What to keep ready for a drug inspector

This is an operations checklist, not a legal opinion

Drug sale in Pakistan sits under the Drugs Act, 1976, with day-to-day licensing handled by the provinces. The worked example below follows conditions described in the Punjab Drugs Rules, 2007, including the duty to keep purchase invoices and to record certain sales in a register.

Sindh, Khyber Pakhtunkhwa, Balochistan, and Islamabad have their own drug rules. Form numbers and schedule names are not something to copy from another province. Read your own licence and, if you are unsure, ask the drug inspector who renews it. This page cannot tell you that you are compliant.

Keep the licence visible and current

In Punjab, a pharmacy and a medical store are not the same licence. A pharmacy is supervised by a person registered as a pharmacist. A medical store is supervised by a person registered in the relevant category under the Pharmacy Act, 1967. The licence should be the current one, and it should be displayed where the rules require it.

Know which licence you hold before you stock a category of medicine your licence does not allow. In Punjab, a medical store is not permitted to sell or store drugs listed in Schedule G. If you do not know whether an item falls in that schedule, do not guess from memory or from another shop's shelf.

Renewal has a date. An expired licence is not a paperwork detail you fix after a visit.

Purchase records

Keep the supplier invoice and warranty. Punjab's rules say a purchase invoice or bill is to be preserved for at least three years, and that sale records, bills, or counterfoils are also kept for at least three years from the sale.

File them so you can find a batch later: supplier, date, invoice number, product, batch, quantity. A carton with no bill is a problem when someone asks where it came from.

Buy only from a seller who is allowed to sell to you. The same Punjab rules say a seller supplies a drug to a holder of a valid drug sale licence or to a registered medical practitioner, and issues an invoice and warranty.

Prescription-only and controlled drugs

Punjab defines narcotic, psychotropic, or controlled drugs by reference to Schedules B and D. Those drugs, and preparations containing them, are not to be sold except on a prescription of a registered medical practitioner. The original prescription stays with the pharmacy or medical store.

The rules also describe a narrow emergency case, which must be written in the register. They do not describe a casual verbal order as a substitute for a prescription. A sale to a registered medical practitioner, a hospital dispensary, or certain institutions can fall under a different part of the same rule. If you are not sure the buyer qualifies, do not treat the sale as exempt.

When you supply a Schedule B or D drug, Punjab asks for a register entry at the time of supply, including:

• Serial number and date
• Prescriber
• Patient
• Drug and manufacturer
• Quantity
• Batch number
• Signature of the qualified person
• Quantity purchased and the balance

The prescription itself has to be written, signed, dated, name the patient and address, and state the total quantity and the dose. Put the register serial on the prescription.

Do not copy this list into another province until you have checked that province's rule. Do not skip the paper register because a computer also stored the sale.

Storage and expired stock

Stock must be stored so that its quality holds: labelled shelves, a working fridge for products whose pack requires cold storage, and no mix-up between saleable stock and stock you have decided not to sell.

Do not sell an expired drug. Separate it, record the batch and quantity, and follow the inspector's direction and the supplier agreement for return or destruction. Selling it because the patient is waiting is not a workaround.

A folder you can open in five minutes

Keep one folder, physical or clearly filed, with:

• The current licence and the qualified person's registration
• Purchase invoices for the period your province requires
• The register for drugs that need a prescription record
• A note of quarantined and expired batches
• Fridge temperature notes for cold-chain stock

If producing those takes a search through several notebooks, fix the filing on a quiet morning. The visit is the wrong time to reconstruct a batch.

Key takeaways

• Confirm the rule in your own province. Punjab is the example here, not the national form.
• Display a current licence and stay inside what that licence allows.
• Keep purchase bills for the period the rules state.
• Record controlled and scheduled sales in the register at the time of supply.
• Never sell expired stock.