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Most people who ask us about "DRAP approval" for a face cream do not need it. Some people who never think to ask do. The difference is not the product category — it is what is inside the formula and what the label promises, and getting that judgement right at the start saves months later.
This is a plain-English walk through how the system actually works, written from the DRAP Act 2012, the Alternative Medicines and Health Products (Enlistment) Rules 2014, and the fee schedule that took effect on 1 August 2025. Where the rules are ambiguous, we say so rather than smoothing it over.
First: PSQCA or DRAP?
Pakistan splits cosmetic-type products between two regulators, and the boundary is drawn by the formula and the claim, not by the shelf it sits on.
A moisturiser, cleanser, serum or sunscreen that contains no drug substance and makes only cosmetic claims falls under the Pakistan Standards and Quality Control Authority. Several categories — skin cream, shampoo, toilet soap, toothpaste, hair dye, shaving cream, skin powder and hair cream among them — are on PSQCA's compulsory items list, which means they must meet the relevant Pakistan Standard. For skin creams that standard is PS 3228, and it is not decorative: it sets limits on pH, microbial count, heavy metals, mercury and arsenic, requires the absence of hydroquinone and corticosteroids, and prescribes what the label must carry.
The moment a formula contains a drug substance, or the label claims to treat a condition, the product moves under the Drug Regulatory Authority of Pakistan. Natural-ingredient medicated cosmetics, derma-care products and oral supplements are enlisted with DRAP's Health and OTC Products Division. Cosmetics containing drugs listed in Schedule-1 of the DRAP Act — hydroquinone and corticosteroids are the ones brand owners ask about most — are a drug registration matter entirely, which is a longer and more demanding route.
What "enlistment" actually means
Enlistment is not registration, and the distinction matters when you are writing marketing copy. Under rule 2 of the 2014 Rules, enlistment is a provisional number in DRAP's register that grants temporary manufacturing and marketing authorisation until fuller licensing rules are enacted. It is renewable — the 2025 schedule prices renewal at half the initial fee — and it can be revoked for non-compliance.
That is why the correct phrase is "DRAP enlisted", and why you should be cautious about any supplier who tells you their products are "DRAP approved" or "DRAP registered". Those words describe something else.
Who holds the enlistment: you, or the manufacturer?
This is the question every clinic owner asks, and it is the one with the least tidy answer.
On paper, the Rules contemplate both. Rule 2 defines a "contract giver" — the person who awards the contract for products under their own brand — and a "contract acceptor", the manufacturer producing the finished product under the contract giver's label. Rule 3(2) lists a contract giver among those who may apply, and Form 1 covers enlistment as a manufacturer or a contract giver.
In practice, two details point the other way. Form 8, the contract-manufacturing certificate, is approved for one year and carries a condition that the enlistment holder has undertaken to establish their own manufacturing facility. And the August 2025 fee schedule prices firm enlistment for contract manufacturing with the parenthetical "manufacturer to manufacturer only".
Read together, those suggest DRAP currently treats contract manufacturing as an arrangement between two manufacturers rather than a route for a brand owner with no plant. So the structure most doctor-led brands use is the other one: the enlisted manufacturer holds the product enlistment under the doctor's brand name, the doctor registers the trademark with IPO Pakistan in their own name, and a private-label agreement records that the brand — and, where agreed, the formula — belongs to the doctor.
That is a commercial structure, not a workaround. You still own the thing that matters: the name your patients recognise. But it is worth confirming the route for your specific products with the Health and OTC Division before anyone tells you the enlistment will be in your company's name.
The documents DRAP actually asks for
Product enlistment for a locally manufactured product is filed on Form 3 where the claims are general health, traditional use, nutritional or structure-function. Form 4 applies where the claim is therapeutic or disease-reducing, and it asks for more evidence. Between them they call for:
- The product profile: brand name, ingredients with strengths, common names, recommended use, pack size and proposed retail price
- The master formula and the manufacturing process
- Testing specifications for raw materials and the finished product
- Shelf life, storage conditions and recommended conditions of use
- Packaging and labelling artwork
- A notarised undertaking that the contents of the application are true
- The fee receipt from DRAP's online challan system
Almost all of that is manufacturer-side paperwork. If your manufacturer produces the master formula, the specifications, the stability data and the label artwork as part of development — rather than scrambling for them once you ask — the file is ready the day you approve your sample. If they do not, you will discover the gap at the worst possible moment.
What the brand owner supplies is much shorter: identity and business documents (CNIC, company or partnership registration, NTN), the trademark application or certificate, the signed private-label and quality agreement that rule 3(3)(g) requires, and the notarised undertaking.
What it costs
Government fees are published and, by the standards of launching a brand, modest. Under S.R.O. 1399(I)/2025, effective 1 August 2025, the Health and OTC lines include:
- Enlistment of a locally manufactured health product — Rs 6,300
- Enlistment as a local manufacturer — Rs 19,900
- Firm enlistment for contract manufacturing, or a change of contract giver — Rs 19,900
- Product fee for contract manufacturing — Rs 6,300 per category, or Rs 12,500 for more than ten products
- Miscellaneous variations, such as an extra pack size or a specification change — Rs 3,100
- GMP certificate for therapeutic goods, per annum — Rs 26,100
- Renewal of a manufacturing or product enlistment — half the initial fee
One line in that schedule is worth reading twice: fees deposited for any regulatory service are not refundable. A file that is wrong is not a free retry.
PSQCA fees, laboratory testing and Halal certification are separate, and none of them are the expensive part of a launch. Product development, packaging and stock are.
How long it takes, honestly
DRAP publishes no statutory timeline for product enlistment. Applications are processed first come, first served, and DRAP publishes the queue by year, so you can see roughly where files sit.
Anyone who quotes you a fixed number of weeks for enlistment is guessing. Plan for several months, and structure the project so nothing is waiting on it: formulation, sampling, patient trials, artwork and print proofs can all run while a file sits in the queue. The brands that feel delayed by DRAP are usually the ones that started the paperwork last.
Two things people forget
The first is advertising. Rule 11 requires DRAP to review advertising material for enlisted products before it runs. If your launch plan includes paid promotion on the day stock lands, that review needs to be in the plan too.
The second is that enlistment is a live obligation, not a certificate to frame. Rule 8 makes the enlistment holder liable for quality, safety and efficacy, requires release only after certification by an authorised person, and requires records to be kept for a year past product expiry. Enlistments and GMP certificates are time-limited and renewable, and a new pack size or a new claim can need a variation filing.
Where to start
Start with classification, before formulation. Decide, product by product, whether you are on the PSQCA route or the DRAP route, because that decision shapes the formula, the claim, the label and the file. Changing your mind after development is what turns a three-month launch into a nine-month one.
If you would like us to classify a product list for you, send it over. We will tell you which route each product takes, what the file needs, and what we produce versus what you supply.
