India and Oman has signed a comprehensive economic partnership agreement (CEPA) on Thursday under which Oman will ease the regulations for the Indian pharma sector. As per the deal, Oman will grant immediate zero-duty access for key finished medicines and vaccines to the pharma manufacturers in India. “Core active pharmaceutical ingredients (APIs) such as penicillins, streptomycins, tetracyclines and erythromycins will also receive 0% tariff certainty, enabling stable pricing and long-term contracts,” the CEPA document showed.
In addition, pharma products which are approved by foreign agencies such as US Food and Drug Administration (USFDA), European Medicines Agency (EMA), UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and Australia’s Therapeutic Goods Administration (TGA) are eligible for 90-day fast-track marketing authorisations without prior inspections, subject to submission of complete assessment dossiers. “Where inspections are required, approvals are targeted within 270 working days,” as per CEPA.
Regulatory Harmonization
Oman is heavily dependent on pharma imports with limited domestic production of formulations. In FY24, India exported pharma products worth over $54 million to Oman, registering a compounded annual growth rate (CAGR) of 15.3% over four years.
The trade deal has also resulted in relaxed norms for domestic pharma companies wherein Oman will accept good manufacturing practice (GMP) certificates and inspection outcomes issued by recognised regulatory authorities which will significantly reduce duplication and compliance costs. “Acceptance of minimum stability data (by Oman) for fast-track products, with subsequent submission of full long-term studies, enables faster approvals while maintaining quality and safety standards,” the deal document said.
Operational Efficiencies
Experts said that the trade deal reflects a strong alignment on regulatory trust and healthcare priorities. “Duty-free access and fast-track clearances for globally-approved products will enable faster availability of quality medicines and vaccines. The recognition of GMP certifications is particularly important as it allows manufacturers to focus on scale, compliance and long-term partnerships, while supporting Oman’s growing and import-dependent healthcare needs,” said Bhavin Mukund Mehta, vice chairman of Pharmexcil and whole-time director of Kilitch Drugs.