DRAP Says S.R.O. 1688 Adds No New Category: Probiotics, Supplements and Medicated Soaps Stay Non-Drugs
DRAP says S.R.O. 1688 adds no new category: probiotics, supplements and medicated soaps stay Health and OTC products. See all 8 types and what to check.
DRAP says S.R.O. 1688 of 6 October 2026 does not bring any new product category under its control. Probiotics, supplements, medicated soaps and five other product types were already regulated as Health and OTC products, and they stay that way, under a clarification dated 2 November 2026. DRAP posted it on 5 November.
When the Drug Regulatory Authority of Pakistan (DRAP) named eight product types as "therapeutic goods" in October, the question was simple: are probiotics and medicated shampoos now treated like medicines? We could not answer that in October, when the notification appeared, because DRAP had not explained it. Now it has, in one short letter. We read the signed copy, No. F.11-1/2026-LA, on 7 November 2026.
DRAP says the October notification adds no new category
The clarification has one main point. DRAP says the notification "does not bring any new product category within the regulatory ambit of the Authority". Regulatory ambit means the area a regulator controls. These products were inside it already, DRAP says, so nothing was added.
DRAP also gives its reason for issuing the notification at all. It says the aim was to "foster an enabling regulatory environment for legitimate manufacturers". In plain words, it is presented as a help to lawful companies, not a new burden on them. The letter does not explain how it helps them.
Eight product types stay with DRAP's Health and OTC divisions
The eight product types remain under the DRAP divisions already responsible for them, under section 4(1) of the DRAP Act 2012 and its rules. DRAP calls them Health and OTC products, and it says they are non-drugs. OTC means over the counter, or sold without a prescription.
| No. | Product type | Everyday example |
|---|---|---|
| 1 | Probiotics | Sachets or capsules of live bacteria |
| 2 | Disinfectants | Surface and skin disinfectants |
| 3 | Nutritional products | Nutrition drinks and powders |
| 4 | Food supplements in pharmaceutical dosage forms | Vitamin tablets and capsules |
| 5 | Specialised baby milk for medical conditions | Milk prescribed for a baby's condition |
| 6 | Medicated cosmetics | Skin creams with a medicinal claim |
| 7 | Medicated soaps | Soaps sold with a medicinal claim |
| 8 | Medicated shampoos | Shampoos sold with a medicinal claim |
The left two columns are from DRAP's letter. The examples are ours, to help you picture each type. DRAP's letter does not list examples, so do not treat that column as a legal list.
Three sections of the DRAP Act carry the argument
DRAP's letter rests on three provisions of the DRAP Act 2012. Section 2(xxxvi) lets it declare a product a therapeutic good. Section 2(xv) already defines Health and OTC products. Section 4(1) gives its divisions their duties.
| Section | What DRAP's letter says it does |
|---|---|
| 2(xxxvi) | Lets the Authority notify and declare any product as a therapeutic good, for regulation under the Act |
| 2(xv) | Already defines Health and OTC products (non-drugs) |
| 4(1) | Sets the statutory mandate of DRAP's divisions, which keep regulating these products |
This is DRAP's own reading of its Act. We have set it out as DRAP states it. A court could read the Act differently if a company ever challenged it, but nothing we have seen suggests that has happened.
Buyers should keep checking the pack in the same way
Nothing on the shelf changes because of this letter. You do not need a prescription for a food supplement because of it, and it says nothing about old stock. The checks you should make before buying stay the same.
- Look on the pack for the maker's or importer's name and address. A product with neither is a warning sign.
- Check whether a health product is enlisted. Checking a herbal or health product with DRAP depends on the enlistment rules.
- Read the batch number and expiry date, and keep your receipt.
- Be wary of products sold only on social media with no address.
- If a product looks fake or hurts someone, report it. Side effects go through DRAP's side effect form.
The word that matters here is "enlisted". Herbal, Unani, homeopathic and health products are enlisted with DRAP under 2014 rules. Medicines are registered, which is a different process. A probiotic with an enlistment number is not the same as a tablet with a registration number, and it should not be sold as if it were.
Seven trade bodies received DRAP's letter
DRAP addressed the clarification to six trade associations and one pharma industry body. They include nutraceutical, tibbi, homoeopathic, healthcare device, veterinary and pharmaceutical manufacturers. A company with a product in these eight types should ask its association for the latest position.
We should be clear about the limits. The letter answers one question: whether this is a new category. It does not answer whether any of the eight types will face new licensing steps, fees or labelling later. It also does not tell us the Gazette date of the October notification, which we still could not confirm. DRAP's phrase "the rules framed thereunder" means the existing rules continue, and the letter names no new rule. If that changes, we will update this page.
Common questions
Did DRAP make probiotics a medicine?
No, on DRAP's own account. It calls them Health and OTC products, which it describes as non-drugs, declared therapeutic goods for regulation under the Act.
What does S.R.O. 1688 of 2026 do, according to DRAP?
It names eight product types as therapeutic goods. DRAP says it does not bring in any new category, because those products were already defined and regulated.
Do I need a prescription for vitamins or a food supplement now?
Neither the notification nor the clarification says so. Neither one mentions prescriptions.
Do makers need to apply again because of this?
The letter does not ask for any new application. It says the products remain subject to the respective DRAP divisions and the existing rules.
When was the clarification issued?
It is dated 2 November 2026 and carries the number F.11-1/2026-LA. DRAP's website shows it posted on 5 November.
Does this change the price of these products?
The letter does not mention prices at all.
How we verified this
What we checked, where we read it, and what we could not confirm.
Last checked on 7 November 2026. We read the signed scan of DRAP's clarification and compared it with the October notification on DRAP's website.
About the author
Public Services and Education Journalist
Fajr Riaz is a journalist and content writer at Pakistan Era, based in Lahore. She covers the questions people meet in everyday life in Pakistan: how a public service works, what a change in the rules means, and where to find a reliable answer.
