New Delhi: India's pharma exports to Oman will get a boost as the Gulf nation will provide duty-free access to key finished medicines and vaccines, besides fast-tracking of regulatory approvals for domestic goods. Core active pharmaceutical ingredients (APIs) such as penicillins, streptomyces, tetracyclines, and erythromycins also get duty-free access in Oman's market, according to the pact.
The comprehensive economic partnership agreement (CEPA) was signed on Thursday in Muscat. As per the agreement, products approved by USFDA, EMA (European Medicines Agency), UK's MHRA (Medicines and Healthcare products Regulatory Agency), and Australia's TGA (Therapeutic Goods Administration) will be eligible for 90-day fast-track marketing authorisations without prior inspections, subject to submission of complete assessment dossiers.
Where inspections are required, there is a target that Indian pharma products may get approval within 270 working days. Oman will accept GMP (Good Manufacturing Practice) certificates and inspection outcomes issued by recognised stringent regulatory authorities, as it will reduce duplication and compliance costs. The move will help Indian drug manufacturers to get speedy market access in Oman. Oman's pharmaceutical market was valued at USD 302.84 million in 2024 and is projected to reach USD 473.71 million by 2031, growing at a CAGR of 6.6 per cent (2025-?31). The market is heavily import-dependent, with limited domestic production.
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