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Paraguay based Dutriec SA invites Indian companies to register and export 134 lifesaving medicines
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Shardul Nautiyal, Mumbai
August 29 , 2023
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A Paraguay based company named Dutriec SA has invited Indian pharma companies to register and export 134 kinds of lifesaving medicines for the treatment of various types of chronic ailments like cancer, hypertension, cardiac disorders, diabetes and mental disorders, among others.
In 2022, Paraguay had imported around 431.9 million USD worth of pharmaceutical products, reaching the highest figure for these imports during the period depicted. A year earlier, pharmaceutical imports in the South American country amounted to about 396.3 million USD. Paraguay is a landlocked country in South America. It is bordered by Argentina to the south and southwest, Brazil to the east and northeast, and Bolivia to the northwest.
The medicines include names like abciximab used to keep blood from clotting, adalimumab which is an alpha monoclonal antibody used to treat rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn disease and ulcerative colitis among others, human albumin used to treat blood volume loss, amantadine used to treat people in the early stages of Parkinson's disease and asparaginase which is a chemotherapy drug used in the treatment for acute lymphoblastic leukaemia (ALL).
Medicines also include atezolizumab which is a type of immunotherapy drug used in the treatment for a number of different types of cancer, atorvastatin used to treat high blood cholesterol and prevent heart disease and strokes, atracurium is a non-depolarizing neuromuscular blocking drug, azathioprine is used to prevent organ rejection in people who have received a kidney transplant and to treat rheumatoid arthritis, basiliximab is a monoclonal antibody used to prevent rejection in kidney transplants, Bevacizumab is a medication used to treat a number of types of cancers and a specific eye disease, bleomycin used to treat cancers like Hodgkin's lymphoma, non-Hodgkin's lymphoma, testicular cancer, ovarian cancer, and cervical cancer among others and capecitabine which is an anticancer medication used to treat breast cancer, gastric cancer and colorectal cancer.
“The Pharmaceuticals Export Promotion Council of India (Pharmexcil) is in receipt of communication from Embassy of India, Paraguay, wherein an Dutriec SA, a Paraguay based Company is interested in importing and registering a list of products to Paraguay from India. Importing pharmaceutical products into Paraguay entails adhering to a specific set of requirements and documentation procedures. To assist Indian pharma companies in this process, Pharmexcil has urged the companies to review the essential prerequisites for registering pharmaceutical products in Paraguay, as specified. Member companies having business operations in Paraguay and those willing to enter the Paraguayan market may take advantage of this opportunity and contact Dutriec SA, directly and keep our Embassy in loop (hoc.asuncion@mea.gov.in). Juan Andrés Fernández, director, Dutriec SA can be contacted at +595 981 540 151 and Email:juan.fernandez.dutriec@gmail.com,” informed Uday Bhaskar, director general, Pharmexcil in a Circular.
The requirements that are required to register products in Paraguay is a Good Manufacturing Certificate (GMP) certification from a high surveillance country. The GMP must be from the same line of the product that is intended to be registered. It must be shown that the product is being marketed in a country with high surveillance. In other words, it is not enough to only have the high surveillance GMP, but also to have a Certificate of Pharmaceutical Product (CoPP) issued by a high surveillance country.
The following documentation is also required like authenticated copy of branded title, authenticated copy of trademark use license, authenticated copy power of attorney/representation use, authenticated copy of third-party relations, authenticated copy of GMP of the manufacturer/s issued by the local sanitary authority, consularized and apostilled (certified), authenticated copy of Good Storage Practices (GSP) from the applicant or the company in charge of the storage issued by the local sanitary authority, consularized and apostilled (certified).
This also includes manufacturing/fabrication process and process characterization of the API and final product with their respective data like physicochemical properties, biological activity, immunochemical properties, impurities, analytical techniques, non-clinical evaluations, in vitro studies, in vivo studies, clinical evaluation, pharmacokinetic studies, pharmacodynamic studies, efficacy study, safety study and immunogenicity study among others.
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