Key Changes for Homoeopathic Medicines: GSR 669(E) dated 28-10-2024

Last Updated on November 27, 2024 by The Health Master

Homoeopathic Medicines

The Ministry of Ayush has recently issued a notification No. GSR 669(E) dated 28-10-2024 amending the Drugs Rules, 1945, specifically focusing on key changes for homoeopathic medicines.

These amendments aim to streamline regulations and enhance the quality and accessibility of homoeopathic products.

Key changes include revised licensing requirements, updated guidelines for manufacturing and storage, and stricter quality control measures.

These modifications are expected to bolster the credibility of homoeopathy and ensure the safety and efficacy of homoeopathic medicines for patients.

1. Definition of Homoeopathic Medicine:

• Amended to align with definitions of other drugs, providing clarity and linking it to intended use.
• Expanded to include provings through research.
• Refers to homoeopathy books specified in Schedules 1 & 2 of the Drugs and Cosmetics Act, 1940.

2. Import of New Homoeopathic Medicines:

• Safety and therapeutic efficacy will be assessed for import approval.
• Combinations of two or more medicines from official Pharmacopoeia or authorized books, proposed for the first time, will be considered new and require licensing.

3. New Homoeopathic Medicine Status:

• A new medicine retains its “New” status for five years from initial approval.

4. Safety, Therapeutic Efficacy, and Provings:

• Guidelines set by the Central Council for Research in Homoeopathy will be followed.

5. Recognition of Pharmacopoeias:

• French Homoeopathic Pharmacopoeia and European Pharmacopoeia are now recognized.

6. Licensing Fees:

• Increased from Rs 250/- to Rs 2000/- for both wholesale and retail licenses.

7. Application Process:

• Applications for licenses must be submitted through the e-AUSHADHI portal (www.eaushadhi.gov.in) after notification.
• Licenses will be issued within two months of application.

8. License Exhibitions:

• No license is required to exhibit medicines for promotional purposes at fairs.

9. License Validity:

• Licenses are valid perpetually, subject to submitting a self-declaration every five years confirming adherence to license conditions and regulations.
• No fee is required for retaining license validity.

10. Manufacturing Fees:

• Fees are rationalized:
  • Rs 2000/- for any number of single-ingredient medicines.
  • Rs 200/- per product for combination medicines.

11. Existing Licensees with Valid GMP Certificate:

• A one-year window is given to seek perpetual license validity:
  • Rs 1000/- for single-ingredient products.
  • Rs 100/- per combination product.
  • Applications through e-AUSHADHI portal upon notification.

12. Loan License for Manufacturing:

• Provisions for obtaining a Loan License for manufacturing are introduced (Form 25-C-1).

13. GMP Certificate Application:

• Application Form 24C2 is prescribed for a Certificate of GMP with a fee of Rs 5000/-.

14. Inspection and Licensing Procedures:

• Procedures for inspection, GMP certification, inspector reports, and Licensing Authority actions are revised and streamlined.

15. Manufacturing License Validity:

• Manufacturing licenses remain valid perpetually.
• Licensees must ensure the validity of their facility’s GMP certificate by paying a Rs 1000/- retention fee every five years before expiry.

16. Record Keeping:

• Maintenance of online manufacturing records is now acceptable.

17. Revised and New Forms:

• Forms 24 C and Form 25 C are revised.
• New forms include Form 24C1, Form 24C2, Form 25C1, and Form 26C1.

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Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

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