The document provides information on the Central Drug Standard Control Organization (CDSCO), which is India's main drug regulatory authority. It describes CDSCO's vision, mission, and organizational structure. CDSCO regulates pharmaceuticals, medical devices, and clinical trials in India. It is responsible for drug approval and ensures drugs meet standards of safety, efficacy, and quality. CDSCO oversees various offices across India and has laboratories for drug testing.

1. CENTRAL DRUG STANDARD
CONTROL ORGANIZATION
(CDSCO)
Ms. Mamta Kumari
Assistant Professor
M Pharm (Pharmaceutics)
Department of Pharmacy,
Sumandeep Vidyapeeth Deemed to be University,
Vadodara

2. INTRODUCTION
 The Central Drug Standard Control Organization (CDSCO) is
the main regulatory body of India for regulation of
Pharmaceutical, Medical devices and Clinical trials.
 CDSCO is the Central Drug Authority for discharging function
assigned to the Central Government under the Drug and
Cosmetics Act 1940 and rules 1945.
 Head office of CDSCO is located in New Delhi.
 Functioning under the Control of Directorate General of
Health Services, Ministry of Health and Family Welfare,
Government of India.

3. Vision:
To protect and promote health in India.
Mission:
To safeguard and enhance the public health by assuring to
safety, efficacy and quality of drugs, cosmetics and medical
devices.

4. ORGANIZATION OF CDSCO
Drug Controller General of India (DCGI)
Deputy Drug Controller (INDIA)
Assistant Drug Controller (INDIA)
Medical Device Division Diagnostic Division
Drug Inspectors Technical Data Drug Inspectors
Associates

5. Drug Controller General of India (DCGI)
 He/She is a responsible for approval of New Drugs, Medical
devices and Clinical Trials to be conducted in India.
 He is appointed by the Central Government under the State
Drug Control Organization will be functioning.
 The DCGI is advised by the Drug Technical Advisory Board
(DTAB) and the Drug Consultative Committee (DCC).

6. Zonal offices
 Ghaziabad (North Zone)
 Kolkata (East Zone)
 Mumbai (West Zone)
 Chennai (South Zone)
 Ahmedabad (Zonal Office)
 Hyderabad (Zonal Office)
These are involved in GMP audits and inspection of
manufacturing units of large volume parenteral, sera, vaccine and
blood products.

7. Sub Zonal Offices (7)
 Bangalore
 Varanasi
 Goa
 Jammu
 Indore
 Guwahati
 Baddi
These centre co-ordinate with State Drug Control Authorities
under their jurisdiction for uniform standard of inspection and
enforcement.

8. Port/Air port office (13)
 Delhi
 Chennai (Air & Sea port)
 Kolkata (Air & Sea port)
 Mumbai (Air & Sea port)
 Cochin
 Indore
 Hyderabad
 Vishakhapatnam
 Krishnapatnam
 Ahmedabad

9. Laboratories
 Central Drug Laboratory (CDL), kolkata
 Central Drugs Testing Laboratory (CDTL),
Chennai
 Central Drugs Testing Laboratory, Hyderabad
 Central Drugs Testing Laboratory, Mumbai
 Regional Drugs Testing Laboratory, Guwahati
 Regional Drugs Testing Laboratory, Chandigarh
 Central Drug Laboratory, Kasauli

10. Responsibilities and Functions of CDSCO
 Statutory functions:
1. Forms standards of drugs, cosmetics, diagnostics and devices.
2. Regulatory measures, amendments to Acts and Rules.
3. To regulate market authorization 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 and Sera.
6. To regulate the standards of imported drugs.
7. Works relating to the DTAB and DCC.
8. Testing of drugs by Central Drugs Labs.
9. Publication of Indian Pharmacopoeia.

11. Other Functions:
1. Coordinating the activities of the State Drug Control Organizations to
achieve uniform Administration of the Act and policy guidance.
2. Guidance on technical matters.
3. Participation in the WHO GMP certification scheme.
4. Monitoring adverse drug reactions (ADR)
5. Conducting training programmes for regulatory officials and Govt.
Analysts.
6. Distribution of quotas of narcotic drugs for use in medicinal
formulations.
7. Screening of drug formulations available in Indian market.
8. Evaluation/screening of applications for granting No objection
certificates for export of unapproved/banned drugs.

