Dominican Republic Pharma Market

Dominican Republic

The Dominican Republic is considered as the jewel of the Caribbean. Dominican Republic is a beautiful amalgamation of Rainforests, Savannah and highlands offering the best of all these worlds to tourist who flock there for the beaches and exceptional golf courses.

Population

Approx 10.8 million

National Capital?

Santo Domingo

Official Language

Spanish

Life Expectancy

74 Years

Currency

Dominican Peso

1000 Dominican Peso is equivalent to USD 17.73

Major Cities

Santo Domingo

Santiago de los Caballeros.

Puerta Plata.

Sosua.

Cabarete10.8 million

Major Ports?

10 major ports in the Dominican Republic but the Port of Caucedo is the Largest in terms of trade volume.?

Location

The country is neighbors with Haiti which lays to the west side of the Island of Hipsaniola which both countries share. The DR is inhabited mostly by people of mixed European and African origins

Economy

Dominican Republic is the 8th largest economy within Latin America. The Dominican Republic was traditionally an exporter of primary products such as mining products, but the economy has changed now and medical devices are now the main export category.

GDP growth rate - 5.86%

Healthcare spending around 6% of GDP

Through its free trade zones, Dominican Republic shows continuous growth in the exports of medical equipment & pharmaceuticals.

Pharma Market Value:

Value close to USD 1Bn

Pharmaceuticals imported about 35% & 65% is the contribution of local pharma sector. Local pharmaceutical sector in a thriving growth that leads it to supply 65% of the national market and 25% of drugs in Central America and the Caribbean.

Indian pharma exports to Dominican Republic USD 54 Mn. ???

Pharma Market Type

Dominican pharma market is a core local, generic & price-sensitive market.

It is known as manufacturing hub for medical device. A free trade agreement with the US & Europe making Dominican Republic an attractive manufacturing destination for Medical Devices. Puerto Rico, an island-nation is also known as the Island of Medical Device.

The Dominican Pharma market growth is almost stagnant and is contracting; the chances of growing inside are now difficult.?Need lot of investment to run the operation and it is expensive. The factory had surplus production capacity.

Healthcare system

The Dominican Republic has become a destination for preventive medicine, orthopedics, cosmetic surgical procedures, weight loss surgery, cardiology, organ transplant, oncology, eye surgery, and dental procedures.

The private sector provides healthcare to the upper-economic segment of the population under a government-controlled system.

The health system also known as Seguro Familiar de Salud has two mechanisms:

1.???Contributive Insurance Plan- It is for formal workers, their families and for retirees

2.???Subsidized Insurance Plan - For the rest of the population.

75% population is covered by Insurance.

Ministry of Public Health

The Ministry of Public Health and Social Assistance of the Dominican Republic, also known by its acronym as?MISPAS.

FDA Name

The General Directorate of Drugs, Food and Sanitary Products or “DIGEMAPS”

Product Registration Cost

Dominican Republic requires local representation in the form of an agent or distributor.

For the processing of a?New Registration:

·??????Drugs: USD 740

·??????Cosmetic, personal hygiene and household merchandise: USD 159

·??????Sanitary merchandise: USD 318

·??????Groceries and beverages: USD 71

For the processing of a?Renewal:

·??????Drugs: USD 740

·??????Cosmetic, personal hygiene and household merchandise: USD 159

·??????Sanitary merchandise: USD 317

·??????Groceries and beverages: USD 71

Validity

The authorization must be renewed every five (5)

Type of Dossier

CTD

Stability- IVa; 30°C/65% RH

The climate condition is high temperature & special protection is needed to keep the product stable.?Many pharma products which are hydroscopic or photosensitive in nature may altered by light and moisture and must be properly preserved to ensure their quality.

Sample Requirement

Three (3) original samples of the product, in the same presentation (package or container) in which it will be sold in the market. For products whose label is not in the Spanish language, an adhesive sticker can be used on the original label, containing all of the required information.

Product Registration Time

Approximately 4 months, local laboratories with good manufacturing practices and multinational importers were given fast registrations in around 3 months.

Plant Inspection

No

Medical Devices

Classification system:

Medical Devices: Class I/IIa/IIb/III

IVD Devices: Class I/IIa/IIb/III

Time Frame of Medical Devices Regiatration:

Medical Devices/IVDs (Class I/IIa/IIb/III): 180 – 240 working days or 6 – 12 months

Local Fees (New Application):

Medical Devices/IVDs (Class I/IIa/IIb/III) – USD190

License Validity:?

Five years

Public Sector Health Institutions/Tender Body:

All Public Sector Health Institutions procurement is about Mn 165 USD ?There are various tender institutions like:

1.???Ministerio de Salud Pública (Ministry of Public Health) - MSP (Hospitals + UNAPS)

2.???Disease Control Program - DCPs - (HIV, TB, FP, EPI, PMAC)

3.???People’s Pharmacies (PROMESE)

4.???PROMESE social programs

5.???Armed Forces (including Ramón de Lara)

6.???National Police

7.???Dominican Social Security Institute

8.???Presidential Social Plan

Institutional market is Dominated by following companies

·??????SAAD Medical SRL,?

