CDSCO.pptx

Responsibilities and Functions of CDSCO

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 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: 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 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.