Retail Pharmacy Drug License Compliance Checklist - India
This checklist ensures compliance with the Drugs and Cosmetics Act 1940, Drugs and Cosmetics Rules 1945, and Pharmacy Act 1948. Designed for retail pharmacy owners, registered pharmacists, and Drug Inspector inspections across India.
- Industry: Pharmaceutical / Retail
- Frequency: Monthly
- Estimated Time: 30-40 minutes
- Role: Registered Pharmacist / Pharmacy Owner
- Total Items: 21
- Compliance: Drugs and Cosmetics Act 1940, Drugs and Cosmetics Rules 1945 Schedule H, H1, X, Pharmacy Act 1948, Drugs (Prices Control) Order 2013
Drug License and Registration
Validity and display of drug license.
- Drug license displayed prominently at the pharmacy?
- Drug license (Form 20 / 21) valid and not expired?
- Registered pharmacist present during pharmacy hours?
- Pharmacist registration certificate available?
Schedule H and H1 Drug Management
Proper dispensing of prescription medicines.
- Schedule H drugs dispensed only on valid prescription?
- Schedule H1 drugs recorded in separate register with Rx details?
- Prescriptions retained for 2 years (H) and 3 years (H1)?
- Schedule X drugs (psychotropics) in separate locked storage?
Drug Storage Conditions
Appropriate storage of medicines as per product requirements.
- Storage area temperature within prescribed limits?
- Cold chain medicines (insulin, vaccines) stored at 2-8°C?
- Internal / external use drugs separately labelled and stored?
- No expired or damaged drugs on shelves?
- Narcotic drugs in double-locked cupboard (if stocked)?
Purchase and Sales Records
Statutory records for drug purchase and sale.
- Purchase register for Schedule H maintained with supplier invoices?
- Sales register maintained for Schedule H drugs?
- All stock purchased only from licensed wholesalers?
- Bills / invoices retained for 3 years?
Pricing and Labelling Compliance
Compliance with DPCO and labelling regulations.
- No drug sold above MRP printed on pack?
- Price list of essential medicines (NLEM) displayed?
- Expiry dates verified before dispensing every drug?
- Observations and non-compliances noted
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Why Use This Retail Pharmacy Drug License Compliance Checklist - India?
This retail pharmacy drug license compliance checklist - india helps pharmaceutical / retail teams maintain compliance and operational excellence. Designed for registered pharmacist / pharmacy owner professionals, this checklist covers 21 critical inspection points across 5 sections. Recommended frequency: monthly.
Ensures compliance with Drugs and Cosmetics Act 1940, Drugs and Cosmetics Rules 1945 Schedule H, H1, X, Pharmacy Act 1948, Drugs (Prices Control) Order 2013. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Retail Pharmacy Drug License Compliance Checklist - India cover?
This checklist covers 21 inspection items across 5 sections: Drug License and Registration, Schedule H and H1 Drug Management, Drug Storage Conditions, Purchase and Sales Records, Pricing and Labelling Compliance. It is designed for pharmaceutical / retail operations and compliance.
How often should this checklist be completed?
This checklist should be completed monthly. Each completion takes approximately 30-40 minutes.
Who should use this Retail Pharmacy Drug License Compliance Checklist - India?
This checklist is designed for Registered Pharmacist / Pharmacy Owner professionals in the pharmaceutical / retail industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.