Key Highlights of the recent amendments in the Drugs and Cosmetic Rules 2024

Dr R Valavan, BHMS, MD (Hom. Pharm), MBA, PhD
Head – Scientific, Medical & Regulatory Affairs, Schwabe India

These rules may be called the Drugs (Fifth Amendment) Rules, 2024. They shall come into force on the date of their publication in the Official Gazette. 28th October, 2024

1. Classification of New Combinations

Any new combination of homeopathic medicines, even if the ingredients are listed in pharmacopoeia, will now be classified as a “New Homeopathic Medicine.” This classification mandates prior approval from CDSCO or the Ayush Ministry, helping to control the proliferation of unchecked combinations.

2. Exclusivity Period for New Medicines

A new homeopathic medicine will retain its “new” status for five years, ensuring exclusive manufacturing rights. This allows companies to secure returns on investment in R&D by preventing immediate duplication.

3. Consolidation of Potencies

All potencies of a single homeopathic medicine will now be treated as one product for licensing fee purposes, reducing costs associated with multiple potencies.

4. Loan License Provision

The recent amendments permit loan licensing in homeopathy, enabling companies to leverage third-party facilities without significant time or financial investment. The packaging will display:

Manufactured by:
ABC India Pvt. Ltd., 123, XYZ Street, City, State. Pin – 123456.

Importantly, the third-party manufacturer’s name will not appear, as manufacturing will be under the brand owner’s Quality Assurance team.

5. Perpetual Licensing

Homeopathic manufacturing and sale licenses will now be perpetual, requiring only a retention fee every five years instead of periodic renewals.

For further inquiries, please contact:

📱 +91-9312309186

✉  drvalavan@yahoo.com