PROMOTION COUNCIL

(Set up by Ministry of Commerce, Govt. of India)

H. O.: 101, Aditya Trade Centre, Park Inn Hotel Complex, Ameerpet, Hyderabad-500 038, Ph.: 040-23735462/66 Fax : 040-23735464 Email : info@pharmexcil.com Website : pharmexcil.com

Indian Gateway to Pharma Global Village

REPORT ON TUNISIAN VISITFrom PHARMEXCIL SIDE

As a part of Survey Team

10-16 April 2006, Tunis.

Contents

Sr. No. Subject Page No.

1. Introduction 3

2. Objective 4

3. India’s Export to Tunisia 5

4. Tunisian Drug Market 6-7

5. Tunisian Investment Policy 8-10

6. Tunisian Registration Procedure 11-14

7. Opportunities for Indian Pharma Companies 15

8. Potential for JV / Collaborations 16

10. Conclusion 17

11. Annexure 1 18

12. Annexure 2 19

13. Annexure 3 20

14. Annexure 4 21

15. Annexure 5 22

12.

Introduction

As a follow-up of the 3rd JWG meeting of Indo-Tunisia Joint Working Group held in New Delhi 30.11.2005, a survey team from India is deputed to visit Tunisia to assess the possibilities for setting up of Joint Ventures in Tunisia in the area of Pharmaceuticals and Health Tourism. The Survey Team comprised of the following :

1. Mr. Paresh Johri, Deputy Secretary, Department of Chemicals and Petrochemicals, Ministry of Chemicals and Fertilizers, Government of India, New Delhi, India.

2. Ms. Meenakshi Munshi, Principal Scientific Officer, Department of Biotechnology, Ministry of Science of Technology, Government of India.

3. Dr. Pramil Tiwari, Associate Professor, National Institute of Pharmaceutical Education and Research, Ministry of Chemicals and Fertilizers, Government of India.

4. Mr. G K Raman, Regional Director, Pharmaceutical Export Promotion Council (PHARMEXCIL), A Set Up by Ministry of Commerce and Industry, Government of India.

5. Mr. K Y Vishwanathan, Area Manager, Ranbaxy Laboratories Limited, Morocco.

Objective of the visit  

To identify specific areas for cooperation in the form of Joint Ventures in Tunisia, Technology transfers, Sourcing of APIs/Formulations from India.

To learn about the policies of Government of Tunisia in o facilitating JVs with Indian companies. o the Incentives/concessions offered by Tunisia for joint venture

companies. o the Legal framework for working out joint ventures.

Whether there is any single agency which will assist Indian companies in setting up Joint Ventures.

Any financial assistance that can be provided under any existing scheme of Government of Tunisia.

Regulatory system for Pharmaceuticals in Tunisia.

Drug Purchase policy of Tunisia from Joint Venture companies.

Status of FTA with Europe/ Other African countries- Can JV companies market to these areas without any difficulties.

List of Tunisian companies which would be interested in JVs/ Collaborations with Indian companies along with their areas of interest.

India’s Export to Tunisia

INDIA RANKS 28TH FOR THE EXPORT OF PHARMACEUTICAL PRODUCTS WITH THE TOTAL EXPORT VALUE OF USD 0.077 Million With the % share of 0.05% Penicillins or streptomycins and their derivatives, formulated in bulk account is

the largest exorted product with the value of 0.06 Million US$ which accounts 77.92%

Tunisian Drug Market

Total Tunisian Drug Market : US$ 40 Million Dollars

Total Importation in KG : 2680

Total Importation in Value : US$ 29.5 Million Dollars

Total Local Pharma Companies : 18 Nos.

