India Pharmacy Drug License Inspection Checklist

Comprehensive India pharmacy drug license inspection checklist for D&C Act compliance.

  • Industry: Healthcare
  • Frequency: Annual/Before renewal
  • Estimated Time: 30-45 minutes
  • Role: Registered Pharmacist/Drug Inspector
  • Total Items: 22
  • Compliance: Drugs & Cosmetics Act 1940, D&C Rules 1945, Pharmacy Act 1948

License & Registration

Regulatory compliance

  • Drug license valid?
  • Registered pharmacist present?
  • Pharmacist registration displayed?

Premises

Physical requirements

  • Minimum area 10 sq.m met?
  • Clean, dry, and well-lit?
  • Refrigerator for cold storage drugs?

Storage

Drug storage

  • Schedule H drugs stored separately?
  • Schedule X drugs under lock?
  • No expired drugs in stock?

Records

Documentation

  • Purchase records maintained?
  • Sales records for Schedule H?
  • Prescriptions retained?

Infection Prevention & Control

Infection control per CDC/Joint Commission

  • Hand hygiene compliance observed?
  • Isolation precautions followed correctly?
  • Sharps containers not overfilled?
  • Appropriate PPE available and used?

Patient Safety Verification

Patient identification and safety protocols

  • Two-patient-identifier protocol followed?
  • Fall risk assessment completed?
  • Bed in low position with rails up?

Medication Safety

Medication administration and storage safety

  • Medications stored securely?
  • Controlled substance count accurate?
  • No expired medications in stock?

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Why Use This India Pharmacy Drug License Inspection Checklist?

This india pharmacy drug license inspection checklist helps healthcare teams maintain compliance and operational excellence. Designed for registered pharmacist/drug inspector professionals, this checklist covers 22 critical inspection points across 7 sections. Recommended frequency: annual/before renewal.

Ensures compliance with Drugs & Cosmetics Act 1940, D&C Rules 1945, Pharmacy Act 1948. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the India Pharmacy Drug License Inspection Checklist cover?

This checklist covers 22 inspection items across 7 sections: License & Registration, Premises, Storage, Records, Infection Prevention & Control, Patient Safety Verification, Medication Safety. It is designed for healthcare operations and compliance.

How often should this checklist be completed?

This checklist should be completed annual/before renewal. Each completion takes approximately 30-45 minutes.

Who should use this India Pharmacy Drug License Inspection Checklist?

This checklist is designed for Registered Pharmacist/Drug Inspector professionals in the healthcare 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.

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