Oman registers medicines through the Ministry of Health's Drug Safety Center, and every foreign product needs a locally licensed agent to file the application.

Who regulates medicines in Oman

Oman's national medicines regulator sits inside the Ministry of Health as the Drug Safety Center (DSC). Older material, including a 2016 mission report from the International Narcotics Control Board, refers to the same function under an earlier name, the Directorate General of Pharmaceutical Affairs and Drug Control. The Ministry's current service pages and its own 2025 dossier-submission guideline both use Drug Safety Center, so that is the name a supplier should work from today.

Two legal instruments sit behind the DSC's work: the Pharmacy Practice Law (Royal Decree 41/91), which governs pharmacy and warehouse licensing, and Minister of Health Decision No. 113/2020, whose Articles 63, 66, 68 and 69 set out registration, re-registration and variation of medicinal products. Registration and pricing decisions are made by the Technical Committee for Registration and Prices (TCR&P), which can approve an application, reject it, ask for more information, or set an approved price that is lower than the one the applicant requested.

Registering a product sourced from India

A new Marketing Authorisation Application (MAA) is submitted through the MOH e-portal, with the product dossier uploaded in eCTD format against the components the DSC publishes on its own site. Every submission goes through technical and business validation before assessment starts, and the DSC allows up to three rounds of written queries (a "wave") per application.

The DSC sorts new applications into two lanes:

1. Fast track, for new chemical entities with Stringent Regulatory Authority approval, vaccines with SRA approval or WHO Prequalification, biologicals and biosimilars with SRA approval, locally manufactured products, first and second generics, and products already registered under the Gulf Health Council's central drug registration route.
2. Normal track, for everything else.

The DSC's own performance targets (working days, excluding inspection time and any period an application is waiting on the applicant) are 90 days for a fast-track application processed on reliance, 180 days for a fast-track application needing full assessment, and 280 days for a normal-track full assessment. A locally submitted certificate is valid for five years; a renewal request is due six months before that certificate expires. Once a product is on the market, any change is filed as a variation: minor Type IA changes are notified within 14 days of implementation, Type IB changes wait 120 working days for the DSC's response before going ahead, and major Type II changes need prior approval, targeted at 180 working days.

Why a local agent is not optional

An Indian manufacturer or exporter cannot file a dossier with the DSC directly. Registration in Oman runs as two gated steps: a pharmaceutical company must first be registered with the DSC, and only that registered entity can then submit a product's Marketing Authorisation Application. In practice this means an Omani-licensed agent is appointed as the applicant and local sponsor of record, and stays in that role for the life of the registration, not just for the initial filing.

This isn't a formality. Pharmacy and pharmaceutical warehouse licensing in Oman runs through the DSC's own framework under the Pharmacy Practice Law (Royal Decree 41/91), so the agent has to be a properly licensed Omani pharmaceutical entity, not simply a distributor holding a general trade licence. Getting this relationship right before the first submission avoids the common failure mode: a dossier stalled or rejected because the party of record on file with the DSC has no standing to respond to a query. M Care Exports works alongside the buyer's appointed Omani agent to keep the dossier, the query responses and the agent's filings aligned through assessment.

How the GCC central registration route fits in

Oman is a founding member of the region's central drug registration system, run by the Gulf Health Council and referred to in Oman's own regulatory guideline by both of its short forms, GHC-DR and GCC-DR, with published guidance issued out of Riyadh. A product that already holds a GCC-DR registration certificate qualifies for Oman's fast-track lane, and the validity of the Omani marketing authorisation is then aligned to the GCC certificate's own validity rather than run as a separate five-year clock.

Oman also operates a narrower reliance route inside its own process: a product with an existing approval from the Saudi FDA, the UAE, or Kuwait (backed by a Certificate of Analysis) within the last two years can be assessed on reliance rather than full review, provided the submitted product information is declared identical to what the reference authority approved. Either route still requires stability data run to the GCC's guideline for a hot, humid climate (climatic Zone IV), which is a different test condition to the temperate-zone data some Indian manufacturers hold as their default package. See our note on how reliance pathways compare with a full national dossier for the wider Gulf and Africa picture.

How Oman's Ministry of Health buys medicines

DSC registration and public procurement are two separate gates. Bulk purchasing for MOH-affiliated hospitals and health institutions runs through the Directorate General of Medical Supplies (DGMS), which manages receipt, storage and distribution from central warehouses in Muscat, Nizwa and Salalah, plus an emergency reserve.

