Regulatory Affairs · Short notes

Pricing and Licensing: Short Notes & Cheat Sheet

Drug pricing under DRAP's pricing policy, essential and non-essential medicines, manufacturing licences and provincial sale licences.

Short notes

Read these before you attempt the topic's MCQs.

After the 18th Amendment, manufacturing, registration and pricing stayed federal while sale licensing is provincial.

The maximum retail price (MRP) of controlled-price medicines is fixed by the federal government on DRAP's recommendation and printed on the pack.
The Drug Pricing Policy 2018 divides medicines into essential and non-essential, and sets rules for pricing new products and for annual inflation-linked (CPI) adjustments.
In February 2024 the caretaker federal cabinet deregulated prices of medicines not on the National Essential Medicines List (SRO 228(I)/2024). Essential medicines remain price-controlled.
DRAP later reported that prices rose for more than half of the deregulated medicines.
Selling above the printed MRP is an offence.

Manufacturing licences are granted by DRAP's Central Licensing Board (handled by the Drug Licensing Division) after inspection of premises, equipment, staff and quality systems.
Five types: formulation (finished dosage forms), basic manufacturing (APIs or biological drug substance), semi-basic manufacturing, repacking (as specified in Schedule D) and experimental (investigational products for clinical trials).
Each licence lists approved sections (e.g. tablets, capsules, liquids, sterile, penicillin, cephalosporin).
Drug manufacturing licences are valid for 5 years unless revoked or suspended earlier; GMP compliance is checked by DRAP inspectors.

Retail and wholesale sale is licensed by the provinces under their own drug rules (e.g. the Punjab Drugs Rules 2007, Sindh Drugs Rules 2010).
A pharmacy is run under a registered pharmacist (Register A). A medical store may be run under a qualified pharmacy technician (Register B).
Distributors and wholesalers need their own licences and must keep proper storage and records.
Licences must be displayed and renewed, and the qualified person must actually be present.

High-yield facts in one place. Cover the right-hand column and test yourself.

Licence	Issued by
Manufacturing (5 types, valid 5 years)	Central Licensing Board, DRAP
Drug registration	Registration Board, DRAP
Retail pharmacy / medical store	Provincial licensing authority
Wholesale / distribution	Provincial licensing authority
Price (MRP) of controlled products	Federal government on DRAP advice

Outlet	Run under
Pharmacy	Registered pharmacist (Register A)
Medical store	Pharmacy technician (Register B)
Manufacturing (production, QC)	Qualified pharmacists / technical staff

Federal makes and prices, provinces sell: Manufacturing licences, registration and pricing are federal (DRAP); sale licences are provincial.

Sale licences are issued by the provinces, not by DRAP.
Manufacturing licences are granted by the Central Licensing Board, not the Registration Board.
Price deregulation in February 2024 (SRO 228(I)/2024) did not apply to medicines on the National Essential Medicines List.
Semi-basic and experimental licences exist alongside formulation, basic and repacking licences.
A medical store is not the same as a pharmacy; the qualified person differs.

Attempt the Pricing and Licensing MCQs while the notes are fresh. Anything you get wrong is saved to your incorrect list for the next revision round.