Most Frequent Cause of Death

Disease Male Female

Circulatory System Disease 27% 31%Cancers 18% 14%Respiratory System Disease 10.5% 7.8%Prenatal Period Pathologies 7.8% 8.7%Metobolic and Endocrine Disease 7.1% 7.2%

Sampling of Drug Prices in TunisiaDrugs Tunisia

Ciprofloxacin HCL 500 mg 10’a tabs Times Costlier

26.35

41

Diclofenac Sodium50 mg 10’s tabsTimes Costlier

1.35

18

Ranitidine150 mg 10’s tabsTimes Costlier

5.48

39

Drug Dosage Tunisian Price*

• Lipitor 10 mg 2.41 • Omezprazole 20 3.53 • Plavix 75 4.25 • Zantac 150 2.10

• Zocor 20 4.25 • HEP B 4.50 • R Human Insulin 100 IU 2.50 • Rotavirus Vaccine 35.00

Tunisian Investment Policy

Principal Assets of Tunisia

Proximity of Europe and very short delivery periods. Access of Frankness from the rights and taxations of the industrial products of

the European market. Presence of confirmed technical skills and high managerial qualifications Competitive production costs advantageous tax and financial incentives Good infrastructure of transport and communication in course of modernization

and thickening Domestic market in full growth and presence of multinational leaders in sector

of production

The incentive for Investment

The accession of Tunisia to several International Convention and agreements is likely to offer to the foreign investors reliable guarantees relative to their projects in Tunisia :

Agreement of protection of the investments and non-double –imposition with majority of OECD countries

Agreement of the UNCTAD relating to protection of the licences and trade marks

Tunisia is member of OMPI and the CIRDI

The foreign investors can hold upto 100% of the capital in manufacturing industries without authorization. Current code of incentive to the investments devotes freedom to invest in the majority of the sectors and thus reinforces the opening of the Tunisian economy on outside.

Among the advantages granted by the code the total exemption of the income tax during the first ten years for the incomes for the incomes originating from the export and projects of the regional developments.

The total frankness from the rights and taxes for the equipment imports equipments, raw materials and semi-manufacturers for the completely exporting companies. Premiums with the investment are granted for the environmental protection (20% of the cost of the installations) the regional development : 15% or 25% of the project depending on the site.

The assumption of the responsibility of the social security contributions by the state for a five years period in the two following cases

o Employment of the graduates of the higher educationo Projects established in the zones of encouragement to the regional

development. In this last case, the state also undertakes the expenses

of the infrastructure. With the end of the year 2005 2139 foreign companies or with mixed capital operational in Tunisia.

Tunisia is classified among overall liberal economies according to the American Foundation: - the investment is free for the nationals and foreigners in many branches o the industry – 96% of the production are subjected to international competition – 87% of the production prices are governed by the mechanisms of the market. The account of the companies are presented obligatorily according to a standardized countable system, inspired by that into forces in the OCDE countries.

Taxations :

The Tunisian tax systems was the subject of an important recasting . It include essentially :

The single tax on the incomes of the physical people and the benefit of the companies. The corporation tax is 35% in general and 10% for the agricultural companies, the craft industry and the small trades

The Value added tax : The directing rate is 18%, two undervalued rated of 6% for the sensitive products and 10% for certain goods of equipment and services raised rates of 29% for a limited list of products of luxury.

Custom duties of a maximum of 43%. A tarrif program of dismantling has been engaged since 1996 on the level of the industrial products coming from the European and certain countries of the south of the Mediterranean for the purpose of founding a total zone of free trade in the year 2008.

Industrial Legislation :

The industrial relationships are controlled by the Fair labor standards act and sectoral collective agreements. The amendments of the fair labour standards act adopted in 1994 and 1996 allow :

The recourse to the employment contract with determined duration even for the permanent posts without limitation and this is up to four years.

The adaptation of the schedules and the operating speed ranges to the needs of the company

The fixation of a part of remuneration on the basis if productivity The dismissal or the setting in layoff for economic or technological reasons. The leveling off the damages for the abusive dismissals The unification of the structures of dialogue in only one structure called

advisory commission of company.

