From CPHI India 2014

Do you manufacture these APIs? ‘We’re interested in you,’ says WHO

By Fiona BARRY

- Last updated on GMT

The WHO's Anthony Fake spoke at CPHI India in Mumbai this week.
The WHO's Anthony Fake spoke at CPHI India in Mumbai this week.

Related tags Pharmaceutical drug Pharmacology Fake

The World Health Organisation says its prequalification scheme gives free help to makers of selected APIs, drugs and vaccines who want to boost their standards and access international markets.

Two separate programmes, one for APIs (active pharmaceutical ingredients) and another for FPPs (finished pharmaceutical products) aim to help procure quality drugs and vaccines for aid organisations but also find international buyers for domestic outfits, according to the WHO’s Anthony Fake.

Speaking at CPHI India this week, Fake said the schemes were set up because of UN concern at nonexistent quality assurance in international procurement of medicines and ingredients for neglected indications. The programmes only apply to specific APIs and drugs related to HIV, Hepatitis B and C, tuberculosis, reproductive health, influenza, zinc, and some tropical diseases.

Such drugs are often made in unregulated countries and provided to unregulated regions, he said, and are not “mainstream​” products registered with SRAs (Stringent Regulatory Authorities – usually considered to be EU or EFTA member states, Japan and the US).

API manufacture

Under the API prequalification scheme, the WHO verifies the quality of an API through a drug master file statement and by looking at the quality of the manufacturing facility.

Fake said the programme aims to bridge what can be a big barrier between drug- and API-makers in the area of scarce APIs. “Finding a good API supplier is not like looking up the phone book, particularly in the areas of HIV and TB.​”

The programme mainly attracts producers in Africa, Eastern Europe, India, China, and South America who have good domestic experience but have sold little internationally.

It’s an opportunity to be publicly recognized. This might be the first time they have seriously considered SRA-type assistance to refine their manufacturing practice standards.​”

Fake said in recent months the scheme has been increasingly recognized by national regulators – especially in the East African Community, Malaysia, South Africa, and Zimbabwe.

If you don’t have a CPD [Capability Product Document], this is the next best thing.​”

He added that with South Africa set to introduce drug master files, a prequalified API could become a way of addressing regulators’ needs without exposing sensitive commercial information.

API manufacturers are not required to have an associated drug product to qualify for the scheme.

Qualifying APIs

If you’re a manufacturer of one of these APIs, we’re interested in you, and we hope you’re interested in us​” – the WHO’s latest invitation for Expressions of Interest calls on manufacturers of the following ingredients:


Therapeutic Area

Invited Active Pharmaceutical Ingredient

HIV, Hepatitis B and C

 Abacavir
 Atazanavir
 Darunavir
 Dolutegravir
 Efavirenz
 Emtricitabine
 Entecavir
 Etravirine
 Lamivudine
 Lopinavir
 Nevirapine
 Raltegravir
 Ribavirin
 Rifabutin
 Ritonavir
 Simeprevir
 Sofosbuvir
 Stavudine
 Tenofovir
 Valgancyclcovir
 Zidovudine


 Amodiaquine
 Artemether
 Artesunate
 Dihydroartemisinin
 Lumefantrine
 Mefloquine
 Piperaquine
 Pyrimethamine
 Pyronaridine
 Sulfadoxine


 Amikacin
 Capreomycin
 Clofazimine
 Cycloserine
 Ethambutol
 Ethionamide
 Isoniazid
 Kanamycin
 Levofloxacin
 Linezolid
 Moxifloxacin
 Para-Aminosalicylic Acid (PAS)
 Para-Aminosalicylate sodium (PAS Sodium)
 Prothionamide
 Pyrazinamide
 Rifampicin
 Streptomycin
 Terizidone

Reproductive health

 Desogestrel
 Estradiol cypionate
 Estradiol valerate
 Ethinylestradiol
 Etonogestrel
 Levonorgestrel
 Medroxyprogesterone acetate
 Mifepristone
 Misoprostol
 Norethisterone enanthate
 Norgestrel
 Oxytocin

Neglected tropical diseases

 Albendazole
 Diethylcarbamazine citrate
 Mebendazole
 Praziquantel


 Zinc sulfate


 Oseltamivir
 Zanamivir


As for the WHO drug scheme, Fake says it has so far qualified 400 finished medicines.

UN drug procurers can accept tenders only from SRA regions or from the WHO’s programme – meaning prequalification opens up API makers’ access to other markets.

Fake stressed that the platform brings indirect benefits as well, as the WHO provides free external consultants to advise the companies on improving their standards, especially around GMP dossier compilation.

With improved quality compliance, these drugmakers are free to sell to other buyers besides the UN, which Fake said the WHO has no problem with.

A recently launched Collaborative Project involving 25 African and Eastern European nations puts those countries in contact with prequalified companies with a view to doing business. “In terms of entering non-UN markets this is important as waiting times for approvals in these regions can be 2 or 3 years, so this is an accelerated opportunity,​” said Fake.

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