DRAP S.R.O. 1688(I)/2026: health and OTC products are now therapeutic goods. What it means

On 6 October 2026 the Drug Regulatory Authority of Pakistan (DRAP) notified eight kinds of health and OTC products as "therapeutic goods". Here is what changed, who it affects and what companies, pharmacies, hospital buyers and the public should do now.

Updated 14 October 2026

In short

DRAP used its power under section 2(xxxvi) of the DRAP Act 2012, on the recommendation of its Policy Board.
The eight products were already listed in the DRAP Act as "health and OTC products (non-drugs)". They are now clearly "therapeutic goods", the term DRAP's laws use for the products it controls.
The practical effect: DRAP enlistment for firms and products, and DRAP approval before any advertisement, apply clearly to all eight.

The eight products notified

Probiotics: Live micro-organisms sold for a health benefit, as capsules, sachets, drops or powders.
Disinfectants: Products that kill germs on skin, surfaces or equipment, such as hand sanitisers and hospital disinfectants.
Nutritional products: Products that supply nutrition, such as protein powders, oral nutrition drinks and fortified formulas.
Food supplements: Vitamins, minerals and other supplements sold as tablets, capsules, sachets, syrups or drops.
Specialised baby milk for medical conditions: Infant formulas made for babies with medical needs, such as lactose-free, hypoallergenic or preterm formulas.
Medicated cosmetics: Creams, lotions and other cosmetics that contain an active ingredient for a skin or hair problem.
Medicated soaps: Soaps with an antiseptic or other active ingredient sold for a skin problem or germ protection.
Medicated shampoos: Shampoos with an active ingredient for dandruff, lice, fungal or other scalp problems.

What changes in practice

1. Enlistment with DRAP

Under the Alternative Medicines and Health Products (Enlistment) Rules, 2014, firms (manufacturers and importers) and their products must be enlisted with DRAP's Division of Health and OTC Products. Medicated cosmetics fall under DRAP's Division of Medical Devices and Medicated Cosmetics.

2. Advertising needs DRAP approval first

Under the Therapeutic Goods (Advertisement) Rules, 2025, an advertisement of a health and OTC product needs prior written approval from DRAP's Advertisement Board. Each advertisement and each product needs its own application, and an approval is valid for two years. Claims about diseases listed in the rules (such as cancer, diabetes and heart disease) are not allowed.

3. Quality and claims

Product labels may not claim to treat or cure a disease unless DRAP has approved that claim after reviewing quality, safety and efficacy data.

Timeline

2012	DRAP Act lists probiotics, disinfectants, nutritional products, food supplements, baby milk, medicated cosmetics, soaps and shampoos as health and OTC products (non-drugs). Source
May 2014	Alternative Medicines and Health Products (Enlistment) Rules set up enlistment of firms and products. Source
Jan 2025	Therapeutic Goods (Advertisement) Rules: advertisements need prior written approval of DRAP's Advertisement Board. Source
Feb 2026	DRAP warns pharmaceutical and nutraceutical companies about unapproved advertisements, including on social media (news report). Source
1 Oct 2026	DRAP revises its regulatory fees for therapeutic goods (S.R.O. 1660(I)/2026). Source
6 Oct 2026	S.R.O. 1688(I)/2026 notifies the eight health and OTC products as therapeutic goods (published on DRAP's website on 13 October 2026). Source

What to do now

Companies (manufacturers and importers)

Check that your firm (manufacturer or importer) is enlisted with DRAP and that each product is enlisted. Under the 2014 Enlistment Rules a manufacturer applies on Form 1, an importer on Form 2, and products on Form 3 (general or nutritional claims), Form 4 (disease-reduction or therapeutic claims) or Form 5 (imported products).
Do not run any advertisement, including on Facebook, YouTube, TikTok or WhatsApp, until DRAP's Advertisement Board has given written approval for that advertisement. One application is needed for each advertisement and each product, and an approval is valid for two years.
Remove claims that a product treats or cures a disease unless DRAP has approved that claim. Advertisements may not compare with other products, call a product "the most effective", or encourage self-medication.
Watch DRAP for a notice on timelines and fees. DRAP revised its regulatory fees for therapeutic goods on 1 October 2026 (S.R.O. 1660(I)/2026).

Pharmacies, hospital buyers and the public

Pharmacies and distributors: buy from firms that can show their DRAP enlistment, and keep invoices that name the firm.
Hospital and public-sector buyers: ask bidders for the DRAP enlistment (or registration) of the firm and the product in the tender.
Public: a supplement or medicated product is not a replacement for medicine your doctor prescribed. Be careful with products that claim to cure diseases such as diabetes or cancer; DRAP does not allow such advertising.

Still unclear: DRAP has not yet said (as of 14 October 2026) whether there is a transition period, or whether existing provisional enlistments simply continue. We will update this page when DRAP publishes guidance.

Common questions

Does this mean these products are now medicines?

No. They remain health and OTC products, not prescription medicines. The notification places them within "therapeutic goods", so DRAP's rules on enlistment, quality and advertising clearly apply.

Do supplement companies need approval to advertise?

Yes. Under the Therapeutic Goods (Advertisement) Rules, 2025, advertisements of health and OTC products need prior written approval from DRAP's Advertisement Board, and each approval is valid for two years.

Are ordinary cosmetics, soaps and shampoos covered?

No. Only medicated cosmetics, medicated soaps and medicated shampoos are named, meaning products with an active ingredient for a health purpose.

Is ordinary infant formula covered?

The notification names "specialised baby milk for medical conditions". Ordinary infant formula is not named in it.

Is there a deadline for companies?

DRAP has not published a deadline or transition period yet (as of 14 October 2026). Follow DRAP's notices; we will update this page.

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Sources

Prepared by the MedInfoBase team of pharmacists, physicians and academics. Last checked 14 October 2026. This page explains public DRAP documents in plain English; it is not legal advice. Always check DRAP's official notices before acting.