Why Farbe Firma is the Leading Injectable Manufacturer in Seychelles
Why Farbe Firma is the Leading Injectable Manufacturer in Seychelles
Last Updated: 19 September 2026
TL;DR: Seychelles runs no product marketing authorisation system: no medicines register, no dossier requirement, no authorisation holder. What exists instead is an import permit issued per consignment by the Trade Department on the approval of the Ministry of Health's Medicines Regulatory Unit, held by a Seychelles-registered importer. Seychelles is high income, so the donor quality architecture that governs most of Africa does not apply, and much of the public volume now moves through a WHO-facilitated island-states pooled tender.
Key Takeaways
The statutes in play are the Pharmacy Act, Cap. 169 of 1899, the Public Health Authority Act 2013 and the Public Health Act 2015. The 2013 Act's registration provisions cover health practices and premises, not products, and its schedule of health related products reaches tissues, biological samples and re-export goods. None of the three creates a product marketing authorisation.
Seychelles told the WTO in its own import-licensing notification that apart from the licence there are no other administrative procedures required prior to importation and no other conditions attached. That is the closest thing to an affirmative statement that the permit is the gate, and it is why the position here is a proven absence rather than something we merely failed to find.
With no product register there is no published list of trusted foreign authorities, so whether Seychelles accepts India's CDSCO is a question that does not arise. It is neither an open door nor a closed one. Two older provisions can look like such a list and are not: the Pharmacy Act names pharmacopoeias, and an 1899 clause refers to a foreign medical academy without naming any agency.
The regulatory weight sits on the local importer, not on the foreign manufacturer. The permit applicant must be a Seychelles-registered entity with a business registration certificate, a valid licence from the Seychelles Licensing Authority and a TIN certificate, and the permit is non-transferable. The practical prerequisite for entry is a credible local partner rather than a dossier.
Introduction: What an Injectable Manufacturer in Seychelles Actually Has to Clear
Seychelles is an unusual market to write about, because the usual questions have no usual answers. There is no register to enter, no dossier to file and no authority to be recognised by. Even the scale is contested: the Ministry of Health's 2025 vital statistics give a resident population of 122,730, of whom 101,390 are Seychellois, while the World Bank reports 121,354 for 2024 and UN-derived estimates run near 135,000. We print those and decline to reconcile them.
What there is instead is a per-consignment import permit, a Ministry of Health unit that must approve it, a quality control laboratory that tests what arrives, and a licensed local importer who carries the obligation. One caution on the law: the Public Health Act 2015 commences by ministerial notice in the Gazette and we found no commencement notice, so we give no date for it. The Public Health Authority Act 2013 demonstrably operates.
What Sets a World-Class Injectable Manufacturer in Seychelles Apart
The first discipline is not mistaking an absent register for an absent standard. Sources disagree even on the permit: the Trade Department's 2025 guide says it runs six months and is renewable once, while the WTO notification describes an open period of one year but adds that medicinal products require a licence per shipment. Both are printed because we are not choosing, and the point they agree on is that medicines move consignment by consignment.
The second is precision about what we could not establish. We found no Seychelles instrument requiring a WHO-GMP certificate, a certificate of pharmaceutical product, or approval of the foreign manufacturing site. That is an absence of evidence in published sources, not a published statement that no such requirement exists, and it certainly is not a promise that none will be asked for commercially. Confirm current practice with the Medicines Regulatory Unit before shipping.
Quality Systems Behind Every Batch Shipped to Seychelles
Farbe Firma manufactures sterile injectables under WHO-GMP certification with ISO Class 5 aseptic filling in Gujarat, India, supported by in-house HPLC, GC, LAL endotoxin and Karl Fischer testing and ICH Q1A and Q1B stability programmes. Every batch ships with a certificate of analysis traceable to retained samples, and CTD and ACTD dossiers are prepared for the 30+ countries we export to. Here that file is not a submission requirement; it is what a permit officer and a tender evaluator each ask for on their own terms.
It is also worth being precise about India's standing in the WHO framework, because it is commonly overstated. CDSCO appears on WHO's transitional listed-authority list with a scope of Vaccines. It is not listed for medicines. So any tender clause phrased as WHO-listed or maturity level 3 and above must be read carefully: a listing that satisfies it for vaccines does not carry a sterile injectable medicine. We would rather say that plainly than let a client find it inside a bid.