MODE OF EXCHANGE

The Tunisian dinar is convertible for the current operations since 1994 :

Transfers relating to the incomes of the capital (benefit, remunerations of the founder’s share, dividends, percentage and attendance fees, interest to the title of the loans)

Transfers relating to the commercial deals and related operations Transfers relating to the operations related to the production

Are also free, the transfers in virtue of the real product neat of cession or liquidation of the invested capital by means of currencies imports, including the increase. In addition the foreign exchange market created on 1994, ensured in 1999 approximately 80% of the operations of purchase and sale of cash currencies and 100% of the long term operations.

MONEY MARKET

The money market was the subject of an important reform to reach the international standards. This reform is articulated around the following axes.

The privatization of the movable Stock Market (BVM), entirely held by the intermediaries out of the stock exchange.

The institution of the council of the money market as an autonomous authority in charge to regulating the sector and controlling the operations in order to protect the investors

The institution of guarantee funds of the money market managed by the BVM in order to cover the intermediaries out of stock exchange against the risks of counterpart.

The installations of an electronic system of quotation. Currently 44 companies are registered to the share of the sock exchange.

The foreign investors hold 20.7% of the stock exchange capitalization. Tunis stock Exchange presents an atteactive PER : 10 in 1998 and 13 in 1999.

Registration Details

File for an Inspection’s site of a foreign laboratory

1. GENERAL INFORMATION

1.1 A Copy of the Status of the Firm

1.2 Presentation of the Firm

Brief information on the Firm (CA, functioning ………)

1.3 Certification

Manufacturing licence delivered by competent national authorities

WHO – GMP CERTIFICATION delivered by the proper authorities of the country of origin and/or a report of inspection emanating from proper authorities of the country of origin dating less than two years.

1.4 Description of the site

Location – geographic situation

Size of the site, type and age of buildings

Immediate environment

1.5 Name (Coordinates)

Address

Telephone

Fax

E.Mail Address

Website

Contact person

1.6 Manufacturing activities

Pharmaceutical manufacturing activities as licenced by the national authority.

Other activities.1.7 Type of products manufactured on the site

Sterile products (Liquid dosage, semi-solid dosage, solid dosage forms)

Non-sterile products (Liquid dosage forms, semi-solid dosage forms, solid dosage forms (tablets, capsules, suppositories, pessaries – powders - granules)

Biological products (Vaccines, Blood products or others),

Specifically toxic and hazardous substances (Pencillines, Cephalosporins, Hormones, Cytostatics and others)

Drugs for clinical trials.

Others (e.g. veterinary products, cosmetics, etc.)

1.8 List of product fabricated with indication of licensed pharmaceutical products (marketing authorization) obtained in the various countries.

1.9 Short description of the quality management system.

Quality Policy,

Responsibility of the Quality Assurance function,

Elements of the QA System (organizational structure, responsibilities, procedures, processes)

Audit programmes

Validation – qualification

Complaints

Product recall

2. PERSONNEL

Organisation chart

Qualifications, experience and responsibilities of key personnel

Number of employees engaged in the quality assurance, production, quality control, storage, distribution and Technical & Engineering Support Services.

Health requirements for personnel engaged in production.

Personal hygiene requirements, including clothing.

3. PREMISE AND EQUIPMENT

3.1 Site Plan

3.2 Plan of manufacturing areas including activities

3.3 Nature of construction and finishes

3.4 Flow of materials, personnel, product

3.5 Brief description of ventilation systems (schematic drawings of the systems) with details for classified room and area (pressure differentials between adjoining areas of different classifications, air change rate, temperature, humidity…)

3.6 Brief description of water systems (Schematic drawings of the systems) with indication about :

Capacity of the system (maximum quantity produced per hour)

Construction materials of the vessels and pipework.

Specification of any filters in the system must be given.

Specification of the water produced.

Sampling points and frequency of testing.

Procedure and frequency for sanitation.

