Argentina eases drug import rules, creating new export avenues for India

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

Under the revised rules, Argentina now accepts good manufacturing practice (GMP) certifications issued by regulators recognised by the World Health Organization (WHO), the Pan American Health Organization (PAHO), and the Geneva-based Pharmaceutical Inspection Co-operation Scheme (PIC/S), paving the way for direct imports of finished medicines. This could ease market access for Indian drugmakers with eligible certifications, potentially reducing the need for on-site factory inspections by Argentina's drug regulator, National Administration of Drugs, Food and Medical Technology (ANMAT).

The new framework dismantles long-standing regulatory barriers for Indian manufacturers, enabling a direct export of Indian medicines, active pharmaceutical ingredients (APIs), and medical equipment to Tucumán and other provinces. While Tucumán is leading the direct orders, Argentina's new import rules will apply nationwide allowing any province to buy Indian drugs.

The direct trade push gained momentum after high-level bilateral talks between the Indian Mission and Argentina's provincial government leaders, and the breakthrough could allow Indian exporters to expand deeper into Latin America.

"Following a recent visit by the [Indian] ambassador to Tucumán Province and a positive meeting with the Governor and Health Minister, the Embassy has received a list of medicines and medical devices required by the province," IDMA said to its members in a communication seen by Mint.

"The revised framework recognises GMP certificates issued by MERCOSUR authorities, PIC/S member agencies, and regulators recognised by WHO/PAHO, facilitating the acceptance of Indian pharmaceutical products in Argentina," the communication added. Further, under Argentina's law, provincial authorities may import medicines for appropriate use within their respective jurisdictions, it said.

Queries emailed to the embassy of Argentina in New Delhi on 18 October, spokesperson for the department of pharmaceutical, IDMA and ministry of external affairs on 19 October remained unanswered till press time.

Rising exports

According to data from the ministry of commerce and industry, India exported pharmaceuticals worth $22.25 million to Argentina in 2025-26, an increase of 22.8% from $18.12 million in 2024-25. Between April and July 2026, exports dropped 2.16% to $10.28 million from $10.51 million a year ago. Overall trade between the two nations reached $5.968 billion in 2025-26, rising 25.5% from $4.75 billion in 2024-25.

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

"Using provincial channels to import highly affordable Indian generics is a positive breakthrough. It will bolster bilateral ties alongside India's investments in critical minerals and hydrocarbon imports from Argentina. While Argentina seeks global diversification, it remains heavily reliant on China despite president Javier Milei's diplomatic overtures to Donald Trump. Argentina holds substantial economic interest in expanding ties with India," Bhojwani, former Indian ambassador to Colombia, Venezuela, and Cuba, said.

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) data shows India's pharmaceuticals exports rose 4.9% in the first half of 2026-27 to $15.5 billion, following $30.4 billion in 2024-25.

Tucumán's new requisition initiates direct procurement of finished pharmaceuticals over three months. Diabetes treatments include 6.6 lakh Metformin tablets (850 mg and 1,000 mg), 2.1 lakh Teneligliptin (20 mg), 1.56 lakh Gliclazide (60 mg), and 60,000 Glimepiride tablets.

Broader cover

The order also covers pen insulins used for glycemic regulation in diabetes management. Additionally, the province is procuring immunosuppressants and targeted biologics indicated for severe autoimmune disorders like rheumatoid arthritis and systemic lupus, organ transplant rejection prevention, and certain blood disorders, alongside lipid-lowering therapies used to treat high cholesterol and prevent cardiovascular events.

Alongside pharmaceuticals, Tucumán has shared its 2026 hospital equipment acquisition plan, seeking 14 fixed X-ray units, 7 mobile X-ray units, 4 mammography machines, an MRI device, a CT scanner, 20 electric hospital beds, 15 respirators, and 12 anaesthesia tables.

Strategic experts said that Argentina's Decree 150/1992, which establishes rules for manufacture, sale, prescription, and imports of pharmaceutical products, would be a significant milestone for Indian drugmakers.

"India exports APIs and formulations to Argentina despite non-tariff barriers. Moving India from Annex II to Annex I of Argentina's Decree 150/1992 would be a significant milestone, allowing exports without ANMAT factory inspections. Argentina has historically resisted Indian drug imports primarily to protect domestic producers unable to match Indian cost competitiveness. Navigating this healthcare relationship remains an uphill task for both governments given its domestic significance, though recent years have seen progress," said Hari Seshasayee, visiting fellow at the Observer Research Foundation and former adviser to Panama's foreign minister.

"Argentina has for two decades held back the expansion of the India-Mercosur preferential trade agreement due to intense protectionism, particularly in pharmaceuticals where Indian drugs faced severe registration barriers. Under Milei, Argentina has reached out more to India," said Bhojwani.