Compliance
Drug Inspector Visit — What They Check and How to Be Always Ready
A complete checklist of what Drug Inspectors examine during pharmacy inspections — so you're never caught off guard.
A Drug Inspector (DI) visit can happen without advance notice. Under the Drugs and Cosmetics Act, Drug Inspectors have the authority to enter any pharmacy during business hours, inspect premises, check records, and take samples. Being prepared at all times — not just before a scheduled inspection — is the only safe approach.
Complete Drug Inspector Inspection Checklist
Licences and Certificates
- ✅ Original Drug Licence (Form 20 / 21) displayed prominently
- ✅ Pharmacist's Registration Certificate (current, not expired)
- ✅ GST Registration Certificate
- ✅ Shop and Establishment Licence
- ✅ Drug licence not expired — valid for 5 years from date of issue
Premises and Storage
- ✅ Store area meets minimum size requirement (as per licence)
- ✅ Medicines stored away from direct sunlight
- ✅ Refrigerator present and functioning (for cold chain medicines)
- ✅ No medicines stored on the floor — all on shelves
- ✅ Separate storage for Schedule X / narcotic substances (locked)
- ✅ Premises clean, no evidence of pests
Records and Registers
- ✅ Purchase register (or invoices filed in order) for last 2 years
- ✅ Schedule H prescriptions retained for 2 years
- ✅ Schedule X register (if stocking X drugs) — complete and current
- ✅ Schedule H1 register (if stocking H1 drugs)
- ✅ Poisons register (if stocking scheduled poisons)
Products on Shelf
- ✅ No expired medicines on the dispensing shelf — must be segregated
- ✅ No substandard or banned medicines
- ✅ Labels legible — batch number, expiry, MRP clearly visible
- ✅ No medicines with damaged packaging being sold
Personnel
- ✅ Qualified pharmacist present during trading hours
- ✅ Pharmacist can be identified and has their registration on person or available
Most common violations found: Expired medicines on shelf (most common), expired drug licence (many owners miss renewal), pharmacist absent during inspection, and Schedule X register not maintained properly.
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Start Free →Can a Drug Inspector take samples from my pharmacy?
Yes. Under Section 22 of the Drugs and Cosmetics Act, a Drug Inspector can take samples of any medicine for testing at a government analyst's laboratory. They must follow the prescribed sampling procedure (take sample in triplicate, give you one portion, keep one, send one for analysis). Samples are taken at the manufacturer's expense — you are not charged. If a sample fails quality testing, it can lead to prosecution.
How often does a Drug Inspector visit a pharmacy?
There is no fixed schedule. Inspections can be routine (annual or biennial in many states), triggered by a complaint, or random. High-risk classifications (Schedule X licence holders, pharmacies near hospitals) tend to be inspected more frequently. Plan as if a visit could happen any day.