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Schedule A Demo

General Condition of licences under Drugs Rules, 1945

(Applicable to licences in Forms 20, 20A, 20B, 20F, 20G, 21 and 21B under the Drugs Rules, 1945)

The licences listed above shall be governed by the conditions stated in the respective licence forms and the following general conditions as per Rule 65:

Compounding and Supply under Pharmacist Supervision

  • Any drug compounded or prepared on the licensed premises must be done by or under the direct personal supervision of a Registered Pharmacist.
  • Supply of any prescription drug (other than wholesale dealing) must be carried out by or under the personal supervision of a Registered Pharmacist.

Record of Supply on Prescriptions

When supplying a drug (other than Schedule X) on the prescription of a Registered Medical Practitioner, the following must be recorded at the time of supply in a Prescription Register:

  1. Serial number of entry
  2. Date of supply
  3. Name and address of prescriber
  4. Name and address of patient / animal owner (if veterinary use)
  5. Name of drug / preparation and quantity (or formulation with ingredients if extemporaneously prepared)
  6. For drugs under Schedule C, H, H1: manufacturer name, batch number, expiry date
  7. Signature of the Registered Pharmacist supervising the supply

Permitted alternatives:

  • For drugs supplied in original sealed containers, particulars may instead be maintained in serially numbered cash/credit memo books.
  • When repeat supply of a previously dispensed prescription occurs, entry may reference earlier register details.

Exemptions from detailed entry:

  • Supplies under Employees State Insurance Scheme where all particulars appear on the prescription
  • Drugs not in Schedule C, H, or H1, supplied in original sealed containers, provided:
    • Prescription is stamped with supplier name and supply date
    • Cash/credit memo requirements under Rule 65(4)(3) are followed

Schedule H1

  • Must be recorded in a separate register, retained for 3 years.

Declaration of method

  • The licensee must declare to the Licensing Authority whether records will be maintained in a register or in cash/credit memo books.

Supply by Retail Without Prescription — Schedule C Drugs

Retail supply without prescription must be recorded either:

  • In a special register (recording date, purchaser’s details, drug name/quantity, batch number, expiry, responsible person’s signature), or
  • In a serially numbered cash/credit memo book with the same details (except serial number)

Licensing Authority may mandate register-only maintenance if memo copies are not legible.

Carbon copies must be retained.

Records of Purchases – Retail Sales

Licensees must maintain purchase records showing:

  • Date of purchase
  • Supplier’s name, address, and licence number
  • Drug name, quantity, batch number
  • Manufacturer’s name

Purchase bills / memos must be serially numbered and filed chronologically.

Supply by Wholesale

Wholesale dealing must be accompanied by a cash/credit memo showing:

  • Date of sale
  • Purchaser details and their sale licence number
  • Drug name, quantity, batch number
  • Manufacturer name
  • Signature of competent supervising person

Carbon copies must be retained for 3 years.

Wholesale purchase records must meet the same requirements as retail purchase records.

Inspection of Records

All required registers and records must be:

  • Produced on demand to Inspectors under the Act
  • Accessible for verification and compliance checks

Record Retention

Unless otherwise stated,

  • All records must be retained for not less than two years from the date of last entry.

Duplication Avoidance

Where required particulars are already recorded in another register maintained under any other applicable law, separate entries in a drug register are not necessary.

Special Controls — Schedules H, H1, and X

  • Retail sale permitted only on prescription of a Registered Medical Practitioner
  • For Schedule X drugs, prescriptions must be:
    • In duplicate
    • One copy retained for 2 years
  • Supply of these drugs to institutions / RMPs allowed only against signed written orders, retained for 2 years

Dispensing requirements:

  • Prescription may not be repeated unless specifically authorised
  • Multiple dispensing must strictly follow stated intervals/repetitions
  • Stamp prescription with seller’s name, address, and dispensing date

Schedule X storage requirements:

  • Under lock and key in a separate secured cupboard/drawer, or
  • In a restricted access area separated from the rest of premises

Disclaimer: The information contained in this Article is intended solely for personal non-commercial use of the user who accepts full responsibility of its use. The information in the article is general in nature and should not be considered to be legal, tax, accounting, consulting or any other professional advice. We make no representation or warranty of any kind, express or implied regarding the accuracy, adequacy, reliability or completeness of any information on our page/article. 

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Schedule A Demo