Before a company can bid on an MOH tender, it has to be pre-qualified by the DGMS under Ministerial Decision No. 109/2008, a separate technical and quality review from the DSC's product registration. A supplier can hold a valid DSC marketing authorisation and still not be pre-qualified to tender, and the reverse can also stall a shipment if the two approvals fall out of step. Our tender-response support for GCC public procurement is built around keeping registration status and pre-qualification status moving together rather than treating them as one step.

The document pack an Indian supplier needs to assemble

Most of the delay in an Oman filing comes from documents that were prepared for a different market and need reworking, not from the DSC's own review clock. A typical pack includes:

• A Certificate of Pharmaceutical Product (COPP) or free sale certificate from the Indian licensing authority (CDSCO or the relevant state FDA) for the actual manufacturing site.
• The manufacturing licence and current GMP evidence for that site, whether the product is a generic from a WHO-GMP-certified manufacturer or an originator brand supplied through a licensed Indian distribution channel.
• Batch Certificates of Analysis matching the samples submitted.
• Stability data generated for the GCC's hot, humid Zone IV conditions, not a temperate-zone package.
• A CTD dossier built to the DSC's eCTD components, with Module 1 documentation and any additional data the guideline calls for.
• A signed local agent appointment letter naming the Omani entity as applicant of record, plus notarisation and consular legalisation of the corporate and product documents as the agent's filing requires.

M Care Exports does not hold WHO-GMP certification itself and does not manufacture; as a merchant-exporter it assembles this pack from the actual manufacturing site's certificates for generics, or from the licensed Indian channel's documentation for originator brands, and hands the buyer's Omani agent a dossier built to the DSC's current format rather than a generic CTD template. Our dossier preparation service covers this rework, and a buyer can start with a specific product request or set up a trade account to move straight to sourcing once the regulatory path is confirmed.

Frequently asked

Does M Care Exports hold WHO-GMP certification itself?

No. M Care Exports is an Indian merchant-exporter, not a manufacturer, and it does not hold WHO-GMP or WHO-PQ status in its own name. For generic products it sources from WHO-GMP-certified Indian manufacturers and passes their certificates through to the buyer's dossier. For originator brands it sources through licensed Indian distribution channels. The manufacturing site's own GMP status, not M Care's, is what the Drug Safety Center reviews.

Can an Indian generic use the GCC reliance pathway for Oman registration?

Yes, if it qualifies. Oman's fast-track lane covers first and second generics on their own merits, and separately recognises products already registered under the Gulf Health Council's central registration route (GHC-DR/GCC-DR) or holding a recent approval from the Saudi FDA, the UAE, or Kuwait with a Certificate of Analysis. A generic without any of those doesn't lose eligibility to register, it is simply assessed on Oman's normal track, which carries a longer target timeline.

Who can act as the local agent for an Indian exporter's product in Oman?

It has to be an Omani-licensed pharmaceutical entity: pharmacy and pharmaceutical warehouse licensing in Oman runs through the Drug Safety Center's own framework under the Pharmacy Practice Law. The agent submits the registration request, is recorded as the applicant, and stays the point of contact with the Drug Safety Center for the life of the marketing authorisation, including renewals and variations.

How long does it take to register a medicine in Oman?

The Drug Safety Center's own working-day targets, excluding inspection time and periods waiting on the applicant, run from 90 days for a fast-track product assessed on reliance up to 280 days for a normal-track product needing full assessment. The Ministry's public e-portal listing for a standard product registration service states an end-to-end target of 360 working days. A locally issued certificate is then valid for five years, with renewal due six months before expiry.

Does DSC product registration automatically qualify a supplier for Ministry of Health tenders?

No. Product registration with the Drug Safety Center and company pre-qualification for Ministry of Health tenders are handled by two different directorates. Tender eligibility runs through the Directorate General of Medical Supplies under Ministerial Decision No. 109/2008, a separate technical and quality review. A registered product still needs its manufacturer or agent to complete DGMS pre-qualification before it can be offered into a public tender.

What stability data does Oman require for a hot climate?

Oman applies the Gulf Health Council's stability testing guideline for climatic Zone IV, the hot and humid zone, in Modules 2 and 3 of the product dossier. This is a different storage and testing condition to the temperate-zone (Zone II) data that some manufacturers hold as their default stability package, so Indian exporters targeting Oman should confirm their stability programme covers Zone IV conditions before submission rather than after a query is raised.