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Oman to fast-track approval of Indian pharma products registered by USFDA, UKMHRA, EMA


Oman has also requested India to consider negotiating a preferential trade agreement.

Oman has agreed to fast track approval for Indian pharma products that are already registered by the US Food and Drug Administration (USFDA), UK drug regulator MHRA and European Medicines Agency, the commerce ministry said on Wednesday.

Oman has also requested India to consider negotiating a preferential trade agreement.

The issues came up for discussions during the 10th session of the India-Oman Joint Commission Meeting (JCM) here.

It was co-chaired by Commerce and Industry Minister Piyush Goyal and Oman’s Minister for Commerce, Industry and Investment Promotion Qais bin Mohammed al Yousef, who is in India with a 48-member delegation comprising senior officials and business leaders.

“Oman has agreed to India’s request for fast tracking of approvals of registration of Indian pharma products already registered by USFDA, UKMHRA, EMA,” Joint secretary in the Department of Commerce Srikar K Reddy told reporters here.

Currently, Indian pharma sector accounts for only 3.5 per cent of Oman’s total pharma imports.

“We expect that with the fast tracking of registration of Indian pharma products, we can significantly gain in the Omani pharma market which is estimated at USD 850 million,” Reddy said.

Both sides also agreed to address all issues pertaining to tariff and non-tariff barriers.

On the preferential trade agreement, Reddy said Oman has requested India to consider a PTA.

“We have noted that request and we will be undertaking feasibility study and will take a final decision based on that joint study,” the official said.

One of the significant outcomes of the meeting include agreement on expeditious conclusion of all MoUs/ agreements under discussion, including on standards and metrology, Double Taxation Avoidance Agreement, Bilateral Investment Treaty, and Rupay card acceptance in Oman.

On the Rupay card issue, Reddy said Oman has conveyed that it will positively consider India’s request.

Further, India has asked the Omani side to send a technical team to India regarding discussion on technical standards for maximum residual limit in Indian rice exports.

Bilateral trade between the two countries has increased from USD 5.4 billion in 2020-21 to USD 9.94 billion during 2021-2022. India’s exports were worth USD 3.1 billion and imports at USD 6.84 billion in 2020-21.

Indian firms have invested heavily in Oman in various sectors like iron and steel, cement, fertilizers, textile, cables, chemicals, automotive. There are over 6,000 Indian enterprises and establishments in Oman with an estimated investment of USD 7.5 billion.

Cumulative FDI equity inflows from Oman to India during April 2000-December 2021 have amounted to USD 558.68 million.
Oman is a member of GCC customs union and has a population of 4.5 million. About 6 lakh Indians are there in Oman.

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