Probiotics in Pakistan: DRAP rules

Live micro-organisms sold for a health benefit, as capsules, sachets, drops or powders.

What counts

The 2014 Enlistment Rules define a probiotic as an ingredient or product containing micro-organisms that gives a health benefit to the person who takes it. In Pakistan probiotics are mostly sold as capsules, sachets and drops, often for children with diarrhoea or alongside antibiotics.

What S.R.O. 1688 changed

Probiotics were already named in the DRAP Act 2012 as a "health and OTC product (non-drug)" and in the 2014 Enlistment Rules. S.R.O. 1688(I)/2026 now notifies them as therapeutic goods, so the DRAP rules for therapeutic goods, including the 2025 Advertisement Rules, clearly apply to them.

Who regulates it

DRAP Division of Health & OTC Products, under the Alternative Medicines and Health Products (Enlistment) Rules, 2014.

What companies should do

• 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).
• A claim that a probiotic reduces the risk of, or treats, a disease needs a Form 4 enlistment, which requires a full review of quality, safety and efficacy data.

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.

Other health and OTC product types

DisinfectantsNutritional productsFood supplementsSpecialised baby milk for medical conditionsMedicated cosmeticsMedicated soapsMedicated shampoos

Sources

1. DRAP: Notification of Health and OTC Products as Therapeutic Goods, S.R.O. 1688(I)/2026, 6 October 2026
2. Drug Regulatory Authority of Pakistan Act, 2012 (as amended till February 2022), sections 2(xv), 2(xxxvi) and 4
3. Alternative Medicines and Health Products (Enlistment) Rules, 2014, S.R.O. 412(I)/2014
4. Therapeutic Goods (Advertisement) Rules, 2025 (27 January 2025)

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.