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Registration of Indian Drug
Product in Overseas Market
Presented BY
Keshav(810468)
Neeraj(810473)
Aman(810457)
Pardeep(810475)
Ankit (810461)
UnderSupervision of
(Dr.S.C.Arora)
Director/Principal
R.K.S.D.College of Pharmacy,
Kaithal(Haryana)
Batch2017-21
Contents
 Introduction
 Procedure for Export of products
 Technical Documentations
 Drug Master File
 Common Technical Document
 Electronic Common Technical Documents
 ASEAN Common Technical Document
Introduction
 Indian Pharmaceutical Market :
 Indian Pharmaceutical Market ~U S $ 2 0 B n
 The Indian pharmaceutical industry has acquired a noteworthy position in
the global pharmacy sector and has been achieving significant growth in
the recent years.
 India is among the top six global pharmaceutical producers in the world.
Presently there are 10,500 manufacturing units and over 3,000 pharmacy
companies in India, growing at an expectational rate.
 India has about 1,400 WHO GMP approved manufacturing units
 Structure of Indian Pharmaceutical Sectors :
 Indian Pharmaceutical sector can be divided into two major segments
namely , Active pharmaceutical Ingredients (API) or bulk drugs and
formulations.
 The API can be branded or generic and these ingredients will be a part
of formulations, which will be used to treat Acute or Chronic diseases.
Manufacturing by Indian pharmaceutical
players
Pharmaceutical
manufacturing
Bulk drug
Domestic
Generic contract
manufacturing
Export
Patent drug
contract
manufacturing of
intermediate
Generic contract
manufacturing
Formulation
Export
Domestic
Generic Retail
contract
manufacturing
PROCEDURE FOR EXPORT OF
PHARMACEUTICAL PRODUCTS
1. Apply for IEC
number
2. Get the means
costumers contact the
countries interested in
importing the drug
3. Register the drug
product in the country
where you are going to
export.
4. Get the DCGI
approval for exporting.
5. Finalize the
shipping method.
6. Receive the
purchase order from
the country which is
importing and send
invoice with Complete
product details
7. Sign the contract
with the agency of the
importing country.
8. Pre-shipment
inspection.
9. Export of the
products.
Technical Documentations
Master
Formula
Record (MFR).
Batch
Manufacturing
Record (BMR).
Certificate of
Analysis
(COA).
Certificate of
Pharmaceutical
Product
(COPP).
Master Formula Record
 Master formula record is a master document for any
pharmaceutical .
 MFR contains all information about the manufacturing
process for the product .
 MFR is prepared by the research and development
team of the company
 MFR is used as reference standard for preparing batch
manufacturing record by manufacturing units.
 MFR is also called master manufacturing record,
master production record.
MFR Sample…..
Batch Manufacturing Record
Definition:-
The batch Manufacturing Record is the necessary
quality and GMP documentation for tracing the complete
cycle of manufacturing batch.
Maintenance of BMR:-
1. Primary maintainers : QA Officers/QC officers/
production officers.
1. Secondary maintainers : QA Manager/QC Manager /
production Managers
BMR Sample ………….
Certificate of Analysis
1. COA will be issued to prove the purity of
the product.
2. The Laboratory where the testing will be
done should be approved by the WHO and
should comply with the Good Laboratory
Practices.
3. COA will be issued to each batch to show
that the product is uniform from batch to
batch
COA Sample……………….
Certificate of Pharmaceutical
Product
1. COPP is a certificate issued in the format of WHO by the
National Health Authorities.
2. COPP will be issued by the Exporting country upon
request from the applicant.
3. It will be issued for each product for each country.
4. Same COPP cannot be used for all the markets.
Ribbons on COPPs:
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.
Drug Master File
• Drug Master File (DMF) is a confidential
document for Active Pharmaceutical Ingredient
submitted to the regulatory body for the approval
process.
• In fact there is no regulation to file a DMF.
• DMF’s are neither approved nor disapproved.
It has divided into 2 parts:
Open part (Applicant’s part)
Closed Part (Restricted part)
DMF is divided into 5 types:
Type I: Plant information
Type II: Drug substance, drug products, intermediates and materials used in manufacturing.
Type III: Packaging materials.
Type IV: Excipients or additives.
Type V: FDA accepted reference information
Common Technical Document
Common Technical Document is an essential document to
be submitted to regulatory body as a supportive list of
leaflets attached with the registration applications for
pharmaceuticals to get market authorization.
There are mainly five module in CTD:
Module Contents
Module 1 Administrative and Prescribing Information
Module 2 Common Technical Document Summaries (Quality
Overall summary)
Module 3 Quality Data
Module 4 Non-clinical Study Report
Module 5 Clinical Study Report
Common Technical Document
Electronic Common Technical
Document
eCTD is electronic Common Technical Document, an
electronic format where the information and
document is submitted to regulatory body
electronically by using a software.
