Drug License Compliances
🏥 Drug License Compliances in India
Once your drug license is issued under the Drugs and Cosmetics Act, 1940, ensuring timely compliance is crucial to maintain validity, avoid penalties, and uphold public trust.
📋 Key Post-Registration Compliances
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Compliance Area
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Description
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|---|---|
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✅ Display of License
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Must be prominently displayed at the business premises.
|
|
📑 Record Maintenance
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Maintain records of purchase, sale, and stock as per Rule 65.
|
|
🔄 Renewal of License
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File renewal application within 6 months before expiry.
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🔁 Retention Fees (Form 21/21B)
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Pay retention fees every 5 years (if applicable).
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|
👨⚕️ Qualified Personnel
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Employ a registered pharmacist or competent person for sale activities.
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🧪 Drug Storage Conditions
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Follow temperature and humidity requirements (refrigerators, etc.).
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|
📢 Intimation of Changes
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Inform licensing authority for changes in constitution, address, or staff.
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📬 Inspections & Audits
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Cooperate with regular inspections by Drug Inspectors.
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|
📤 Annual Returns (Form 20, 20B etc.)
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Submit if applicable for wholesalers/manufacturers.
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❌ Ban/Recall Protocols
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Must comply immediately with any drug recall or ban directives.
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📅 Compliance Calendar (Annual)
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Month
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Activity
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|---|---|
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January
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Internal audit of stock & record books
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March
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Submit stock and sale summaries (if required)
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April
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Intimation of structural/staff changes
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July
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Verify equipment calibration & storage logs
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|
October
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Internal compliance review
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|
November
|
Prepare for renewal (if license is expiring)
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|
December
|
Annual return filing (wholesale/manufacture)
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🔗 Download:
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📥 Compliance Calendar (Excel)
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📥 Drug Sale Register Format (Word)
🧾 Donor Certificate (For Non-Profit Drug Distributors)
(If applicable under charitable drug distribution)
A custom-branded Donor Certificate Template is available for download.
-
🔗 Download Certificate Template (Word)
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