India–Oman CEPA likely to kick in within 3 months, pharma approvals to be fast-tracked

FTA

The trade deal between India and Oman is likely to become operational within the next three months, offering duty-free access to a range of Indian labour-intensive exports and faster approvals for pharmaceutical products, Commerce Minister Piyush Goyal said on December 19.

“The Oman-United States trade agreement, signed in 2006, took nearly three years to be implemented. Learning from that experience, India and Oman have decided to operationalise this agreement much faster,” Goyal said during a briefing.

The Commerce Ministry added that the agreement provides for automatic approvals within 90 days for Indian pharmaceutical products and manufacturing units that are recognised by multiple countries.

India and Oman signed the Comprehensive Economic Partnership Agreement (CEPA) on December 18, the second day of Prime Minister Narendra Modi’s visit to the Gulf nation.

As part of the trade deal, India will cut duties on about 78 percent of its tariff lines, covering nearly 95 percent of imports from Oman, with sensitive products given access mainly through tariff-rate quotas.

On the other hand, the trade deal gives India zero-duty access on 98.08 percent of Oman’s tariff lines, covering 99.38 percent of Indian exports by value.

During 2024‑25, bilateral merchandise trade between India and Oman reached $10.61 billion, up from $8.94 billion in 2023‑24, and during April–October 2025 it stood at $6.48 billion.

Merchandise exports to Oman stood at $4.06 billion in 2024‑25 and $2.57 billion from April–October 2025, showing about 5 percent growth, while imports from Oman were $6.55 billion in 2024‑25 and $3.91 billion in the first seven of the current fiscal.

Services exports and imports grew from $397 million and $101 million in 2020 to $617 million and $159 million in 2023, respectively, with top export sectors including telecommunications, computer and information services, other business services, transport and travel, and top import sectors such as transport, travel, telecom, and other business services.

Pharma fast-track

The commerce ministry said that under the India-Oman Comprehensive Economic Partnership Agreement, key finished medicines and vaccines will enjoy binding zero-duty access, boosting competitiveness in both public and private procurement.

Core active pharmaceutical ingredients (APIs) such as penicillins, streptomycins, tetracyclines, and erythromycins also receive zero-tariff certainty, enabling stable pricing and long-term contracts for exporters.

The CEPA also introduces regulatory fast-tracking for products approved by stringent authorities including the USFDA, EMA, UK MHRA, and TGA. These products can receive marketing authorisations within 90 days without prior inspections, while approvals requiring inspections are targeted within 270 working days.

In addition, Oman will recognise GMP certificates and inspection outcomes issued by recognised regulatory authorities, reducing duplication and compliance costs for exporters.

The pricing framework for imported pharmaceuticals will be determined in line with local market conditions and public health priorities, supporting affordability and sustainable supply.

To further accelerate market access, the agreement allows streamlined stability requirements, accepting minimum stability data for fast-track products with full long-term studies submitted later, ensuring faster approvals without compromising quality and safety standards.

Oman’s pharmaceutical market was valued at $302.84 million in 2024 and is projected to reach $473.71 million by 2031, growing at a compound annual growth rate (CAGR) of 6.6 percent between 2025 and 2031.