Ayurvedic and Homoeopathic Drug Manufacturers need to Communicate Objections and Suggestions for Proposed Changes in GMP requirements and Regulators about change in Qualifications of Inspector.
The Ministry of AYUSH vide notification GSR 140 (E) dated 14.02.2025 has proposed to amend some requirements with respect to the manufacture for sale of Ayurvedic, Siddha, Unani and Homoeopathic Drugs. The Qualifications of Inspector for ASU drugs are also proposed to be amended. Any objections or suggestions may be submitted within thirty days to Secretary, Ministry of Ayush, New Delhi or emailed to dcc-ayush@nic.in.
The highlights of requirements are as under;
1. Uniform pattern of issuing Licence Numbers provided.
2. Font size of 9 point to be ensured for label and insert information or may be through QR code as an alternate option.
3. Proprietary ASU drugs may be granted based on accelerated stability studies if real time data not available.
4. Inspection of manufacturing units to be as per risk based approach.
5. Inspectors to be qualified with degree in ASU system or in Ayurveda Pharmacy.
6. Schedule M1 –
a. Premises not to be used for any other purpose than Homoeopathic drugs.
b. Strict requirements with respect to area, rooms, water quality, waste disposal, safety measures, plant and equipment, facilities, quality control, personnel, SOPs, etc.
7. Schedule T –
a. Requirements as Ancillary area, elaborate requirements for Location and surroundings, building, stores, raw materials, working space, batch manufacturing records, quality control, etc.
b. Requirements of recommended machinery, equipment for Swarasa, Extracts, and Nasal Spray provided.