This includes the following contents: 1. Introduction 2. Procedure for Export of products 3. Technical Documentations MFR, BMR, COA, COPP 4. Drug Master File 5. Common Technical Document 6. Electronic Common Technical Documents 7. ASEAN Common Technical Document

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.

8. MFR Sample…..

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

10. BMR Sample ………….

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

12. COA Sample……………….

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

17. Common Technical Document

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