Maintenance

3.7 List of major equipment used in production (location with the reference of plans).

3.8 List of major equipment used in quality control laboratory

4. DOCUMENTATION

Description of the documentation system.

List of standard operating procedures (principals)

5. PRODUCTION

Description of production operations (processes with important parameters)

6. QUALITY CONTROL

Quality control system.

Activities of the quality control department

7. CONTRACT MANUFACTURE AND ANALYSIS

Nature of sub-contracted operations.

Describe briefly the technical aspects of the contract between the contract giver and the contract accepter.

Opportunties 

Bulk drug/ raw material supplies from India. Collaboration from Indian companies for formulations. Product enhancement for Tunisian Pharma through product Dossiers. Technical expertise enhancement for Tunisian Pharma Industry. Supply of equipments for Pharma Production. Training of Tunisian drug professionals in Indian Pharma Industry. Identifying Vaccine producing companies to participate in tenders. Oncology/cardiovascular drugs not covered by patent regime

As per enclosed Excel Sheet, Local companies are very keen to work with Indian Companies.

 

Potential of Collaboration and Joint Venture The opportunities for Joint Venture and Collaboration were discussed in detail between the members of the Survey team and the Government / Pharmaceutical industry of Tunisia and it has been agreed upon:

1. On behalf of the Indian Pharmaceutical Industry, the PHARMEXCIL has expressed its keen interest in providing quality Pharmaceutical products such as Bulk Drugs, API, Oncology Products etc. through its member companies to the Tunisia.

2. Indian Pharma Industry will like to assist the Local Industry to increase the number of items produced according to market demand (public and private) in Tunisia. Further the member companies of PHARMEXCIL shall provide the Technical know-how and collaborate with Tunisian Pharma Companies to produce these items.

3. Both sides agreed that is very important that technical teams form the Tunisian Drug Regulatory authorities visits the pharmaceutical factories and companies specialized in formulation and raw materials to evaluate the pharmaceutical industries in India. The PHARMEXCIL further offered an official invitation to the team of Tunisian regulatory authorities to visit India in order to evaluate and see the pharmaceutical factories and companies.

4. The cooperation in the field of technical training in pharmaceutical manufacturing both for formulation and Bulk Drug.

5. The PHARMEXCIL seeks cooperation from Tunisian Ministry of Public Health in identifying the mutually agreed companies from India, organizing their plant visits, and if found satisfactory by Tunisian regulatory authorities then These companies should get the benefit of Fast track registration.

6. The PHARMEXCIL desired that such mutually agreed Pharmaceutical companies shall be allowed to participate in the tendering process and if shortlisted then their plant visits shall be organized on priority basis.

7. Sourcing of APIs from India – Quality drugs at cost-effective rates 8. Short term training of personnel of Tunisia at NIPER, India. 9. Setting up of Joint ventures in Tunisia for Tunisian market as well as African/EU

markets. 10.Manufacture of medical devices & hospital equipments. 11.Cooperation in vaccine production and supply

Conclusion

India can climb from present 28th position to single digit position. Tunisia can outsource international quality medicines from India at

almost half the prices Tunisia can access large trained manpower for quality health services India can provide world class Healthcare services

The survey team has been able to identify specific areas for JV/Collaboration which will pave way for further co-operation.

PHARMEXCIL Government and Industry would welcome partnerships with Tunisia to compliment each other in providing access to affordable, quality medicines and Healthcare

Annexure 1

List of Local Pharma Companies based out of Tunisia and their interest with Indian Pharma Industry

Annexure II

Photographs of Indian team and Tunisian Team

Annexure III

Photograph Galary of India – Tunisian Delegation

Annexure IV

Presentation made by Tunisian Side

Annexure V

Presentation made by Indian Survey Team Leader

Mr. Paresh JohariDeputy Secretary (Pharmaceuticals)

Department of Chemical and PetrochemcialsGovernment of India