The new India-Oman CEPA provides immediate zero-duty access for Indian-manufactured finished medicines and vaccines entering the Omani market. Core active pharmaceutical ingredients (APIs), including penicillins and erythromycins, will also receive tariff certainty to enable long-term contracts and stable pricing. This is critical as Oman currently has limited domestic formulation production and is heavily dependent on imports.
A major highlight of the deal is a 90-day fast-track marketing authorization for products already approved by major global regulators like the USFDA, EMA, and MHRA. This bypasses the need for prior inspections for many products, significantly reducing time-to-market. For products where inspections are still required, approvals are now targeted within 270 working days.
India’s pharmaceutical exports to Oman have grown at a CAGR of 15.3% over the last four years, exceeding $54 million in FY24. The agreement also includes relaxed regulatory norms, with Oman agreeing to accept Good Manufacturing Practice (GMP) certificates from recognized international authorities, which will help domestic Indian companies lower their compliance costs.