Pharma International Business Asia and Franco Africa specific with modus operandi, regulatory requirements, logistics operations, pricing formula, terms of agreements and the inco terms.

1. International Business
Presentation
By Raviraj Kadam

2. Profile
• I have over 9 years experience into Pharmaceutical Industry
(International & Domestic).
• Responsible for the MOH audit and GMP clearance/renewal.
• Looking after the registration and business development of Products
and third party products in SEA and Francophone countries.
• Also responsible for the finalizing the business partner and
implementation of marketing strategies in respective countries with
proper agreement.
• To work in tandem with other departments (e.g Production, planning,
QC, QA, logistic partner (handling)) to ensure quality of products.
• Finalizing of the logistic partner for transportation of goods to the
mutually agreed location.

3. Acheivements
Country Achievement
Philippines CPRs of Seven new products.
Incremental business of $ 267,000 for the newly registered products over past two years.
Finalized four new business partner in Philippines for the products which are already registered and newly
registered products (with 4 importer).
Initiated the Philippines GMP renewal process and regularly following it up.
Generated new business of Remdesvir inj ($100,000) from New importer of Philippines.
In finalization of registered office in Philippines with takeover of existing registered company of Philippines.
Myanmar  Registered 4 new products.
 Incremental business of $ 49,000 over past two years with the existing products.
 Finalized new registration agency for our third party products and initiated the registration of 15 new
products.
 Participated and won the army tender for our products worth USD 1,20,000.
Cambodia  Renewal of GMP and products in Cambodia.
 Approached 2 new importers in Cambodia for our products.

4. Acheivements ctd..
Country Achievement
Vietnam  Initiated the registration and provided the documents of 4 respules.
 Regularly following up with registration agency and DAV for the registration.
Malaysia  Finalized registration agency and initiated the registration of new products with NPRA.
 Provided all the necessary documents required for registration of these products and regularly
following up for any queries pertaining for registration.
 Finalized terms of commercial agreement with importer.
Senegal  Initiated the registration of third party products and online submission of the dossiers with
DPM pending of 19 new products in Senegal from two local manufacturers.
 Participated in MOH tender and compiled documents for the same.
 Online submitted the dossiers of 4 new products in Ophthalmology.
ROW countries  Contacted and in final talks with Importer, Ivory Coast for Mktg authorization of registered
products.
 Field work in Uganda, Cameroon and Vietnam to understand the market first hand.
 Generated new business from Iraq & in talks with Yemen parties for our line of products.
 Approached new parties in Latam countries for our products.
 Triggered the audit of PIC/s Ukraine and going to submit the compliance or CAPA report.

5. SEA Business Profile
SEA Countries Exports from India
(Apr 20-Jan 21) INR
Products registered Products under registration Our exports
Myanmar 1620 cr 22 products Party 1 22 products,
Party 2- 18 products,
Party 3- 4 products
1.25 cr
Philippines 1801 cr 16 products 32 products 3.5 cr
Cambodia 331 cr 16 products 2 products 30 Lakhs
Vietnam 916 cr N.A 4 products In talks with importer
Malaysia 483 cr N.A 3 products Finalized Clauses of
commercial
agreement
Thailand 972 cr N.A 1 product N.A
Indonesia 509 cr N.A N.A N.A
Laos 32.6 cr N.A N.A N.A

6. Approvals
• US FDA – USA, Canada
• EU GMP – European Countries
• PIC/s – European Countries, Most of the Asian countries, LATAM
countries
• GCC (Gulf Countries Convention)
• Individual Countries approval
TGA Australia
AVISA Brazil
MFDS, Republic of Korea
MHLW/PMDA, Japan
NPRA, Malaysia
• WHO GMP (applicable for many countries)

7. Regulatory Requirements
SEA Countries Procedure
Myanmar
(Time line- 2-
2.5 years)
BN Clearance (LOA+FPS) Sample permit + Complete dossier (DMF in ACTD format, PP,
COPP, MFL attached, Stability Study, Artwork, Notarized GMP) Lab test Preview
Philippines
(Time line
1year-
1.8years)
GMP clearance (PFDA audit) BN application (complete dossier, COPP, PP, DMF in ACTD
format, Stability study (18-24 months, commercial artwork, samples (usually 6 units)
Evaluation of dossiers and samples Query response (if any) PCPR release
Cambodia
(Time line 6-8
months)
Attested (by Cambodia embassy in India WHO GMP clearance format containing (turnover of
the company, various departments and manpower with their respective positions, Products
line of the company) Dossier submission (ACTD format, PP, COPP, samples)
Registration certificate
Vietnam
(Time line 1.5
years-2 years)
GMP application to DAV for plant inspection Product details and understand the
regulatory requirements applicable for the product Application dossier submission (all
documents required are notarized and legalized by Vietnam embassy, declaration for raw
material, list of GMP inspections at home or other countries, list of drugs, procedure for
release, Product quality review) Evaluation of application dossier Respond to queries
and obtain the product registration certificate/ marketing authorization.

