The Union Ministry of Ayush has updated the Drugs and Cosmetics Rules, 1945, introducing a significant shift in licensing for Ayurveda, Siddha, Unani, Sowa Rigpa, and Homoeopathy (ASU&H) medicine manufacturers. Under the new amendment, ASU&H manufacturers can now renew their manufacturing and loan licenses to perpetuity by paying a one-time retention fee within the next year, removing the need for periodic renewals. This amendment aims to streamline the compliance process for existing manufacturers holding valid Good Manufacturing Practices (GMP) certificates.
The amendments, notified on October 28, 2024, also introduce changes to licensing fees and applications for both single-ingredient and combination products in homoeopathic medicines. Now, manufacturers of homoeopathic drugs will need to pay Rs 2,000 for single-ingredient medicines and Rs 200 per combination product. Additionally, a fee of Rs 5,000 will be required for a GMP certificate application for homoeopathic manufacturing units.
The Ministry also included Sowa Rigpa under the category of traditional medicines, while revising the qualifications of medical practitioners in ASU&H to align with recent changes brought by the National Commissions for these practices. Furthermore, the amendment includes the French Homoeopathic Pharmacopoeia and the European Pharmacopoeia in the standards recognized for the import and manufacture of homoeopathic medicines in India.
All applications for manufacturing licenses, GMP certificates, and loan licenses are now required to be submitted through the e-Aushadhi portal for streamlined digital processing.