12. STATE LICENSING AUTHORITY
State Drug Control Organisation
Drugs Controller/ Commissioner Drug Testing Laboratory
Deputy Drugs Controller Govt. Analyst
Drug Inspector Analyst
Supporting Staff Supporting Staff

13. Responsibilities and functions of SDCO
 Licensing of drug manufacturing and sales establishments.
 Licensing of drug testing laboratories.
 Approval of drug formulations for manufacture.
 Monitoring of quality of Drugs & Cosmetics, manufactured by
respective state units and those marketed in the state.
 Investigation and prosecution in respect of contravention of legal
provisions.
 Administrative actions.
 Pre and post licensing inspection.
 Recall of sub-standard drugs.

14. JOINT RESPONSIBILITIES OF CDSCO & SLAS
Vaccine &
Sera
Blood & its
Components LVPs
R-DNA
Products
Medical
Devices
Licensing of Specialized
products

15. CERTIFICATE OF PHARMACEUTICAL
PRODUCT (COPP)

16. The COPP certificate is given by the National Health Authorities upon
demand from the client, the specialists or the producer of item.
A COP is in the format recommended by the WHO.
It is the importing country who requires the COPP for the pharmaceutical
product and a special type of certificate which enables a given
pharmaceutical product to be registered and marketed in the exporting
country of interest and forms parts of the marketing authorization
application.
This is issued by the Inspectorate and the fabricator of the product having
GMP position and also the position of the pharmaceutical,
radiopharmaceutical, biological or veterinary product.
The approved information for different pharmaceutical forms and
strengths is varied so it is always issued for a single product.

17. AIM:
A COPP shows that the imported medication is of the fitting
standard of value, security and adequacy to permit it in their
market, having experienced thorough testing and assessment to
Regulatory Authorities in the trading nation and furthermore
exhibits that it follows the right rules and techniques of Good
manufacturing Practice (GMP), expanding the degree of value and
without a doubt wellbeing of the item.

18. SCOPE:
 It is needed when the product is intended for registration or its renewal
(licensing, authorization or prolongation) by the importing country, with
the scope that the product are distributed or commercialized in that
country.
 A certificate has been recommended so that it helps the undersized drug
regulatory authorities (DRA) or also without proper quality assurance
facilities in importing countries by WHO and also it can assess the
pharmaceutical products quality as per the requirements of importation or
registration.
INSPECTION:
The DRA gives a COPP only after conducting an inspection of the
manufacturing product.

19. TYPES OF COPP
1.WHO 1975 type COPP:
The WHO 1975 version is a certificate to be issued by exporting country
regulatory authority stating:
 The authorized product has to be placed on the market for its use in the
country also, the permit number and issue date or
 That the nonauthorized product has placed on the market for its use in the
country and also adds the reasons why it is needed;
 As recommended by WHO, the manufacturer of product conforms to GMP
requirements.
 Only within the country of origin the products to be sold or distributed or
 To be exported to manufacturing plant where the product is produced and
at suitable intervals subject to inspections.

20. 2. WHO 1988 type COPP
The competent authority of the exporting country should have:
 All labelling copies
 Product detailed information in the country of origin
3. WHO 1992 type COPP
This is intended for use by the competent authority of an importing
country in two situations:
 When the question arises related to importation and sale license and
 For license renew, extend, review or changes.

21. FORMAT:
This certificate conforms to the format recommended by WHO
• Certificate No.:
• Importing country (requesting) name:
• Exporting country (certifying) name:
1. Name and its dosage form:
1.1 API(s) and its amount per dose
1.2 Is the product placed for use in the exporting country or not?
1.3 If the product present on the market in the exporting country?
 If the answer is yes, continue with section and omit section 3.
 If the answer is no, omit section 2 and continue with section 3.