8. Modus Operandi of business
Ethical Promotion- We are looking forward of formation of sales team with
marketing support, promotion to health care professionals. Countries like
Vietnam and Philippines.
Distributor/ Importer- We works under this module in most of the
countries by appointing distributor for our registered brands and
supporting them with marketing inputs.
Third Party/Contract Manufacturing- We do manufacture the product for
the third party in domestic as well as exports.
Tender- We participates into the Tender through distributor.
Loan Licensing- We do loan licensing for many products in domestic as well
as exports.

9. Factors we consider while finalizing the
business Operation
• Ethical Promotion/ Direct promotion (future planning)
1. Size of the market
2. Product mix
3. Competition
4. Sales team strength
5. Price finalization through reverse calculation
6. Profitability
• Distributor/Importer (B2B model we follow)
1. Domain Expertise
2. Sales force
3. Experience and relationship with customers
4. Market Capitalization/ share
5. Annual turnover/ Financial status
6. Payment terms (Credit, LC, DA)

10. • Third Party Manufacturing (Contract manufacturing we do)
1. Product offerings
2. Quantity and price
3. Timeline for manufacturing
4. Markets and the authorization from the respective Health ministry.
5. Profitability
• Tender Participation (We participate in tender)
1. Documents required
2. Finalization of distributor
3. Quantity and price
4. Timeline for manufacturing
• Loan Licensing
1. Projection
2. Price
3. Place
4. Regulatory and documentary requirements.

11. Distribution Channel
• The different medicines require various environmental conditions for
their storage. In Asian countries Zone IV b storage condition is
applicable.

12. Our Pricing formula
Formula= Manufacturing Cost + Packaging/presentation Cost + Profit Margin +
Logistics Charges + Importer/distributor Margin + other expenses
Content Formula
Manufacturing cost Raw material cost + Converting charges
Packaging/presentation Cost Cylinder charges + Color charges + Packing material
cost+ Packaging cost
Profit Margin (Mfg discretion) Demand+ Market share+ Approvals + Inco terms
Logistics charges Container charges + Custom Clearance Charges +
Handling Charges + BL Charges + AIFTA COO charges+
Transportation charges (railing and ocean freight) +
Other charges (if any)
Importer/distributor Margin Domain expert + Manpower + Market Penetration +
Marketing expenses + Storage charges
Other Expenses Importation charges, duty paid by importer for
Custom clearance at receivers port

13. Terms of Agreement
• Type of Agreement – Export agreement, Trade agreement, Bi party, Tri party, Four
party, Tender specific.
Clauses
Address
Exclusivity/Non exclusivity clause
Quality standard commitment
Product recall
Price of product
Mode of Payment (Advance, Credit, LC)
Terms and termination of agreement.
Indemnity (protection against damage or loss)
Amendments
Force majeure
Arbitration

14. Logistics Operation
• Documents required while shipment
 Commercial Invoice (CI) with consignee and notify party details
 Packing List (PL) with dimensions of shipper.
 Bill of Lading (BL)
 AIFTA COO (e.g. Philippines)
 Certificate of Analysis (COA)
 Insurance
• Process of supply chain (Sea).
Goods ready at ware house Finalizing the logistic partner Dispatch Schedule to FGS
Numbering & labeling (barcoding) of Shippers/boxes Booking of container & Generation SB number
Loading of container at ware house and sealing Unloading at ICD (eg. Tughlakabad/TKD)
Reloading & transportation to port of discharge (eg. Mudra/JNPT) Sailing to the port of destination.

15. Incoterms 2010
 EXW – Ex- Works or Ex- Warehouse
FOB- Free On Board
CIF- Cost, Insurance & Freight
FCA – Free Carrier
CFR- Cost & Freight
CPT- Carriage Paid to
CIP- Carriage and Insurance paid to
DAP- Delivered at place
We Majorly follows CIF and FOB for exports and in domestic transport EXW.

16. Thank You