Common Formats of eCTD:
1. Narrative: Portable Document Format (PDF)
[Calibri 12]
2. Structure: Extensible Mark-up Language (XML)
3. Graphic: Use PDF, whenever PDF is not
supporting, use Joint Photographic Experts
Group (JPEG), Portable Network Graphics
(PNG), Scalable Vector Graphics (SVG)
ASEAN Common Technical Document
ASEAN (Association of South East Asian Nations)
ASEAN Common Technical Document (ACTD) is a
structured document for the registration of
pharmaceuticals in ASEAN countries
Laos Vietnam Singapore Thailand Indonesia
And other
ASEAN
countries
Part 1
Table of Contents, Administrative Data and
Product Information
Part 2 Quality Document
Part 3 Non-clinical Document
Part 4 Clinical Document
Organisation of ACTD
Registration of Indian Drug Product in Overseas Market.pptx
Registration of Indian Drug Product in Overseas Market.pptx

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Registration of Indian Drug Product in Overseas Market.pptx

  • 1. Registration of Indian Drug Product in Overseas Market Presented BY Keshav(810468) Neeraj(810473) Aman(810457) Pardeep(810475) Ankit (810461) UnderSupervision of (Dr.S.C.Arora) Director/Principal R.K.S.D.College of Pharmacy, Kaithal(Haryana) Batch2017-21
  • 2. Contents  Introduction  Procedure for Export of products  Technical Documentations  Drug Master File  Common Technical Document  Electronic Common Technical Documents  ASEAN Common Technical Document
  • 3. Introduction  Indian Pharmaceutical Market :  Indian Pharmaceutical Market ~U S $ 2 0 B n  The Indian pharmaceutical industry has acquired a noteworthy position in the global pharmacy sector and has been achieving significant growth in the recent years.  India is among the top six global pharmaceutical producers in the world. Presently there are 10,500 manufacturing units and over 3,000 pharmacy companies in India, growing at an expectational rate.  India has about 1,400 WHO GMP approved manufacturing units  Structure of Indian Pharmaceutical Sectors :  Indian Pharmaceutical sector can be divided into two major segments namely , Active pharmaceutical Ingredients (API) or bulk drugs and formulations.  The API can be branded or generic and these ingredients will be a part of formulations, which will be used to treat Acute or Chronic diseases.
  • 4. Manufacturing by Indian pharmaceutical players Pharmaceutical manufacturing Bulk drug Domestic Generic contract manufacturing Export Patent drug contract manufacturing of intermediate Generic contract manufacturing Formulation Export Domestic Generic Retail contract manufacturing
  • 5. PROCEDURE FOR EXPORT OF PHARMACEUTICAL PRODUCTS 1. Apply for IEC number 2. Get the means costumers contact the countries interested in importing the drug 3. Register the drug product in the country where you are going to export. 4. Get the DCGI approval for exporting. 5. Finalize the shipping method. 6. Receive the purchase order from the country which is importing and send invoice with Complete product details 7. Sign the contract with the agency of the importing country. 8. Pre-shipment inspection. 9. Export of the products.
  • 6. Technical Documentations Master Formula Record (MFR). Batch Manufacturing Record (BMR). Certificate of Analysis (COA). Certificate of Pharmaceutical Product (COPP).
  • 7. Master Formula Record  Master formula record is a master document for any pharmaceutical .  MFR contains all information about the manufacturing process for the product .  MFR is prepared by the research and development team of the company  MFR is used as reference standard for preparing batch manufacturing record by manufacturing units.  MFR is also called master manufacturing record, master production record.
  • 9. Batch Manufacturing Record Definition:- The batch Manufacturing Record is the necessary quality and GMP documentation for tracing the complete cycle of manufacturing batch. Maintenance of BMR:- 1. Primary maintainers : QA Officers/QC officers/ production officers. 1. Secondary maintainers : QA Manager/QC Manager / production Managers
  • 11. Certificate of Analysis 1. COA will be issued to prove the purity of the product. 2. The Laboratory where the testing will be done should be approved by the WHO and should comply with the Good Laboratory Practices. 3. COA will be issued to each batch to show that the product is uniform from batch to batch
  • 13. Certificate of Pharmaceutical Product 1. COPP is a certificate issued in the format of WHO by the National Health Authorities. 2. COPP will be issued by the Exporting country upon request from the applicant. 3. It will be issued for each product for each country. 4. Same COPP cannot be used for all the markets. Ribbons on COPPs: 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.
  • 14. Drug Master File • Drug Master File (DMF) is a confidential document for Active Pharmaceutical Ingredient submitted to the regulatory body for the approval process. • In fact there is no regulation to file a DMF. • DMF’s are neither approved nor disapproved. It has divided into 2 parts: Open part (Applicant’s part) Closed Part (Restricted part)
  • 15. DMF is divided into 5 types: Type I: Plant information Type II: Drug substance, drug products, intermediates and materials used in manufacturing. Type III: Packaging materials. Type IV: Excipients or additives. Type V: FDA accepted reference information
  • 16. Common Technical Document Common Technical Document is an essential document to be submitted to regulatory body as a supportive list of leaflets attached with the registration applications for pharmaceuticals to get market authorization. There are mainly five module in CTD: Module Contents Module 1 Administrative and Prescribing Information Module 2 Common Technical Document Summaries (Quality Overall summary) Module 3 Quality Data Module 4 Non-clinical Study Report Module 5 Clinical Study Report
  • 18. Electronic Common Technical Document eCTD is electronic Common Technical Document, an electronic format where the information and document is submitted to regulatory body electronically by using a software. Common Formats of eCTD: 1. Narrative: Portable Document Format (PDF) [Calibri 12] 2. Structure: Extensible Mark-up Language (XML) 3. Graphic: Use PDF, whenever PDF is not supporting, use Joint Photographic Experts Group (JPEG), Portable Network Graphics (PNG), Scalable Vector Graphics (SVG)
  • 19. ASEAN Common Technical Document ASEAN (Association of South East Asian Nations) ASEAN Common Technical Document (ACTD) is a structured document for the registration of pharmaceuticals in ASEAN countries Laos Vietnam Singapore Thailand Indonesia And other ASEAN countries Part 1 Table of Contents, Administrative Data and Product Information Part 2 Quality Document Part 3 Non-clinical Document Part 4 Clinical Document Organisation of ACTD