Argentina Pharma Market

Population:      4.4 Mn

Capital:    Buenos Aires is the country’s capital and largest city

Currency:  Argentine Peso

Official Language:    Spanish

Exchange Value:    1000 Argentine Peso equals USD 49  

Major Cities:    Buenos Aires, Córdoba, Rosario, Mendoza, Tucumán, La Plata, Mar del Plata

International Borders/Surrounding Countries: Argentina is located in Southern South America, bordering Chile on the west, Bolivia and Paraguay on the north, Brazil and Uruguay on the northeast, and the Atlantic Ocean on the east.  It’s the second largest country in South America (after Brazil

Destination Sea Port or Airport:   Bahía Blanca is the most important seaport city of Argentina, located south of the Province of Buenos Aires and the second largest on the Atlantic Ocean. Its seaport is one of the largest in the country, being the only one with a natural depth of more than 10m.

Market Value in USD:

§ Pharmaceutical market around USD 10Bn is expected to reach USD15 Bn by 2020.

§ Pharma sector most dynamic sectors in the Argentinean economy, and is now an engine of economic growth.  Domestic pharma industry dominates the international pharma sector in terms of revenue.

§ Argentina is the 3rd largest pharma market in Latin America behind Brazil & Mexico.

§ Argentina has a relatively well-developed pharmaceutical industry. Local production accounts for 85% of the market by volume & 60% market share by value. But still imports have risen sharply due to high inflation.

§ Exports its products and very competitive market.

§ Around 110 Mfg plant, Foreign owned plants 17.

§ The OTC segment is another area that holds a lot of potential for growth in the Argentinean pharma market. 25% by total sales and 10% by value. Rx market approx 90%.

§ Access to medicine in Argentina is among the best in the world.

Market Growth:        14%-17% CAGR

Type of market: Maintains high Latin American standards. "

Top Companies: Roemmers one of the top company, more than 9% of the market, followed by Bayer, Gador, Elea, Bago, Montpellier.

Pharma Star, the biggest distributor in Argentina command 65% of the total distribution of drugs.

Bago is the only Argentinean Phama Company with a potential to develop a blockbuster drug that could catapult them into the global to 50.

Name of FDA: ANMAT (Adminstracion Nacional de Medicamentos, Alimentos y Tecnologia Medica ? National Administration of Drugs, Food Products and Medical Technology): The regulatory agency that licenses the import, manufacture and marketing of medicines and medical devices as well as foodstuffs.

Inspection of all Indian drugs and medicines had to be undertaken by the regulatory body, ANMAT 

Offer incentives for the registration of generics/copies/similars.

Registration Time: 12 months for New Active Substance.

Generally, it takes more than 90 days and could extend to up to more than one year depending on the complexity of the product's technical aspects.

Products into three categories based on the countries in which they are manufactured:

1. Article 3 Product: Generic Product

Timeline for approval: About 12 months

> Drug products manufactured in Argentina or in an Annex II country, when there is a similar drug product already registered in Argentina.

> Drug products manufactured in Argentina, with marketing authorization in any Annex I country, even if there are no similar products registered in Argentina.

2. Article 4 Product

Timeline for approval: About 10 months

> Drug products with marketing authorization in at least one Annex I country.

3. Article 5 Product: New Product

Timeline for approval: Not less than 3 years

> Drug products manufactured in Argentina, when there are no similar products already registered in Argentina.

> Drug products manufactured in an Annex II country and not marketed in any Annex I country, when there are no similar products already registered in Argentina.

> Drug products manufactured in a non-Annex I, non-Annex II country, and not marketed in any Annex I country."

Validity of Registration: 5 years

Argentina there are no generics and suggesting that the quality of the pharmaceutical products classified as similar"

Registration Fees: 2,308 for NCE (2010)

$1,000 for original drugs??

$333 for generic/similar drugs??

Plant inspection:      No

Type of Dossier:      

CTD Dossier, Pricing is not the part of approval of drug. CPP need to be legalized from embassy.

There are two types of registry:

Registry of medicinal products to be manufactured in Argentina and those to be imported from countries listed in Annex II of the Decree 150/1992 (Australia, Mexico, Brazil, Cuba, Chile, Finland, Hungary, Ireland, China, Luxembourg, Norway and New Zealand) that are similar to others already registered with ANMAT.

For Annex II countries, manufacturing facilities are required to be inspected and approved by the Argentinean Department of Health before export of these pharmaceutical products into Argentina. Where such a site GMP inspection is required, this should be requested as early as possible as, due to resource constraints, the site inspection may take up to two years to occur.

Registry of medicinal products to be manufactured in Argentina, the marketing of which is authorised in at least one of the countries listed in Annex I of Decree 150/1992 (United States, Japan, Sweden, Switzerland, Israel, Canada, Austria, Germany, France, United Kingdom, the Netherlands, Belgium, Denmark, Spain, Italy.

Approval time for Argentina was twice as fast as for Brazil, this is likely due to the fact that Argentina uses a verification approval route whereas Brazil typically conducts a full dossier review.

Brief:

Major Challenges: Control on imports & Exchange rates, squeezing margins, volatile inflation.

The market tightly controlled and dominated by the local distributors of multinationals from the US, European Union and Switzerland

Argentine citizens today have access to specialty or high technology products due to a solid reimbursement system.

Apart from LATAM, Argentine products reach almost every corner of the world like Southeast Asia, Eastern Europe, parts of Africa, Lebanon, Pakistan and Kazakhstan as important markets for the industry.

Domestically manufactured products are predominant 71% percent over imported products 29%.

Average marketing expenses 22.5%. 

Argentina permits 100% foreign ownership.

Indian Pharma Companies:

India is exports of pharmaceutical products to Argentina were limited to raw materials and fine chemicals. 

The limited generic drugs exporters included Lupin, Ranbaxy and a few vaccine manufacturers. In 2012-13, India sold $44.85 million worth of bulk drugs to Argentina

Indian companies with USFDA and EU certification can export freely to Argentina.

Argentina is in the process of submitting a list of 20 drugs for immediate import from India.

The prices of medicine in Latin American countries were three to twenty times the prices of medicine in India.

India sold $44.85 million worth of bulk drugs to Argentina.

Strides Arcolab Limited has a big market for its HIV drugs in Argentina. Catering to a niche market or segment like AIDS will be fruitful for Indian companies.

There is a trend in decreasing of Pharmaceutical imports to the country and growing exports from the country.

Argentina accepted Ayurvedic medicines. Companies such as Dabur and Himalayas have already made entry.

Argentina and Brazil are looking for a manufacturing tie up with Indian companies for intermediates and raw materials for pharmaceuticals that is essentially life saving

Dr. Palak Gupta

 +91 9971140354

[email protected]