The document provides a comprehensive overview of the Central Drugs Standard Control Organization (CDSCO) in India, detailing its structure, functions, and regulatory guidelines for pharmaceuticals, medical devices, cosmetics, and clinical trials. It describes the CDSCO's role in ensuring safety and efficacy in drug approval processes, the organization of its operations including zonal offices and laboratories, and specific guidelines for various applications including the Common Technical Document (CTD). Additionally, it outlines the import regulations for cosmetics and the classification and approval processes for medical devices and clinical trials.

1. Presented by-
Ms. Varsha R Wadnere {PD539}

2. Content
❖ Introduction
❖ Organization
❖ Functions
❖ Guidelines
❖ Common Technical Document(CTD)
❖ Cosmetics
❖ Medical Devices
❖ Clinical Trials

3. ❖ Introduction
• The Central Drugs Standard Control Organization is the national regulatory body for Indian
pharmaceuticals and medical devices, and serves parallel function to the European Medicines
Agency of the European Union, the Pharmaceutical and Medical Devices Agency (PMDA) of Japan
and the Food and Drug Administration of the United States.
• It’s Head quarter is located at FDA Bhawan, Kotla Road, New Delhi and functions under the
Directorate General of Health Services.
• Within the CDSCO, the Drug Controller General of India (DCGI)regulates pharmaceuticals and
medical devices.
• The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative
Committee (DCC).
• It is divided into zonal offices which do pre-licensing and post-licensing inspections, post-market
surveillance, and recalls when needed.

6. Laboratories Of CDSCO
➢ Six laboratories-
• Central Drugs Laboratory (CDL) Kolkata
• Central Drugs Testing Laboratory (CDTL) Chennai
• Central Drugs Testing Laboratory (CDTL) Mumbai
• Regional Drug Testing Laboratory (RDTL) Guwahati
• Regional Drug Testing Laboratory (RDTL) Chandigarh
• Central Drugs Laboratory (CDL) Kasuali

8. ❖ SUGAM {online licensing portal} –
An online licensing portal of CDSCO to file application for various services like application
submission, processing and grant of permission for quick delivery of services.
SUGAM Benefits:
• Applicant can apply license under import and registration division to CDSCO.
• Track the status of application through online. Answer back to raised queries.
• Applicant can also upload essential documents for registration import license and other
related activities.

10. ❖ Guidelines
➢ Various guidelines are included-
• Guidelines for new drug
• Guidelines for medical devices and diagnostics
• Guidelines for cosmetics
• Guidelines for biological
• Guidelines for clinical trials
• Guidelines for BA BE studies
• Guidelines for post approval changes.
• Guidelines for import, manufacturing, sale and distribution of drugs, cosmetics, medical devices, biologicals etc.
• Guidelines for blood banks.

11. ❖ Common Technical Document- Guideline (CTD)
• Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product
can be approved for import or manufacturing of new drug by the applicant by CDSCO. The regulations under
Drugs and Cosmetics Rules 122A, 122B and 122D and further Appendix I, IA and VI of Schedule Y, describe
the information required for approval of an application to import or manufacture of new drug for marketing.
• Substantial documentation for such types of submissions are required, creating number of hurdles and resulting
in unnecessary delay in approval. So the common format for submission was developed through The
International Council for Harmonisation (ICH) for Japan, EU, and US called CTD (common technical
document).

12. Guidelines For Preparation Of CTD
➢ Five Modules-
Module 1: General Information
Module 2: CTD Summaries
Module 3: Quality
Module 4: Non-clinical Study reports
Module 5: Clinical study reports

13. Module 1:General Information
➢ Contains-
• Covering letter & comprehensive table of contents
• Administrative information(contains intro. about applicant company, filled form 44, challan, information of
coordinates etc.)
• General information on drug product
• Summary of testing protocols
• Regulatory status in other country

14. Module 2:CTD Summaries
➢ Contains-
• Table of contents
• Introduction
• Quality overall summery(QOS)
• Non clinical overview
• Clinical overview
• Nonclinical written and tabulated summaries
• Clinical summery

15. ❖ Module 3: Quality
➢ Contains-
▪ Table of contents
▪ Body of data- Contains detailed information pertaining to quality of
• Drug substance(s)
• Drug product
• Excipients
• Facility & equipment

16. ▪ Drug substance(s) (contains information about)
• General information
• Manufacturing of drug substance
• Characteristic of drug substance
• Quality control of drug substance
• Reference standard materials
• Container closure system Stability of drug substance

17. ▪ Drug product
• Composition of drug product
• Pharmaceutical development of drug product
• Manufacturing of drug product Control of excipients
• Control of drug product Reference standard material
• Container closure system
• Stability of drug product

18. Module 4:Non-Clinical Study Report
▪ Table of contents
▪ Study reports
- Pharmacology
• Primary Pharmacodynamics,
• Secondary Pharmacodynamics
• Safety Pharmacology
• Pharmacodynamic Drug Interactions

