Argentina relaxes drug import rules, creates new export routes for India

New Delhi: Indian drugmakers could supply drugs directly to Argentina’s provincial governments under a revised regulatory framework that eases barriers to drug imports. The Indian Drug Manufacturers Association (IDMA) is seeking supply bids and indicative prices from domestic manufacturers to meet Tucumán province’s requirements, following changes to allow provincial authorities to import drugs directly.

Under the revised rules, Argentina now accepts Good Manufacturing Practice (GMP) certifications issued by regulators recognized by the World Health Organization (WHO), the Pan American Health Organization (PAHO) and the Geneva-based Program for Cooperation in Pharmaceutical Inspections (PIC/S), paving the way for direct importation of finished drugs. This could facilitate market access for Indian drug manufacturers with eligible certifications, potentially reducing the need for on-site factory inspections by Argentina’s drug regulator, the National Authority for Medicines, Food and Medical Technology (ANMAT).

The new framework removes longstanding regulatory hurdles for Indian manufacturers and allows direct exports of Indian drugs, active pharmaceutical ingredients (APIs) and medical equipment to Tucumán and other provinces. While Tucumán leads direct orders, Argentina’s new import rules will apply nationwide, allowing any province to buy Indian drugs.

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The direct trade push gained momentum following high-level bilateral talks between the Indian mission and Argentina’s provincial government officials, and the breakthrough could allow Indian exporters to expand deeper into Latin America.

“Following the recent visit of the (Indian) ambassador to Tucumán province and a positive meeting with the governor and the health minister, the embassy has received a list of drugs and medical supplies required by the province,” IDMA told its members in a memo seen by Mint.

“The revised framework recognizes GMP certificates issued by MERCOSUR bodies, PIC/S member agencies and WHO/PAHO recognized regulators, facilitating the acceptance of Indian pharmaceutical products in Argentina,” the statement added. Furthermore, under Argentine law, provincial authorities can import drugs for appropriate uses within their respective jurisdictions, he said.

Queries emailed to the Embassy of Argentina in New Delhi on October 18, spokespersons for the Ministry of Pharmacy, IDMA and the Ministry of External Affairs on October 19 remained unanswered till press time.

Growing exports

India exported pharmaceuticals worth $22.25 million to Argentina in 2025-26, up 22.8% from $18.12 million in 2024-25, according to data from the Ministry of Trade and Industry. Between April and July 2026, exports fell 2.16% to $10.28 million from $10.51 million a year ago. Total trade between the two nations will reach $5.968 billion in 2025–26, an increase of 25.5% from $4.75 billion in 2024–25.

Argentina is looking beyond protectionism as provinces seek cheap Indian generics, former Indian diplomat Deepak Bhojwani said.

“The use of provincial channels to import highly affordable Indian generics is a positive breakthrough. It will strengthen bilateral ties along with Indian investments in critical minerals and hydrocarbon imports from Argentina. While Argentina seeks global diversification, it remains heavily dependent on China despite President Javier Milea’s diplomatic overtures to Donald Trump. Argentina has significant economic interest in expanding ties with India and Colombas, ex-India. Said Venezuela and Cuba.

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India’s pharmaceutical exports rose 4.9% to $15.5 billion in the first half of 2026-27, up from $30.4 billion in 2024-25, data from the Indian Pharmaceutical Export Promotion Council (Pharmexcil) showed.

The new request from the Tucumán company starts the direct procurement of finished medicines for a period of three months. Diabetes treatment includes 6.6 lakh tablets of metformin (850 mg and 1000 mg), 2.1 lakh of teneligliptin (20 mg), 1.56 lakh of gliclazide (60 mg) and 60,000 tablets of glimepiride.

Wider cover

The order also covers an insulin pen used to regulate blood sugar in the treatment of diabetes. In addition, the province procures immunosuppressants and targeted biologics indicated for severe autoimmune disorders such as rheumatoid arthritis and systemic lupus, the prevention of organ transplant rejection and certain blood disorders, along with lipid-lowering therapies used to treat high cholesterol and prevent cardiovascular events.

In addition to medicines, Tucumán shares its hospital equipment acquisition plan for 2026, which seeks 14 fixed x-ray units, 7 mobile x-ray units, 4 mammography machines, an MRI machine, a CT scanner, 20 electric hospital beds, 15 respirators and 12 anesthesia tables.

Strategic experts said that Argentina’s Decree 150/1992, which lays down rules for the manufacture, sale, prescription and import of pharmaceutical products, will be a major milestone for Indian drug manufacturers.

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“India exports APIs and formulations to Argentina despite non-tariff barriers. India’s move from Annex II to Annex I of Argentina’s Decree 150/1992 would be a significant milestone to allow exports without ANMAT factory inspections. Argentina has historically resisted Indian drug imports primarily to protect domestic manufacturers who are unable to match the Indian government’s cost competitiveness. is a task in recent years, said Hari, given their importance in health care has been on the rise in recent years, Seshasayee, a visiting fellow at the Observer Research Foundation and a former adviser to the Panamanian foreign minister.

“For two decades, Argentina has held back the expansion of the India-Mercosur preferential trade agreement due to intense protectionism, especially in pharmaceuticals, where Indian drugs have faced serious barriers to registration. Under Milea, Argentina has gotten closer to India,” Bhojwani said.