PS 5453/2020: Pakistan's standard for hand sanitizer
PS 5453/2020 is the Pakistan Standard for Hand Sanitizer and Disinfectants, issued by the Pakistan Standards and Quality Control Authority (PSQCA). It sets requirements and test methods for alcohol-based instant hand sanitizers and for disinfectants, and PSQCA says it was developed in line with WHO guidelines.
Last reviewed by the SANITIZER.PK team
Quick answer
- Publisher: Pakistan Standards and Quality Control Authority (PSQCA).
- Scope: alcohol-based instant hand sanitizers (liquid or gel) and disinfectants. Non-alcohol sanitizers are not covered.
- Label: contents with percentages, manufacturing and expiry dates, batch number and manufacturer's name.
- Includes a laboratory method for measuring the percentage of ethyl alcohol.
What does PS 5453 cover?
The standard prescribes requirements and methods of test for alcohol-based instant hand sanitizers, and also requirements for disinfectants. It states that it does not cover non-alcohol based hand sanitizers.
Among its general requirements, the sanitizer should be a liquid or gel and should not have a disagreeable smell. It sets purity requirements for ingredients and includes reference formulations with alcohol, glycerol and hydrogen peroxide in line with the WHO approach.
What must be printed on the label?
PSQCA has informed manufacturers and distributors that, under PS 5453, the following must be legibly labelled on each bottle or pack:
| Label item | Why it matters to you |
|---|---|
| Contents with percentages | Lets you check the alcohol type and strength (at least 60% ethanol or 70% isopropyl alcohol) |
| Manufacturing and expiry dates | Alcohol evaporates over time; old stock may be weaker |
| Batch number | Links the bottle to a test report and lets a faulty batch be traced |
| Manufacturer's name | Someone accountable for the product |
- The contents of the product with their percentages.
- The dates of manufacturing and expiry.
- The batch number.
- The manufacturer's name.
How is alcohol content tested?
The standard includes an annex describing how to determine the percentage of ethyl alcohol: the sample is distilled and the specific gravity of the distillate is measured, which converts to percent alcohol by volume. Buyers do not need to repeat this, but a supplier should be able to show a result for the batch you are buying.
Who regulates hand sanitizers in Pakistan?
News reports from 2020 described the federal cabinet moving certification of hand sanitizers from the Drug Regulatory Authority of Pakistan (DRAP) to PSQCA. Regulatory arrangements can change, so for the current certification and licensing position, check directly with PSQCA.
A buyer's checklist based on PS 5453
- Read the label for alcohol type and percentage, batch number, dates and manufacturer.
- For bulk orders, ask for the test result for the batch you will receive, with the batch number on it.
- Check that the batch number on the delivered bottles matches the document.
- Reject products with no percentage, no batch number or no expiry date.
Sources and standards referred to
- Pakistan Standards and Quality Control Authority (PSQCA), PS 5453/2020 Pakistan Standard for Hand Sanitizer and Disinfectants.
- PSQCA notice to manufacturers and distributors on labelling under PS 5453 (reported by Business Recorder, 2020).
- World Health Organization, Guide to Local Production: WHO-recommended Handrub Formulations.
This guide is general information about hygiene products, not medical advice. For a health condition, speak to a doctor or pharmacist.
Frequently asked questions
Is PS 5453 compulsory?
PSQCA maintains a list of items that must comply with Pakistan Standards. Check PSQCA's current list or ask PSQCA directly for whether certification is compulsory for your product and use.
Does PS 5453 apply to alcohol-free sanitizers?
No. The standard states that it does not cover non-alcohol based hand sanitizers.
Where can I get a copy of PS 5453?
Pakistan Standards are published by PSQCA. Contact PSQCA or visit its website for official copies.
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