22. 2.1 Number of product license and date of issue:
2.2 Product license holder (name and address):
2.3 Status of product license holder:
2.3.1. For b and c categories, the name of product and address of
its manufacturer must be present:
2.4 If approval appended or not?
2.5 Is the officially approved product information complete and
readily available according to the license?
2.6 Applicant for certificate, if different from license holder (name
and address):

23. 3. Certificate applicant (name, address and required info);
3.1 Status of applicant:
3.2 For (b) and (c) categories, the name and address of the manufacturer
producing the dosage form is:
3.3 If the marketing authorization not required, not requested, under
consideration or refused?
3.4 Other additional information
3.5 If the periodic inspection of the manufacturing plant in which the
dosage form is produced or not/ not applicable?
If not or not applicable, proceed to question 5;4. Routine inspections
periodicity (years):

24. 4.1 Has the manufacture been inspected or not?
4.2 The operations and facilities conform to GMP recommendation or not?
5. The information submitted by the applicant satisfy the certifying authority
or not?
Explanation required if not authorized:
• certifying authority address:
• Fax:
• Telephone:
• Name of authorized person with signature:
• Stamp or date:

25. How to obtain COPP?
 To obtain a COPP, a request is made to the exporting country’s
health authority by the Marketing Authorization Holder (MAH).
 An authorized person issues the COPP and returns it to the MAH.
Also other documents required to obtain a COPP including an
application for Export Certificate form, evidence of a GMP
certificate (if applicable), Manufacturing License and the last
approved SmPC (Summary pf Product Characteristics).

26. Certificates May Be Issued
 Legally marketable drug in the country.
 Nonauthorized drugs for distribution in the country which are
legally exported
 For a foreign manufactured drug. Exportation for personal use
 Awareness is necessary for the drugs that are legal in some
countries may be illegal in other countries.
Importation for personal use
 Risky to health, such drugs are prevented from importation.
 Also Enforcement actions have been taken domestically.

27. Types of drugs for which COPPs may be issued
 Approved drug products
 Active pharmaceutical ingredients (API)
 Over the counter drug (OTC) products
 Unapproved drug products
 Homeopathic drugs

28. Who can Apply for COPP?
 A complete application for export certification must be
submitted by the company who exports the drug.
 The certification is intended for a drug which: meets the
applicable requirements of the Act or FDA 801(e) (1)
requirements.

29. Process to apply for a COPP
a) Submit Form no. 3613b – located on the FDA internet
www.fda.gov/downloads/AboutFDA/Reports Manuals Forms/ Forms/UCM052388
b) Requirements for COPP application:
 Applicant Contact information
 Trade name (the product’s brand name)
 Bulk substance Generic name
 Name of Applicant
 Status of product license holder
 Listing of manufacturing location on COPP
 Complete Manufacturing Facility Address
 Facility Registration Number
 Importing countries
 Authorization to release information
 Number of certificates requested
 Marketing status in the exporting country

30. Attachments to COPP
 Two sets of attachments required for one country (one set to attach to the
certificate package and one set for FDA files).
 Attachments must not be more than five pages per certificate.
 Applicant is responsible for consulting with the importing country to
determine the type of the information required.
Process Time
 Drugs in compliance are normally issued within 20 government working
days of receipt of complete and an accurate COPP application

31. Certificates may not be issued
 Returned- Missing information application with a letter identifying the missing
information.
 Rejected- Manufacturing facilities are not in compliance with good manufacturing
practices (GMPs).
 Denied- Drug products are not compliance as per regulation (e.g. misbranded drug)
Ribbons on COPPs
 Colored ribbons designate the type of COPP:
Red: Approved drug product, API, OTC marketed as per monograph, and export only drugs.
Blue: Unapproved drug product not marketed in the country.
Yellow: Drug manufactured with foreign manufacturing sites.

32. Expiration of COPP
 Certificate expires on 2 years from the notarization date or as noted.
 After expiry date, a new COPP application has to be submitted.
Benefits
 To grow business in foreign country, necessary to obtain the COPP certificates by
pharmaceutical companies.
Summary
 Know the requirements of the importing country prior to submitting an application
while obtaining COPP.
 Complete Application Form no. 3613b.
 Submission of required documentation.