Why Farbe Firma is the Trusted Injectable Manufacturer in Seychelles for Global Buyers
The regional layer is quieter than an Africa playbook would predict, and that is the finding rather than a gap. Seychelles both signed the African Medicines Agency treaty on 9 February 2020 and ratified it on 13 August 2020, and signature and ratification are not the same act. Neither currently imposes a marketing authorisation or supplies a reference list. It takes part in the SADC collaborative registration procedure only as a non-active member, and that procedure states it is not legally constituted.
The donor layer is closed, and for a supplier that is the commercially important fact rather than a disappointment. Seychelles is high income on the World Bank's current classification, is absent from the Global Fund's 2026 eligibility list and sits outside Gavi's thresholds. It buys with its own money, which means the quality bar is set by the buyer in front of you and not by a funder's policy document.
So the place to watch is probably not the national tender board. Much of the public volume now moves through the African Small Island Developing States pooled procurement initiative; WHO reports that Seychelles took its first consignment through it in 2024 and that a further cycle is being prepared. The first tender was floated on the United Nations Global Marketplace under WHO procurement rules, drew 37 bidders and produced six suppliers from five countries, India among them. Its eligibility criteria we could not obtain, and will not characterise.
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Frequently Asked Questions (FAQ)
Do I need to register my injectable before it can be imported into Seychelles?
No, because there is no product register. The Pharmacy Act of 1899, the Public Health Authority Act 2013 and the Public Health Act 2015 create no marketing authorisation, and the 2013 Act's registration provisions reach practices and premises rather than products. What is required is an import permit for the consignment, issued by the Trade Department on the approval of the Medicines Regulatory Unit. That Unit clears consignments; it does not issue marketing authorisations.
Does Seychelles accept approval by India's CDSCO?
Neither answer is available, and that is not evasion. Because Seychelles operates no product register, it publishes no list of trusted foreign authorities, so CDSCO is neither recognised nor excluded by name. Two provisions can be mistaken for such a list. The Pharmacy Act names pharmacopoeias, which are books rather than agencies, and an 1899 clause refers to a foreign medical academy while naming no agency. Neither is a reliance pathway.
What are the registration fees and review timelines?
There is no product registration, so there is no fee and no review timeline, and any number offered for either should be treated as invented. The costs that do arise attach to the consignment and the importer: the import permit, the local entity's business registration and licence, and the ordinary customs process. We are deliberately not quoting a permit fee, because the two sources we read disagree even about how long a permit lasts.
Who buys injectables in Seychelles, and do I need a local partner?
Public demand runs through the Health Care Agency and Seychelles Hospital alongside the regional pooled tender, and the import permit must be held by a Seychelles-registered importer and is non-transferable. We found no law requiring a foreign supplier to appoint a local agent, and will not claim the opposite. What is published and checkable: foreign bidders may join open international bidding but not open national bidding, and a margin of preference of up to 20 per cent may take account of association with local partners.
Which injectable categories actually have demand there?
Renal care is the clearest signal. Seychelles Hospital recorded 33,565 dialysis sessions in 2025 against 28,282 in 2023, with 245 patients on long-term dialysis, and the 2026 budget allocates SR 87 million to haemodialysis; the 2024 essential medicines list carries iron sucrose and the epoetins. Oncology is the second, with the hospital pharmacy doing its own aseptic cytotoxic reconstitution and carboplatin, cisplatin and paclitaxel listed as vials. One caution: the Ministry's own unit makes small-volume intravenous fluids, so basic fluids are not an open field.
Technically Reviewed By: Maulik Sudani (Technical Expert) | Jignasu Sudani (Technical Expert), Farbe Firma Pvt Ltd, Gujarat, India.
Farbe Firma Pvt Ltd - WHO-GMP certified sterile injectable manufacturer and CDMO, Gujarat, India. ISO Class 5 aseptic filling, CTD/ACTD dossiers, exporting to 30+ countries. director@farbefirma.orgRequest a Quote / View Products / Blog
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