DRAP Orders One Validated Test for Iron Content in Iron Medicines in Pakistan
DRAP told labs and makers to test iron content in iron medicines with a validated method, naming Ferric Carboxymaltose. No failed brand is named. What to do.
DRAP has told its laboratories and drug makers that the iron content of iron medicines must be tested with one validated method, not only the method each manufacturer proposes. The notice names Ferric Carboxymaltose and Iron (III) Hydroxide Polymaltose Complex and does not say any iron product has failed. If you take iron for anaemia, you do not need to stop.
The Drug Regulatory Authority of Pakistan (DRAP) posted the notification on 21 September 2026. We read the DRAP page and its attached PDF on 21 October 2026. The PDF is a scan dated 11 September 2026 and signed for the Secretary of the Registration Board by a Deputy Director in the Division of Pharmaceutical Evaluation and Registration.
DRAP wants one validated way to measure iron in iron medicines
The notification says a uniform, validated and scientifically robust method should be set up to measure iron in these products. Today, many are checked with manufacturer-specific methods, including titration. DRAP says that can give inconsistent results between makers and labs.
Titration is a lab method where a liquid is added drop by drop until a colour change shows the end point. DRAP lists its weak points as lower precision, errors that depend on the analyst, and different readings of the end point.
| Point in the notification | What it says |
|---|---|
| Who decided | The Registration Board, at its 358th meeting on 12 May 2026 |
| Products named | Ferric Carboxymaltose and Iron (III) Hydroxide Polymaltose Complex, as examples of non-pharmacopoeial iron products |
| Why it matters | Iron products are used by high-risk patients, including pregnant women and elderly people with iron-deficiency anaemia |
| What must change | Registration holders and drug testing labs must use a validated method for iron content |
| What is not allowed | Testing iron content only by the method the manufacturer submitted or proposed |
Non-pharmacopoeial means no official standard method exists
A pharmacopoeia is an official book of quality standards and test methods for medicines. A non-pharmacopoeial product is one without a method in such a book. DRAP says a significant number of iron products on the market fall in this group, so labs have had no common yardstick.
The Board's advice is that any method must be validated, which means shown to work reliably for its purpose. DRAP stresses this where no pharmacopoeial method is available. That is why the notice reaches every lab that tests drugs, not just one.
The notice went to makers, chemists and every public drug laboratory
The distribution list includes the Pakistan Pharmaceutical Manufacturers' Association, the Pharma Bureau and the Pakistan Chemist and Druggist Association. It also lists the Central Drug Laboratory in Karachi and the provincial and regional drug testing laboratories, including Lahore, Faisalabad, Bahawalpur, Multan, Rawalpindi, Peshawar, Quetta, Karachi, Mirpur and Gilgit-Baltistan.
DRAP's offices in Karachi, Lahore, Islamabad, Peshawar and Quetta were asked to pass it to pharmaceutical units in their areas. The notice carries no deadline and no penalty. It is a direction to adopt validated methods, not an announcement of action against a named company.
Nothing in the notification tells patients to stop their iron
The notification contains no recall, no batch number and no warning about a brand. It does not say any tested product was short of iron. So a patient taking iron tablets, syrup or an injection should carry on as the doctor prescribed and not change the dose alone.
If you take iron in pregnancy or for long-standing anaemia, ask your doctor before changing brands. For help judging a pack, see how to check a medicine pack label against DRAP rules. Batch warnings, when DRAP issues them, are listed in our check for recalled medicine batches.
Report a problem with an iron product and keep the pack
If an iron medicine looks or tastes wrong, or you have a bad reaction, keep the pack and the receipt. Tell your doctor first. Then report it to DRAP or the National Pharmacovigilance Centre, which is the channel DRAP names in its safety alerts.
- Stop only if your doctor tells you to, and ask what to take instead.
- Photograph the pack, batch number and expiry date.
- Keep the receipt with the pharmacy name.
- Report the problem using the steps to report a medicine side effect to DRAP.
- Call DRAP's helpline on 0800-03727 if you need to know where to send it.
For fake packs rather than quality testing, DRAP's recent alert on four spurious batches shows how a named-batch warning looks. The iron notification is not of that kind.
Common questions about DRAP's iron testing notification
Are iron tablets or injections unsafe in Pakistan?
The notification does not say so. It names no unsafe brand or batch and asks for better, uniform testing of iron content.
Which iron products are named?
Ferric Carboxymaltose and Iron (III) Hydroxide Polymaltose Complex. DRAP uses them as examples of non-pharmacopoeial iron preparations.
Who has to follow the notification?
Registration holders and the drug testing laboratories, including the Central Drug Laboratory. It was sent to industry bodies for compliance.
When was the Registration Board decision made?
At the 358th meeting on 12 May 2026. DRAP circulated the decision in a notification dated 11 September 2026 and posted it online on 21 September.
Should pregnant women stop taking iron?
No. Nothing in the notice says so. Keep taking iron as prescribed and speak to your doctor about any worry.
Does the notice set a penalty?
No penalty or deadline appears in the PDF we read. It directs laboratories and registration holders to use validated methods.
How we verified this
What we checked, where we read it, and what we could not confirm.
Last checked 21 October 2026. We read DRAP's page and the attached "Iron testing" PDF, a scanned file with a faint date, which gave us the Board meeting, the products named, the reasons, the direction and the distribution list. We found no recall, batch alert or test result for any iron brand on DRAP's pages. We did not test any product and could not confirm whether any lab has already changed its method.
About the author
Tax, Bills and Technology Writer
Ali Akhtar is a young and curious voice here at Pakistan Era. He is currently pursuing his A-Levels and has a growing interest in Pakistan’s changing industrial landscape and educational trends. Ali likes to write in a way that helps him explain and explore the world around him. His writing reflects the perspective of the new generation navigating the evolving trends of Pakistan where technology, youth innovation, and shifting opportunities are reshaping the country’s future.
