Specialised baby milk for medical conditions in Pakistan: DRAP rules

Infant formulas made for babies with medical needs, such as lactose-free, hypoallergenic or preterm formulas.

What counts

These are formulas for infants with medical conditions, for example cow's milk protein allergy, lactose intolerance, prematurity or metabolic disorders. The 2014 Enlistment Rules include formulae for special medical purposes for infants and young children within "baby milk and foods".

What S.R.O. 1688 changed

The DRAP Act lists "baby milk and foods" as health and OTC products. S.R.O. 1688(I)/2026 notifies specialised baby milk for medical conditions as therapeutic goods. Ordinary infant formula is not named in the notification.

Who regulates it

DRAP Division of Health & OTC Products, under the 2014 Enlistment Rules.

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).
• Breastfeeding is the best food for babies. Specialised formula should be used on the advice of a doctor.

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

ProbioticsDisinfectantsNutritional productsFood supplementsMedicated 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.