Requirements for License for Repacking of Drugs: Key points

Record of repacking of drugs should be retained for 05 years

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Medicine
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Table of Contents

Deputy State Drugs Controller |
Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
Lalit Kr. Goel

Last Updated on June 8, 2024 by The Health Master

Repacking of Drugs

Here are some major points for the requirements for License for Repacking of Drugs

1. To obtain license for ‘Repacking of Drugs’, application is to be submitted on Form 24B (read with rule 70 (rule 69 (a)) of Drugs Rules, 1945.

2. License for ‘Repacking of Drugs’ is granted on Form 25B.

3. Premises on which license for ‘Repacking of Drugs’ is to be issued must comply with conditions as per Schedule M Rule 71-A(1) of the Drugs Rules and there should be adequate arrangement for storage of drugs.

4. License fee is Rs. 700/- accompanied by up to 10 items per license (Rule 69(2)(a) of the Drugs Rules).

5. Fee for additional items (beyond 10 free items with license) is Rs. 100/- per item.

6. Validity of license is 05 years from the date of issuance and extended for further 05 years on retention.

7. Application for Drug Formulation containing single active ingredients shall be made in proper name only.

8. For grant of license for repacking of drugs, Joint inspection by CDSCO and State is required under Rule 73 AB.

9. Repacking operations should be carried out under supervision of Competent Person.

10. As per rule 71-A(3) (Rule 71A(1)) of the Act Competent Person should have following minimum qualifications:

  • Diploma in Pharmacy or Registered under Pharmacy Act, 1948 or
  • A person who has passed the Intermediate examination with Chemistry as one of the principal subjects or an examination equivalent to it or an examination recognized by the Licensing Authority as equivalent to it or
  • Passed the Matriculation examination or an examination recognized by the Licensing Authority as equivalent to it and has had not less than four years practical experience in the manufacture, dispensing or repacking of drugs.

11. Firm should have adequate arrangements for testing of drugs in its own premises separate from the repacking unit or have arrangements with institutions approved by the Licensing Authority for tests of the drugs on firm’s behalf.

12. Testing of all APIs and the Finish Goods is mandatory and the record of testing should be maintained as specified in the Rules.

13. Licensee shall maintain reference sample of every batch of the drug repacked Quantity of reference sample must be at least twice the quantity required for testing.

14. Reference samples should be kept for 03 months after the expiry date of drug.

15. Record of repacking of drugs should be retained for 05 years.

16. In revised Schedule M Part XIII, list of machinery and required area is defined.

17. Repacking License can be issued only for 86 drugs out of 89 drugs as per DCGI’s circular issued in the year 1982.

18. There is no provision for Loan License regarding repacking of drugs in the Act.

19. There is no provision for repacking of Sprit.

Must read: Latest Circulars, Notices & Guidelines: CDSCO, DCGI

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