·????Hispomedica SRL

·??????Hospifar SRL,

·??????Novartis Caribe S.A.,

·??????Medek Pharma S.A.,

·??????Macrotech Farmaceutica SRL

·??????Laboratorio Laprofar SRL,

·??????Comimpharmas SRL,

·??????Linde Gas Dominicana SRL,

·??????Leterago SRL

·??????Anest SRL

PROMESE / CAL also known as People's Pharmacies

The Program of Essential Medicines and Central Logistics Support (PROMESE / CAL), is a single decentralized program or agency in the supply of pharmaceutical products, medical devices, sanitary ware and laboratory reagents that fulfils the demand of the National Public Health System.

Few Prices of PROMESE:

·??????Cod Liver Oil Emulsion (180ml bottle) $40.00

·??????Acetaminophen Paediatric Drops (Dropper bottle 15 ml) $15.00

·??????Medroxyprogesterone Acetate (Delayed Release 150mg/ml Vial) $ 50.00

·??????Water For Injectable (10 ml ampoule) $3.00

·??????Ambroxol Syrup (120 ml bottle) $15.00

·??????Amoxicillin + Clavulanic Acid Suspension (60 ml bottle) $60.00

·??????Betamethasone 0.1% Cream (Tube 15 g) $50.00

·??????Ceftriazone (1 g vial) $10.00

·??????Fluconazole (Capsule 150 mg) $2.50

·??????Fluconazole Suspension (60 ml bottle) $200.00

·??????Heparin (Vial 5000 IU / 5 mL) $75.00

·??????Dextrose Solution 5% - 1000 ml bottle - $ 40.00

·??????Ketoconazole 2% Cream Tube 30 g $ 12.00

Prominent India companies

Indian Company - Distributor / Agent

Msn Laboratories Private Ltd, India - Sued & Fargesa, S.R.L.

Cipla Ltd., India - Pharmaceutical Technology,. S.A (Pharmatech)

Caplin Point Laboratories, Limited India - Saldent Internacional, Srl

Nirma Limited, India - Sean Dominican, Srl

Scott-Edil Pharmacia Ltd., India - Disfarmaco, Srl

Kwality Pharmaceuticals - Clinimed, S.R.L.

Unicure (India) Pvt. Ltd - Beryl Pharma, Srl

Lark Laboratories (India) Limited; India - Distribuidora Nifarmed, Srl

Coral Laboratorio Ltd, India - Pharmax Med., S.A.

Bharat Parenterals Ltd, India - Pharma A.G. Trading, Srl

Gland Pharma Ltd, India - Pharmaceutical Technology, S.A (Pharmatech)

Claris Lifescience Limited, India - Ofiresa, Srl.

Tablets India Limited, India - Yomifar, Srl

Brawn Laboratories Ltd, India, - Metromed, S.A.

Inventia Healthcare, Pvt. - Sued & Fargesa, S.R.L.

Troikaa Pharmaceuticals Ltd., India - Pharmaceutical Technology,. S.A (Pharmatech)

Sun Pharmaceutical Industries Limited - Sued & Fargesa, S.R.L.

Theon Pharmaceuticals Ltd, India - Benayon Comercial

Ipca Laboratories Limited, India - Nutrifarma, S.A

Micro Labs Limited, India - Accent Pharmaceuticals International, Srl

Aculife Healthcare Private Limited, India - Sean Dominican, Srl

Top Companies Local Pharma Companies

1.??Laboratorio Magnachem International SRL

2.??Laboratorios Alfa SRL

3.??Laboratorios Rowe S.R.L.

4.??Maximo Gomez P. S.A.

5.??Laboratorios Antillanos Edmar S.A.

6.??Laboratorios Dr. Collado S.A.

7.??Mallen Veterinaria S.A.

8.??Glaxosmithkline Republica Dominicana S A

9.??Inmenol Industrial Laboratorios S.R.L.

10. Indo Quimica S.A.S.

Strengths

·??????Political Stability

·??????Largest Economy

·??????Increasingly attractive manufacturing destination for Medical Devices

·??????Dominican Republic is a significant player in Medical Device manufacturing

·??????Attractive Tax Incentives

·??????Strategic location - close of Miami (US)

Opportunities

·??????Competitive in free zone operations

·??????High productivity / Fast production

·??????Regulatory modernization

·??????Rising transportation costs from China have given the Dominican Republic an advantage

Weakness

·??????Small scale pharma manufacturing

·??????Stable Growth

·??????For medicines there is no guarantee of access or quality.

·??????Price restrictions

·??????The public healthcare system is complex

Threat

·??????A pharma market dominated by local companies

·??????Lower prices

·??????Local companies do not have to adhere to strict compliance guidelines

·??????Competition with local companies is strong.

Thanks and Regards,

Dr. Palak Gupta

+91 9971140354

[email protected]