Codeine Phosphate and its Regulations in India

Codeine Phosphate and its formulations are included in Schedule H1 of the Drugs and Cosmetics Act, 1940 (serial number 20).

1158
Regulation Law Act
Regulation
Deputy State Drugs Controller |
Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
Lalit Kr. Goel

Last Updated on April 22, 2024 by The Health Master

Codeine Phosphate

Know all about Codeine Phosphate and its preparations and Download all notifications related to Codeine Phosphate, the links are given below:

1. Codeine Phosphate:

  • An official drug listed in the Indian Pharmacopoeia (IP).

2. Dosage Forms:

  • Primarily available in syrups and tablets.

3. Narcotic Drug Classification:

  • Codeine Phosphate API is classified as a Narcotic Drug under the Narcotic Drugs & Psychotropic Substances Act, 1985 (NDPS Act).

4. Drugs and Cosmetics Act Coverage:

  • Codeine Phosphate and its formulations are included in Schedule H1 of the Drugs and Cosmetics Act, 1940 (serial number 20).

5. Manufactured Drug Status:

  • Notified as a “Manufactured Drug” under the NDPS Act, 1985 (serial no. 35 vide notification S.O. no. 826 (E) dated 14.11.1985).

6. Quota Allotment for Purchase and Use:

  • Allopathic Drug Manufacturers require a quota allotment issued by the Excise & Taxation Department for purchasing and using Codeine Phosphate API.

7. Exemptions from NDPS Act:

  • Codeine Phosphate formulations:
    • Up to 100mg per dosage unit.
    • Up to 2.5% concentration in undivided preparations.
  • Exempt from NDPS Act, 1985, subject to compliance with Drugs and Cosmetics Act (1940) and Rules (1945).

8. Plain Codeine Phosphate:

  • Covered under the NDPS Act, 1985 (without combination with other drugs).

9. Drug Sale License Requirement:

  • A Drugs Sale License (Retail/Wholesale) under the Drugs Act is mandatory for selling Codeine Phosphate formulations.

10. Storage, Possession, Sale, and Distribution License:

  • A license issued under the provisions of State NDPS Rules of the respective State Government is required.

11. Record Keeping:

  • Licensees must maintain sale/purchase records of Codeine Phosphate. Failure to do so is a contravention of Rule 65A of the NDPS Act, 1985.

12. Unlicensed Activities:

  • Unlicensed manufacturing, stocking, and sale of Codeine Phosphate and its formulations are offenses under the NDPS Act, 1985.

13. Offence Severity for Unlicensed Stocking:

  • Depends on the quantity:
    • Small quantity: 10 grams (vide notification S.O. no. 1055 (E) dated 19.10.2001).
    • Commercial quantity: 1.0 kilogram.

14. Labeling Requirements:

  • “NRx” labeling is mandatory for single-ingredient Codeine Phosphate drugs.
  • Not mandatory for formulations/Fixed Dose Combinations (with other drugs) if the condition specified at serial number 35 of the NDPS Act is fulfilled.

15. Banned Combination:

  • Fixed Dose Combination of Codeine Phosphate + Chlorpheniramine Maleate + Menthol Syrup (vide notification S.O. no. 2404 dated 02.06.2023).

16. Essential Narcotic Drug:

  • Codeine (narcotic drug) is notified as an essential narcotic drug for medical and scientific use (vide notification S.O. no. 1181 (E) dated 05.05.2015).

17. Possession by Medical Practitioners:

  • A Registered Medical Practitioner can possess up to 2,000mg (equivalent to 2 grams) of narcotic drugs for use in their practice, not for sale or distribution.

18. Codeine Stock by Recognized Medical Institutes:

  • Vide notification GSR 359 (E) dated 05.05.2015, recognized medical institutes can possess codeine upon approval from the State Drugs Controller of the State.

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