Oman to expedite registration process of Indian medicinal products approved by US FDA, UK MHRA or EMA

Oman has agreed to the Pharmaceuticals Export Promotion Council of India (Pharmexcil)’s proposal to expedite the review of registration process of medicinal products exported from India based on approvals by regulatory authorities like the US FDA, UK MHRA or EMA.

The value of Oman pharmaceutical market is estimated at USD 875 million with a CAGR of 10.8 per cent. The major market is for branded and prescription drugs, especially in anti-infective segments and the major distribution channels are hospital pharmacies. Increasing prevalence of chronic diseases and lack of local pharmaceutical production facilities provide opportunities for Indian drug makers in Oman.

“The Department of Pharmaceuticals of Oman has requested the Pharmexcil to provide the list of interested companies who want to register their products, which are already approved by US FDA or UK MHRA or EMA, in Oman. Pharmexcil has, therefore, informed our member exporters who have US FDA, UK MHRA or EMA authorisations and are interested in registering their products in Oman, to express their interest by filling up the below form latest by September 15, 2023,” informed Uday Bhaskar, director general (DG), Pharmexcil.

He further informed that Pharmexcil has received a communication from the Department of Pharmaceuticals and Embassy of India in Oman regarding international cooperation efforts being taken in the area of pharmaceutical sector with the Sultanate of Oman. It is learnt that during the 10th India-Oman Joint Commission Meeting held on May 11, 2022, Indian side had requested Omani side to consider and accept Indian pharmaceutical products, which have been registered with US FDA, UK MHRA and EMA without need to go through the lengthy registration process in Oman for each product.

The UK MHRA Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency.

A Market Research Report on the Pharmaceutical Sector in Oman has also been done to assess the Oman pharmaceutical market with respect to the Indian pharmaceutical industry. This study has been done towards ensuring mutually beneficial collaborations between both the countries where Oman gets medicines at an affordable rate and the Oman market also offers growth avenues for the Indian pharmaceutical industry.

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