19. - Pharmacokinetics
- Toxicology
• Single-Dose Toxicity
• Repeat-Dose Toxicity.
• Carcinogenicity
• Reproductive and Developmental Toxicity • Other Toxicity Studies (if available), for example
i. Antigenicity
ii. Immunotoxicity

20. Module 5:Clinical Study Report
▪ Contains-
• Table of contents
• Tabular listing of all clinical studies
• Clinical study reports
▪ Reports of BA BE, IVIVC studies
▪ Reports of PK-PD studies
▪ Reports of efficacy & safety
▪ Reports of post marketing experience

21. Diagrammatic Representation of Organization of CTD

22. ❖ Cosmetics
➢ Import
• Statement to accompany imported cosmetics-
All consignments of cosmetics sought to be imported shall be accompanied by an invoice or statement showing the
name and quantities of each article of cosmetic included in the consignment and the name and address of the
manufacturer.
• Documents to be supplied to the Collector of Customs-
Before any cosmetics are imported, a declaration signed by or on behalf of the manufacturer or by or on behalf of
the importer that the cosmetics comply with the provisions of Chapter III of the Act, and the rules made there under,
shall be supplied to the Collector of Customs.

23. • Procedure for the import of cosmetics-
✓ If the officer appointed at the post of entry by the Central Government has reason to believe that any cosmetic
contravenes any of the provisions of the Act or the rules made there under he may take sample of the cosmetic
from the consignment for inspection. If on examination of the sample defects are noticed the officer shall advice
the Commissioner of Customs for further action to be taken.
✓ If there is suspected contravention of the provisions of the Act the officer shall send the sample to the laboratory
established for the purpose for performing tests. The consignment of the said cosmetic shall be detained till such
time that the test report on such sample is received from the Director of the said laboratory or any other officer of
the laboratory empowered by him in this behalf with the approval of the Central Government.

24. • Exemption of cosmetics-
Cosmetics as may be specified in Schedule D shall be exempted from the provisions of Chapter III of the Act and the
rules made there under to the extent and subject to the conditions specified in that Schedule.
• Import through points of entry-
No cosmetic shall be imported into India except through the points of entry specified in Rule 43-A.
• Cosmetic containing Dyes, Colours and Pigments-
No Cosmetic shall contain Dyes, Colours and Pigment other than those specified by the Bureau of Indian Standards
(IS: 4707 Part I as amended) and Schedule Q

25. The permitted Synthetic Organic Colours and Natural Organic colours used in the Cosmetics shall not
contain more than-
i) 2 parts per million of Arsenic calculated as Arsenic Trioxide.
ii) 20 parts per million of Lead calculated as Lead
iii) 100 parts per million of Heavy Metals other than Lead calculated as the total of the respective metals.
• Prohibition of import of cosmetic containing hexachlorophene-
No cosmetic containing hexachlorophene shall be imported.
• Import of cosmetics containing mercury compounds prohibited-
No cosmetic shall be imported which contains mercury compounds.

26. ❖ 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:
i. Class A- low risk (thermometer, tongue depressor)
ii. Class B- low moderate risk (suction equipment, hypodermic needle)
iii. Class C- high moderate risk (bone fixation plate)
iv. Class D- high risk (heart valves)

27. ❖ Clinical Trials
• An application to conduct clinical trials in India should be submitted along with the data of chemistry,
manufacturing, control and animal studies to DCGI.
• The date regarding the trial protocol, investigator's brochures, and informed consent documents should also be
attached.
• A copy of the application must be submitted to the ethical committee and the clinical trials are conducted only
after approval of DCGI and ethical committee.
• To determine the maximum tolerated dose in humans, adverse reactions, etc. on healthy human volunteers,
Phase I clinical trials are conducted.

28. • The therapeutic uses and effective dose ranges are determined in Phase II trials in 10-12 patients at each dose
level.
• The confirmatory trials (Phase III) are conducted to generate data regarding the efficacy and safety of the drug
in- 100 patients (in 3-4 centers) to confirm efficacy and safety claims.
• Phase III trials should be conducted on a minimum of 500 patients spread across 10-15 centers

30. ➢ Documents reviewed by CDSCO before approving to Clinical
trails:
a) Investigational pharmaceutical product
b) Pre-clinical supporting data
c) Protocol
d) Ethical safety considerations:
i. Ethical principles
ii. Ethical committee
iii. Informed consent form
iv. Confidentiality of subjects
v. Compensation for participants
vi. Selection of special groups as research subjects

31. i. Pregnant/nursing women
ii. Children
iii. Vulnerable groups
➢ Responsibilities of persons who are conducting the clinical trials
a) Sponsor-responsibilities
b) Investigator-qualifications & responsibilities
c) Monitor-qualifications & responsibilities

32. ➢ Record keeping & data handling
a) Documentation
b) Corrections
c) Electronic data processing
d) Language
e) Responsibilities of sponsor, investigator, monitor
➢ Quality assurance
Quality Assurance (QA) in clinical trials consists of planned, systematic activities that
are conducted to ensure that a trial is performed and that trial data are generated,
documented, and reported in compliance with the protocol, Good Clinical Practice
(GCP) guidelines, and all other applicable regulatory requirement(s).