Pharmacy Regulatory & Drug Inspector Audit (PDF) with Amit Patil

Are your pharmacy records ready for a surprise Drug Inspector audit today?

Under the Drugs and Cosmetics Act & Rules, incomplete Schedule H1 registers, missing fridge temperature logs, or unsegregated expired strips can lead to immediate show-cause notices, product seizures, or license suspension.

Don't waste hours creating manual formats or paying compliance fines. This complete Retail Pharmacy Regulatory & Audit Kit gives you standard, inspection-tested templates ready to print and bind immediately.

What's inside (Print-ready A4 PDF)

1. Daily Refrigerator Temperature Log (2-8 C) - month sheet with corrective-action column and notes.
2. Schedule H1 Prescription Register - laid out around the Rule 65(9) requirements, with a filled sample page showing how to write entries.
3. Schedule H Prescription Record
4. Schedule X Controlled-Substance Ledger - opening / inward / outward / balance format with a sample page.
5. Expired, Damaged & Recalled Drug Return Register + printable red QUARANTINE tags
6. Registered Pharmacist Attendance & Dispensing Record
7. 15-Point Pre-Audit Checklist - a self-check for licences, pharmacist presence, registers, cold storage and quarantine.
8. Bonus: Inspector Visit Record, inspection-day protocol, five corrective-action SOPs and a daily/weekly/monthly routine calendar.

Who it's for

• Retail medical store owners and chemists
• Registered pharmacists (D.Pharm / B.Pharm)
• Hospital OPD / dispensary in-charges

Formats

Print-ready A4 PDF

Please note

Templates and record-keeping aids, not legal advice. Formats and requirements can vary by State and Schedules are amended from time to time - confirm with your State Drugs Control Department. Using the kit does not by itself guarantee any inspection outcome.