WHO Prequalification Programme

WHO prequalification is a quality check run by the World Health Organization on vaccines, medicines, diagnostic tests and some medical devices. When a product passes, WHO puts it on its official list of "prequalified" products. This tells UN agencies and many low- and middle-income countries that the product is safe, effective and made to good quality standards, so they can buy it with confidence.

Why does it exist?

Many poorer countries do not have a strong drug regulator that can test every vaccine or medicine on its own. UN agencies like UNICEF also buy huge quantities of vaccines for children around the world, and they need a reliable way to know a product is good. Prequalification solves both problems. Think of it like a trusted quality stamp on a product: a buyer who cannot check everything personally relies on the stamp.

Where did it come from?

• 1987: WHO started prequalifying vaccines, as a service to the Supply Division of UNICEF.
• 2001: Prequalification of medicines began, first for HIV/AIDS, malaria and tuberculosis.
• Later it was extended to in vitro diagnostics (lab tests), immunisation devices, and some medical devices.

How does it work?

Step by step:

1. The manufacturer's own country regulator must first approve the product. For vaccines, that National Regulatory Authority (NRA) must itself be rated functional by the WHO. A company cannot apply if its home regulator is not up to the mark.
2. The company submits a detailed file (dossier) with data on quality, safety and effectiveness.
3. WHO experts review the data and test samples.
4. WHO inspects the manufacturing site to check it follows Good Manufacturing Practices (GMP).
5. If all is in order, the product is added to the prequalified list. WHO keeps monitoring it, with re-checks and follow-up of any safety problems.

A faster abridged route exists for products already approved by trusted regulators. WHO charges fees for assessment. For example, a full assessment of an in vitro diagnostic costs USD 18,700 per product in 2026.

India's regulator and the NRA rating

India's NRA for vaccines is the Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI), working with state regulators and other bodies. WHO checks NRAs using its Global Benchmarking Tool (GBT), which rates them from Maturity Level 1 (weakest) to 4 (best). After a re-benchmarking in September 2024, the WHO declared India's vaccine regulatory system functional at Maturity Level 3. This rating is what allows Indian vaccine makers to apply for prequalification.

Why does it matter for India?

India is often called the "pharmacy of the world". Indian companies, especially the Serum Institute of India (the world's largest vaccine maker by number of doses), supply a large share of vaccines bought by UNICEF and Gavi, the Vaccine Alliance. Each prequalification opens up global markets, earns export income and strengthens India's health diplomacy. Cervavac is SII's 32nd prequalified product.

Commonly confused concepts

• Prequalification vs Emergency Use Listing (EUL): Prequalification is a full, long-term approval for routine use. EUL is a faster, time-limited listing for products used during a public health emergency, when data are still limited. For example, India's Covaxin got WHO EUL in November 2021 during COVID-19.
• Prequalification vs national approval: National approval (by the DCGI in India) lets a product be sold in that country. Prequalification is WHO's international quality check for UN buying.
• Prequalification vs WHO Listed Authority (WLA): Prequalification is about a single product. WLA status is about a whole country's regulator, meaning WHO trusts its decisions fully.
• WHO vs UNICEF vs Gavi: WHO sets standards and prequalifies. UNICEF buys and delivers vaccines. Gavi (founded 2000) funds vaccines for lower-income countries.

Issues, criticism and the way forward

• Time and cost: Prequalification can take a long time and is costly for small manufacturers. WHO has introduced abridged routes and reliance on trusted regulators to speed things up.
• Concentration of suppliers: For some vaccines, only a few makers are prequalified, so a problem at one plant can cause global shortages. More prequalified makers, like Cervavac for HPV, reduce this risk.
• Regulatory strength at home: Quality incidents involving some Indian-made medicines exported abroad have raised concerns. Experts stress stronger GMP enforcement by CDSCO and state regulators so that global trust in Indian products holds.

Concepts to Know

• National Regulatory Authority (NRA): A country's official body that approves and monitors medicines and vaccines. In India it is CDSCO.
• Good Manufacturing Practices (GMP): Rules for how factories must make medicines so that every batch is safe and of the same quality.
• Dossier: A full file of scientific data a company submits to get a product approved.
• In vitro diagnostics: Tests done on samples like blood or swabs outside the body, such as an HIV test kit.
• Gavi, the Vaccine Alliance: A global partnership, set up in 2000, that helps poorer countries buy vaccines.