FIJI PHARMACEUTICAL PROFILE

Rahul Yadav

Marketing & Operation/Tender supply - Export Formulation at IPCA Laboratories Ltd

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September 29, 2021
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 Capital City: Suva

 Drug Authority: FPBS (Fiji Pharmaceuticals and Biomedical Services Centre)
 Web: https://www.health.gov.fj/
 Official languages: Fijian English & Fiji Hindi
 Currency: Fijian dollar (FJD)

Demographics and Socioeconomic Indicators:

The total population of Fiji in 2009 was 849,000 with an annual population

growth rate of 0.6%. The annual Gross Domestic Product (GDP) growth

rate is -2.50%. The GDP per capita was US$ 3,574.12 (at the current

exchange ratei).

FIJI ISLAND:

Fiji consists of an archipelago of more than 330 islands—of which about 110 are
permanently inhabited—and more than 500 islets, amounting to a total land area of
about 18,300 square kilometres.

Health Expenditures:

In Fiji, the total health expenditure (THE) in 2008 was FJ$ 205.8 million

(US$ 105 million). The total health expenditure was 3.46% of the GDP,

equivalent to FJ$ 242.40 (US$ 123.67) per capita (Review of

Pharmaceutical Financing and Expenditure in Selected PICs, 2005; Fiji

Health Accounts, 2008).

Top Pharma Companies in Fiji:

  Alphamed.
 B. Budget Pharmacy Wholeslae.
 E. Excel Distributors Pte Limited.
 H. Healthcare Products International.
 MAKANS.
 Nausori Pharmacy.
 Pharmatec. Pharmatec Ltd.
 R. Ray Pharmaceauticals.

Manufacturing:

There is one licensed pharmaceutical manufacturer in Fiji. Manufacturing

capabilities are presented in Table 4 below. This manufacturer is a foreign owned

company. It produces only for export, so the share of the local

market is zero.

Manufacturing capabilities

1. Research and Development for discovering new active substances - No

2. Production of pharmaceutical starting materials (APIs) - No
3. The production of formulations from pharmaceutical starting material - Yes
4. The repackaging of finished dosage forms - Yes

Regulatory Framework:

In Fiji, there are legal provisions establishing the powers and

responsibilities of the Medicines Regulatory Authority (MRA). The MRA is a

part of the Fiji Pharmaceuticals and Biomedical Services Centre, Ministry

of Health with a number of functions outlined as per below:

Marketing Authorization (Registration):

In Fiji, there are now legal provisions that require marketing authorization

(registration) for all pharmaceutical products on the market. Other

regulatory functions (e.g. inspection) are also being undertaken by Fiji

Pharmaceutical and Biomedical Services Centre FPBSC). Since FPBSC is

the only importer for the public sector, they know what is imported in the

public sector. When importing for the public sector, FPBSC relies on

assessments done by other regulatory agencies because the capacity

does not exist for assessing applications for marketing authorization of

pharmaceutical products. Possession of a Certificate for Pharmaceutical

Products (that accords with the WHO Certification scheme) is required as

part of the Marketing Authorization application. The Medicinal Products

Decree 2011 provides legal provisions requiring the MRA to make the list

of registered pharmaceutical products publicly available and update it

regularly. Medicines are always registered by their International Nonproprietary

Names (INN) or Brand name + INN.

Regulatory Inspection:

In Fiji, legal provisions permitting inspectors to inspect premises where

pharmaceutical activities are performed exist. Such inspections are

required by law and are a pre-requisite for the licensing of private, but not

public, facilities. Where inspections are legal requirements, these are the

same for public and private facilities. Inspections are carried out on a

number of entities

Import Control:

Legal provisions requiring authorization to import medicines exist. Laws do

not exist that allow the sampling of imported products for testing. Legal

provisions requiring importation of medicines through authorized ports of

entry exist and Regulations or Laws to allow for inspection of imported

pharmaceutical products at authorized ports of entry also exist.

Licensing:

In Fiji, legal provisions requiring manufacturers to be licensed exist. Legal

provisions requiring manufacturers (both domestic and international) to

comply with Good Manufacturing Practices (GMP) also exist. Good

Manufacturing Practices are not published by the government but

international standards such as those accepted by the Therapeutic Goods

Administration (TGA), Australia are used as a reference point.

Legal provisions pertaining to licensing

Entity requiring licensing

Importers - Yes

Wholesalers - Yes

Distributors - Yes

Market Control and Quality Control:

In Fiji, legal provisions for controlling the pharmaceutical market exist. A

Quality Control Laboratory does not exist in Fiji. The regulatory authority

contracts services elsewhere. Samples are sent to TGA Laboratories,

Australia.

Reason for medicines testing

For quality monitoring in the public sector - Yes

For quality monitoring in the private sector - Yes

When there are complaints or problem reports - Yes

For product registration - No

For public procurement prequalification - No

For public program products prior to acceptance and/or distribution - No

Clinical Trials:

In Fiji, legal provisions exist requiring authorization for conducting Clinical

Trials. Applications for conducting clinical trials are dealt by the ethics

committee.

Pricing Regulation for the Private Sector:

In Fiji, there are legal or regulatory provisions affecting pricing of medicines.

These provisions are aimed at the level of wholesalers and retailers.

Duties and Taxes on Pharmaceuticals (Market):

Fiji imposes duties on imported active pharmaceutical ingredients (APIs)

and duties on imported finished products are also imposed.

Currently the Ministry of Health provides medicines free of charge and is

covering more than 70% of the population.

Public Sector Procurement:

Public sector procurement in Fiji is both centralized and decentralized. The

public sector procurement is centralized under the responsibility of a

procurement agency (Fiji Pharmaceuticals and Biomedical Services Centre)

which is a part of the Ministry of Health. Procurement is based on the

prequalification of suppliers.

Public sector procurement in Fiji is both centralized and decentralized. The

public sector procurement is centralized under the responsibility of a

procurement agency (Fiji Pharmaceuticals and Biomedical Services Centre)

which is a part of the Ministry of Health. Procurement is based on the

prequalification of suppliers.

Public Sector Distribution:

The government supply system department (Fiji Pharmaceuticals and

Biomedical Services Centre) in Fiji has a Central Medical Store (CMS) at

National Level. There is one public warehouse in the secondary tier of the

public sector distribution which is based at a Divisional Hospital. There are

no national guidelines on Good Distribution Practices (GDP).

Private Sector Distribution:

Legal provisions exist for licensing wholesalers and distributors in the

private sector. A list of GDP certified wholesalers and distributors exist in

the private sector.

Note- Above information is only based on public domain

Thank you

Rahul