The Drugs (Fifth Amendment) Rules, 2024 has introduced changes to the licensing and manufacturing processes for Ayurveda, Siddha, Sowa-Rigpa, Unani, Homeopathic medicines in India. These regulations were published on October 29, 2024.
Focus on New Homeopathic Medicines
The rules define “New Homeopathic Medicines” and establishes a process for their import and approval. It also requires evidence of safety, therapeutic efficacy, and minimum homoeopathic provings for new medicines.
New medicines will be considered “new” for five years after initial approval.
Streamlined Licensing Process
The rules introduce online applications through the e-AUSHADHI portal for selling, stocking, and distributing Homoeopathic medicines. It has standardize fees for license applications. The licenses for retail and wholesale sale of Homoeopathic medicines will be perpetual, subject to self-declaration of adherence to regulations every five years.
Strengthened Quality Control
- Makes a Good Manufacturing Practices (GMP) certificate mandatory for obtaining a manufacturing license.
- Defines the qualifications required for personnel supervising Homoeopathic medicine manufacture.
- Establishes regular inspections (at least once every five years) of manufacturing facilities.
- Introduces a system for perpetual validity of GMP certificates with renewal fees every five years.
Improved transparency allows online access to license applications and potentially details of manufactured medicines if online records are maintained.
These regulations aim to improve the quality, safety, and accessibility of Homeopathic medicines in India. The online application system and perpetual licenses should simplify the process for legitimate manufacturers and sellers. The focus on New Homeopathic Medicines and stricter quality control measures aims to ensure the efficacy and safety of these products.
