Colombia looks to India for pharmaceutical raw material

Updated: September 26, 2019 8:17:39 PM

Nearly 65% market share is held by Colombian local Pharmaceutical Manufacturers and 35% by Multinational Companies, where 43% are Generic medicine, 41% are Patented medicine and 16% are OTC.

Price control over drugs and medical devices is determined under the National Commission of Medicines and Medical Devices scope.

By Sandeep Wasnik

Colombia Pharmaceutical market is the 4th largest market in Latin America with a CARG of 7.3% and to participate in this market, it must be considered that the country is self-sufficient 400 laboratories and maquilas. This means that Colombia is the producer of medicines. However, for the requirement of raw materials, such as the active ingredient and excipients, Colombia is fully dependent on imports.

How can Indian Pharmaceutical Companies enter the Colombian market?
The Colombian National Food and Drug Surveillance Institute (Spanish: Instituto Nacional de Vigilancia de Medicamentos y Alimentos or INVIMA) is a regulatory authority in charge of inspecting and supervising the marketing and manufacturing of health products. And also, in identifying and evaluating the violation of health standards or procedures, and implementing best practices and providing medical approval for the import and export of products.

To enter the Colombian market, Pharmaceutical Medicine and Equipment should be approved and registered by INVIMA to manufacture, sell, import or export. The registration of medicines and equipment in Colombia is the fastest as compared to other Latin American countries and this process usually takes 90 to 180 days to get it register and approval by INVIMA. The registration of medicine is valid for 5 years and medical equipment is for 10 Years. An Indian company which is looking to export medicines and equipment needs to appoint a Colombian Legal Representative who will submit registrations to INVIMA.

Now, the question is: What about the prices of drugs and devices regulation? Price control over drugs and medical devices is determined under the National Commission of Medicines and Medical Devices (Spanish: Comision Nacional De Precios De Medicamentos Y Dispositivos Médicos) scope. The National Commission of Medicines and Medical Devices annually assigns a reference price for all medicinal products marketed in the country. This price is considered a regulatory tool to establish the price for each commercial presentation of the medicinal product.

India can use Colombia as a regional platform to access the surrounding nations like Argentina, Peru, Chile and Ecuador and also can take advantage of Colombia free trade agreements (FTA) with the United States, the European Union and the Pacific Alliance (comprises of Chile, Mexico, Colombia, and Peru)
Indian exports of Pharmaceutical Products to Colombia:

Till date, India stands consistently on 9th position as an exporter of Pharmaceutical Products to Colombia from more than 10 years. The Indian export of pharmaceutical products is rising and can be calculated by a linear equation (y = 0.0008x – 26.868). Info-graph shows the per month export of Pharmaceutical Products (HS Code 30) from January 2010 till April 2019 from India to Colombia.

Overview of Colombian Pharmaceuticals Market:
Nearly 65% market share is held by Colombian local Pharmaceutical Manufacturers and 35% by Multinational Companies, where 43% are Generic medicine, 41% are Patented medicine and 16% are OTC. An overview of the type of pharmaceutical medicine demanded by Colombians are – 46 % mainly for analgesics (Especially for Migraine pain relieve and Musculoskeletal), 24% Cough and Colds Relieve medicine and Allergies medicines, 14% Digestive medicines, 10% Dermatological products and 8% are those demanded by the elderly population over the age of 65 years. These figures clearly indicate the consumption pattern of medicine in Colombia. The import of pharmaceutical products demand is rising and can be calculated by a linear equation (y = 0.0204x – 677.44) Info-graph show the per month import of Pharmaceutical Products from January 2010 till April 2019 in Colombia from the world.

Info-graph of Pharmaceutical Products export from India to Colombia clearly shows which type of Pharmaceutical Products is importing in Colombia by its classification, HS Code – 3004 was recorded $49.83 Million in 2018 with 61.44% in overall Pharmaceutical Products exports from India. This 4 Digit HS Code – 3004 is Categorized for “Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses including those in the form of transdermal administration or in forms or packings for retail sale (excluding goods of heading 3002, 3005 or 3006). While other 4 Digit HS Code – 3003 was recorded $16.73 Million with a 20.63% and is categorized for “Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excluding goods of heading 3002, 3005 or 3006)”.

Colombia Pharmaceuticals Import and Export Market:
Colombia has a huge requirement of raw materials such as the active ingredient and excipients to produce medicine where the local companies depend on Active Pharmaceutical Ingredient (API). The total export of Pharmaceutical Products from Colombia to the world is recorded at $350.629 Million in 2018 and on the other hand, the total Import of pharmaceutical products from the world in 2010 was $1.469 Billion and in 2018 was $2.394 Billion. Info-graph shows the Top 10 Export of Pharmaceutical Products for Colombia.

Info-graph of Pharmaceutical Products Imports in Colombia from the world clearly shows that Pharmaceutical Products which is classified by HS Code – 3004 was recorded $1427.50 Million in 2018 with 59.63% in overall Pharmaceutical Products import. This 4 Digit HS Code – 3004 is Categorized for “Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses including those in the form of transdermal administration or in forms or packings for retail sale (excluding goods of heading 3002, 3005 or 3006) have more.

Yes, Colombia has bigger opportunities for imports of raw materials and experiencing demands for pharmaceutical products as a result of the country’s positive economic landscape, booming population and government policies to broaden access to medicines through the expansion in health insurance and affordable drug coverage. It is the first country in the region to achieve Universal Health Coverage, offering a benefits package to all citizens regardless of whether they contribute or not.

(The author is Latin America and the Caribbean Countries Market Expert. Views expressed are personal.)

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