A medical store looks like retail. Legally it is the sale of a controlled product under a licensing regime with criminal consequences for breach — including prosecution before a Drug Court.
The gap between how casually these businesses are often run and how seriously the law treats them is where the trouble sits.
The licence
Retail and wholesale sale of drugs requires a drug sale licence issued by the provincial health authority under the Drugs Act 1976 and the applicable rules, with DRAP setting the federal framework for registration, quality and pricing.
Broadly:
- Licence by category — retail (medical store or pharmacy) or wholesale, and these are distinct. A retail licence does not permit wholesale supply
- Approved premises meeting the prescribed area, fittings and storage requirements
- A qualified person — a registered pharmacist for a pharmacy, or the qualification prescribed for a medical store — actually present as required, not merely named on the application
- Inspection before grant, and periodically thereafter
- Renewal on time; a lapsed licence means unlicensed sale, which is an offence rather than a paperwork issue
Sale of drugs by an unlicensed person, or from unlicensed premises, is prosecuted.
The qualified person requirement
This is where enforcement concentrates, because the practice of "renting" a pharmacist's credentials while an unqualified salesperson runs the counter is widespread and well known to inspectors.
Two things follow. The pharmacist whose registration is used is exposed professionally. And the licensee is exposed to cancellation and prosecution.
If you cannot staff the shop properly, you cannot run it lawfully.
Storage, handling and cold chain
- Temperature control for the premises, monitored and recorded
- Cold chain for vaccines, insulin and biologicals — refrigeration with temperature logging, and a documented plan for power failure. A load-shedding gap that spoils stock is both a loss and a safety issue
- Expiry management — physically segregated, recorded, and returned or destroyed through a documented route. Expired stock found on shelves is the most common inspection finding
- Segregation of drugs from other goods
- Security for controlled and narcotic substances, with the additional records those require
Prescriptions and records
- Dispense prescription-only medicines against a valid prescription from a registered practitioner. This is a legal obligation, not a courtesy, and casual over-the-counter supply of antibiotics and controlled drugs is exactly what inspectors look for
- Maintain purchase and sale records, invoices and batch numbers, so any product can be traced to its source
- Buy only from licensed distributors, and keep the invoices. This is your single best protection if a batch is later alleged to be spurious
- Comply with price control — selling above the notified maximum retail price is an offence
- Act on recall notices promptly and record what you did
Inspections and Drug Court proceedings
A drug inspector may enter, inspect, take samples and seize. What follows a sample is a report from the government analyst, and where a drug is reported substandard, spurious or misbranded, proceedings follow before a Drug Court against those in the chain — which includes the retailer.
What decides these cases:
Your invoices. A retailer who bought from a licensed distributor with proper documentation is in a fundamentally different position from one who cannot say where the stock came from. This is the whole defence, and it depends on record-keeping done before anything went wrong.
Procedure on sampling. Samples must be taken and dealt with in the manner the law prescribes, including the portions given to the person from whom they are taken and the right to have a sample tested. Departures from procedure matter.
The right to challenge the analysis, within the time allowed.
Do not sign statements or dispose of related stock before taking advice, and do not treat a sample notice as routine. See bail after arrest and how to file an FIR.
Setting the business up
Structure. A company, given the prosecution risk and the value of stock. See choosing a business structure.
Premises. Check permitted use and the lease before fitting out — the licence attaches to the premises, so a lease you can lose is a licence you can lose. See commercial lease negotiation and building control.
Tax. NTN, sales tax where applicable, and withholding obligations on rent and supplies. See sales tax registration and withholding tax obligations.
Staff. Appointment letters, EOBI and SESSI, and a harassment policy with the statutory committee. See employment contracts and the employer's harassment duties.
Insurance, including stock and public liability.
Importing, distributing or manufacturing
A different and heavier regime: DRAP registration of the product, import authorisation, and manufacturing licensing with GMP requirements. Do not assume a sale licence permits import. See food and pharma licensing and permits and restricted imports.
Online pharmacy and delivery
Selling medicines online does not remove any of the above — the licence, the qualified person, the prescription requirement and the cold chain all still apply, and delivery adds handling and temperature risk. Treat it as a licensed pharmacy that happens to deliver, not as e-commerce that happens to sell medicine.
See starting an online store and data protection — prescription data is among the most sensitive you can hold.
Counterfeit medicines
If you discover you have been supplied spurious stock, quarantine it, keep the invoices, and report it. Your claim is upstream against the supplier, and your protection is the documentation. See counterfeits and brand enforcement and recovering money owed.
How the firm can help
We obtain and renew drug sale licences, review premises and staffing against the requirements, prepare the record-keeping systems that make an inspection survivable, respond to inspector action and sampling, and defend proceedings before Drug Courts and licence cancellation.