Argentina’s national medicines regulator, ANMAT, has reclassified ten groups of active ingredients from prescription-only to over-the-counter status, a move that takes effect on 29 July and immediately alters how millions of patients access treatments for allergies, mild pain, motion sickness and skin conditions. The list includes oral antihistamines such as levocetirizine and fexofenadine, the antispasmodic trimebutine, the mucolytic carboxymethylcysteine, and topical ivermectin lotion at 0.5%, among others. The decision, published in the official gazette, means these products will no longer require a doctor’s prescription, but they also lose mandatory discounts from social security and private health insurers, shifting the cost directly to consumers at the pharmacy counter.

Regulators in Buenos Aires based the reclassification on a review of at least five years of domestic post-market surveillance data, which showed no serious adverse events that would alter the risk-benefit balance. The agency also cited precedents from the US Food and Drug Administration, the European Medicines Agency, and counterparts in Spain, France, Brazil and Colombia, where many of these substances are already sold without prescription. The change is part of a broader review ordered by Argentina’s health ministry in 2024, which had already moved proton-pump inhibitors and several dermatological products to OTC status. Officials argue that the drugs have wide therapeutic margins and treat symptoms easily recognised by patients, making them suitable for self-care.

Viewed from a public-health perspective, the shift intensifies a long-running tension between access and safety. Argentine pharmacy unions report that eight in ten citizens already self-medicate, a figure that has risen sharply over two decades. While the regulator insists the newly freed drugs carry low risk, medical associations warn that unsupervised use can mask serious underlying conditions and contribute to antimicrobial resistance when antibiotics are misused—though the current list does not include antibiotics. The loss of insurance discounts, confirmed by the government, adds a financial dimension: patients who previously obtained these medicines with a co-pay will now pay the full retail price, a change that consumer groups are watching closely.

Elsewhere, the US FDA has approved a new over-the-counter pain reliever combining 325 mg of acetaminophen and 110 mg of naproxen sodium, marketed as a 12-hour formulation for headaches, back pain and arthritis. The approval, announced this month, aligns with a White House initiative to expand access to non-prescription drugs. Meanwhile, a Class II recall of certain levothyroxine sodium tablets by Major Pharmaceuticals highlights the quality-control challenges that persist even in well-established OTC and prescription markets. In Mexico, pharmaceutical manufacturers are warning that new labelling requirements for public-sector medicines—mandating “Government of Mexico” and “prohibited sale” legends on 3.6 billion units—could add nearly 10 billion pesos in costs and risk supply disruptions if purchase guarantees are not strengthened. In Iran, health insurance authorities have exempted the lowest five income deciles and patients with rare or severe diseases from premium payments, a separate policy lever aimed at maintaining access to medicines through coverage rather than deregulation.

Argentina’s laboratories must now adapt packaging for new production lots to include a “Venta Libre” label and a QR code linking to the patient information leaflet, while existing stock can be sold through. The next milestone is the gradual appearance of the updated packaging on pharmacy shelves, alongside monitoring by ANMAT for any shifts in adverse-event reporting now that the products are used without a prescriber’s gatekeeping.