCO. By Pratibha Chaudhary, pursuing Mpharm DRA from Amity University.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?Ajay kamboj
CoPP is necessary for exporting medicines and pharmaceutical products from India. The application for grant of WHO GMP Certificate of Pharmaceutical Product shall be made to respective zonal/sub zonal officers appointed by DCGI as per the requirement.
A detailed study on the guidelines that are taken for ICH which is also known as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The chapter deals with an overview of Quality, Safety, Efficacy and Multidisciplinary guidelines and then a detailed study on the Quality Guidelines. Also a detailed learning of Stability Testing Guidelines proposed by the International Conference for Harmonization.
A brief introductory presentation about National Drug Regulatory Authority of India for Indian Pharmaceuticals and Medical Devices i.e. CDSCO. By Pratibha Chaudhary, pursuing Mpharm DRA from Amity University.
-The Central Drug Standard Control Organization (CDSCO) is the main regulatory body of
India for regulation of Pharmaceutical, medical and clinical trials.
➢ The head office of CDSCO is located in New Delhi and it is functioning under the Control
of Directorate General of Health Services, Ministry of Health and Family Welfare,
Government of India.
➢ The CDSCO works with the World Health Organization to promote Good Manufacturing
Practice (GMP) and international regulatory harmony.
➢ It is the central drug authority for discharging functions assigned to the Central Government
under the Drug and Cosmetics Act.
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
Indian Regulatory Requirements: Central Drugs Standard Control Organization (CDSCO). The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics. Vision:
To Protect and Promote public health in India.
Mission:
To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. Functions of CDSCO
Certificate of Pharmaceutical Product (COPP): The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO).
COPP establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country.
It is often mentioned in conjunction with the electronic Common Technical Document (eCTD). The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country. The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country.
COPP Importance: It is needed by the importing country when the product in question is infected for Registration (Licensing and Authorization) or renewal of registration.
With the scope of commercialization or distribution in that country.
Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as a prerequisite of registration or importation. General Requirements for Submission of Application for Issue of COPP. Documents Required for Applying for Grating or
Revalidation of COPPS:
Application from the manufacturer.
Site master file (as specified under WHO TRS 823).
Cost of manufacturing license.
List of approved products.
List of products applied for issuance of COPPS.
List of SOPs and STPs.
Stability data (3 batches) accelerated/Real-time.
List of equipments and instruments.
List of technical staff, their qualification, and experience, and approval status.
Manufacturing layout plan.
Process validation for 3 batches of each product.
Schematic diagram of water system specifying circulation loop and MOC (Material of construction).
Schematic diagram of HVAC system specifying terminal filter configuration. Export data of the last 2 years in case of revalidation.
Flow chart
An Overview of CDSCO Registration. The CDSCO stands for Central Drugs Standard Control Organisation is the NRA or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare.
My presentation based on the CDSCO certification, as well as the complete description about the CDSCO and DCGI.
An Overview of CDSCO Registration. The CDSCO stands for Central Drugs Standard Control Organisation is the NRA or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare.
My presentation based on the CDSCO certification, as well as the complete description about the CDSCO and DCGI.
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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.
4.
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)
9.
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.
11.
12.
13.
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
18.
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
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)
27.
28.
29.
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.
31.
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.
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
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.